Alkermes plc (Alkermes) operates as a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience.
The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, and bipolar I disorder and a pipeline of clinical and preclinical candidates in the development for neurological disorders, including narcolepsy and idiopathic hypersomnia.
Proprietary Products
The company has devel...
Alkermes plc (Alkermes) operates as a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience.
The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, and bipolar I disorder and a pipeline of clinical and preclinical candidates in the development for neurological disorders, including narcolepsy and idiopathic hypersomnia.
Proprietary Products
The company has developed and now commercializes products designed to help address the unmet needs of people living with opioid dependence, alcohol dependence, schizophrenia, and bipolar I disorder.
ARISTADA and ARISTADA INITIO
ARISTADA (aripiprazole lauroxil) is an extended-release intramuscular injectable suspension approved in the U.S. for the treatment of schizophrenia. ARISTADA utilizes the company’s proprietary LinkeRx technology. ARISTADA is a prodrug; once in the body, ARISTADA is likely converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole, which is then hydrolyzed to aripiprazole. ARISTADA is available in four dose strengths with once-monthly dosing options (441 mg, 662 mg and 882 mg), a six-week dosing option (882 mg) and a two-month dosing option (1064 mg). ARISTADA is packaged in a ready-to-use, pre-filled syringe product format. The company exclusively manufactures and commercializes ARISTADA in the U.S.
ARISTADA INITIO (aripiprazole lauroxil) leverages the company’s proprietary LinkeRx and NanoCrystal technologies and provides an extended-release formulation of aripiprazole lauroxil in a smaller particle size compared to ARISTADA, thereby enabling faster dissolution and more rapid achievement of relevant levels of aripiprazole in the body. ARISTADA INITIO, combined with a single 30 mg dose of oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults. The first ARISTADA dose may be administered on the same day as the ARISTADA INITIO regimen or up to 10 days thereafter. The company exclusively manufactures and commercializes ARISTADA INITIO in the U.S.
In December 2024, U.S. Patent No. 12,180,164 relating to ARISTADA and ARISTADA INITIO was granted. The patent has claims to the metabolite N-hydroxymethyl aripiprazole and expires in 2030.
LYBALVI
LYBALVI (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug approved in the U.S. for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, in a single bilayer tablet. LYBALVI is available in fixed dosage strengths composed of 10 mg of samidorphan and 5 mg, 10 mg, 15 mg, or 20 mg of olanzapine. The company exclusively manufactures and commercializes LYBALVI in the U.S.
In January 2025, U.S. Patent No. 12,194,035 relating to LYBALVI was granted. The patent has claims to methods of treatment that cover LYBALVI and expires in 2031.
VIVITROL
VIVITROL (naltrexone for extended-release injectable suspension) is a once-monthly, non-narcotic, injectable medication approved in the U.S. for the treatment of alcohol dependence in patients able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL and for the prevention of relapse to opioid dependence, following opioid detoxification. VIVITROL uses the company’s polymer-based microsphere injectable extended-release technology to deliver and maintain therapeutic medication levels in the body through one intramuscular injection every four weeks. The company exclusively manufactures and commercializes VIVITROL in the U.S.
Licensed Products and Products Using the Company’s Proprietary Technologies
The company has licensed products to third parties for commercialization and has licensed the company’s proprietary technologies to third parties to enable them to develop, commercialize, and/or manufacture products. The company receives royalties and/or manufacturing and other revenues from the commercialization of these products under the company’s collaborative arrangements with these third parties. Such arrangements include, among others, the following:
Products Using the Company’s Proprietary Technologies
INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI
INVEGA SUSTENNA/XEPLION (paliperidone palmitate), INVEGA TRINZA/TREVICTA (paliperidone palmitate) and INVEGA HAFYERA/BYANNLI (paliperidone palmitate) (collectively, the ‘long-acting INVEGA products’) are long-acting atypical antipsychotics owned and commercialized worldwide by Janssen. These products incorporate the company’s technologies.
INVEGA SUSTENNA is approved in the U.S. for the treatment of schizophrenia and for the treatment of schizoaffective disorder as either a monotherapy or adjunctive therapy. Paliperidone palmitate extended-release injectable suspension is approved in the European Union (‘EU’) and other countries outside of the U.S. for the treatment of schizophrenia and is marketed and sold under the trade name XEPLION. INVEGA SUSTENNA/XEPLION is manufactured by Janssen.
INVEGA TRINZA is approved in the U.S. for the treatment of schizophrenia in patients who has been adequately treated with INVEGA SUSTENNA for at least four months. TREVICTA is approved in the EU for the maintenance treatment of schizophrenia in adult patients who are clinically stable on XEPLION. INVEGA TRINZA/TREVICTA is manufactured by Janssen.
INVEGA HAFYERA is approved in the U.S. for the treatment of schizophrenia in patients who has been adequately treated with INVEGA SUSTENNA for at least four months or INVEGA TRINZA for at least three months. BYANNLI is approved in the EU for the maintenance treatment of schizophrenia in adult patients who are clinically stable on XEPLION or TREVICTA. INVEGA HAFYERA/BYANNLI is manufactured by Janssen.
RISPERDAL CONSTA
RISPERDAL CONSTA (risperidone long-acting injection) is a long-acting atypical antipsychotic owned and commercialized worldwide by Janssen that incorporates the company’s proprietary technologies. RISPERDAL CONSTA is approved in the U.S. for the treatment of schizophrenia and as both monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder. RISPERDAL CONSTA is approved in numerous countries outside of the U.S. for the treatment of schizophrenia and the maintenance treatment of bipolar I disorder. RISPERDAL CONSTA uses the company’s polymer-based microsphere injectable extended-release technology to deliver and maintain therapeutic medication levels in the body through just one intramuscular injection every two weeks. RISPERDAL CONSTA microspheres are exclusively manufactured by the company.
Licensed Product
VUMERITY
VUMERITY (diroximel fumarate) is a novel, oral fumarate with a distinct chemical structure that is approved in the U.S., the EU and several other countries for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Under the company’s license and collaboration agreement with Biogen, Biogen holds the exclusive, worldwide license to develop and commercialize VUMERITY.
Key Development Program
The company’s R&D focuses on the development of innovative medicines in the field of neuroscience that are designed to address unmet patient needs. As part of the company’s ongoing R&D efforts, the company has devoted, and will continue to devote, significant resources to conducting preclinical work and clinical studies to advance the development of new pharmaceutical products. The discussion below highlights the company’s current key development program. Drug development involves a high degree of risk and investment, and the status, timing and scope of the company’s development programs are subject to change.
ALKS 2680
ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (‘OX2R’) agonist in the development for the treatment of narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Orexin, a neuropeptide produced in the lateral hypothalamus, is considered to be the master regulator of wakefulness due to its activation of multiple, downstream wake-promoting pathways that project widely throughout the brain. Targeting the orexin system may address excessive daytime sleepiness across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease. Once-daily oral administration of ALKS 2680 was previously evaluated in a phase 1 study in healthy volunteers and patients with narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia and is currently being evaluated in two phase 2 studies: Vibrance-1 in patients with narcolepsy type 1 and Vibrance-2 in patients with narcolepsy type 2. The company expects to initiate Vibrance-3, a phase 2 study in patients with idiopathic hypersomnia, in the first half of 2025.
Collaborative Arrangements
The company has entered into several collaborative arrangements to develop and commercialize products and, in connection with such arrangements, to access technological, financial, marketing, manufacturing and other resources, including the arrangements described below.
Janssen
INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI
Under an exclusive license agreement with Janssen, the company provided Janssen with rights to, and know-how, training and technical assistance in respect of, the company’s small particle pharmaceutical compound technology, known as NanoCrystal technology, which was used to develop the long-acting INVEGA products, and the company received milestone payments from Janssen upon the achievement of certain development goals.
In November 2021, the company received notice from Janssen of partial termination of the license agreement, following which Janssen ceased paying the company royalties related to the U.S. sales of INVEGA SUSTENNA, INVEGA TRINZA, and INVEGA HAFYERA. In April 2022, the company commenced binding arbitration proceedings related to, among other things, Janssen’s partial termination of this license agreement and Janssen’s royalty and other obligations under the agreement. In May 2023, the arbitral tribunal (the ‘Tribunal’) in the arbitration proceedings issued a final award (the ‘Final Award’) that served to reinstate the Janssen royalties and required payment by Janssen of back royalties and interest for amounts owed but not yet paid since the effective date of the partial termination. The Final Award also provided, among other things, that the company was entitled to royalty revenues from Janssen related to net sales of INVEGA SUSTENNA through August 20, 2024, INVEGA TRINZA through the second quarter of 2030 (but no later than May 2030 when the license agreement expires) and INVEGA HAFYERA through May 2030 (when the license agreement expires).
RISPERDAL CONSTA
Under a product development agreement, the company collaborated with Janssen on the development of RISPERDAL CONSTA. Under the development agreement, Janssen provided funding to the company for the development of RISPERDAL CONSTA, and Janssen is responsible for securing all necessary regulatory approvals for the product.
Under two license agreements, the company granted Janssen and an affiliate of Janssen exclusive worldwide licenses to use and sell RISPERDAL CONSTA. Under the company’s license agreements with Janssen, the company receive royalty payments equal to 2.5% of Janssen’s end-market net sales of RISPERDAL CONSTA in each country where the license is in effect based on the quarter when the product is sold by Janssen. The licenses granted to Janssen expire on a country-by-country basis upon the later of the expiration of the last patent claiming the product in such country; or 15 years after the date of the first commercial sale of the product in such country, provided that in no event will the license granted to Janssen expire later than the twentieth anniversary of the first commercial sale of the product in each such country, with the exception of Canada, France, Germany, Italy, Japan, Spain, and the United Kingdom, in each case, where the fifteen-year minimum shall pertain regardless. After expiration, Janssen retains a non-exclusive, royalty-free license to manufacture, use and sell RISPERDAL CONSTA.
The company exclusively manufactures RISPERDAL CONSTA at its Wilmington, Ohio facility for commercial sale. Under the company’s manufacturing and supply agreement with Janssen, the company receives manufacturing revenue based on a percentage of Janssen’s net unit sales price for RISPERDAL CONSTA for the applicable calendar year.
Biogen
Under a license and collaboration agreement with Biogen, the company granted Biogen a worldwide, exclusive, sublicensable license to develop, manufacture and commercialize VUMERITY and other products covered by patents licensed to Biogen under that agreement.
Under this license and collaboration agreement, the company received an upfront cash payment and milestone payments related to the achievement of certain milestones, including FDA approval of the NDA for VUMERITY and amendment of the license and collaboration agreement. The company is also eligible to receive additional payments upon achievement of certain milestones, including milestones relating to the first two products other than VUMERITY covered by patents licensed to Biogen under the license and collaboration agreement.
In addition, the company receive a 15% royalty on worldwide net sales of VUMERITY, subject to increases for VUMERITY manufactured and/or packaged by Biogen or its designees, and, under certain circumstances, minimum annual payments for the first five years following FDA approval of VUMERITY. The company is also entitled to receive royalties on net sales of products other than VUMERITY covered by patents licensed to Biogen under the license and collaboration agreement, at tiered royalty rates calculated as percentages of net sales ranging from high-single digits to sub-teen double digits. All royalties are payable on a product-by-product and country-by-country basis until the later of the last-to-expire patent right covering the applicable product in the applicable country and a specified period of time from the first commercial sale of the applicable product in the applicable country.
Following FDA approval of VUMERITY, Biogen is now responsible for all development and commercialization activities for VUMERITY and all other products covered by the patents that the company licensed to Biogen.
Under the license and collaboration agreement, Biogen appointed the company as the toll manufacturer of clinical and commercial supplies of VUMERITY, subject to Biogen’s right to manufacture or has manufactured commercial supplies as a back-up manufacturer. In October 2019, it entered into a commercial supply agreement with Biogen for the commercial supply of VUMERITY, an amendment to such commercial supply agreement and an amendment to the license and collaboration agreement with Biogen, pursuant to which Biogen has conducted a technology transfer and, following an agreed manufacturing transition period, has elected to assume responsibility for the manufacture (itself or through a designee) of clinical and commercial supplies of VUMERITY in exchange for an increase in the royalty rate to be paid by Biogen to the company on net sales of product that is manufactured by Biogen or its designee. In May 2024, it completed the sale of research and development business and manufacturing facility in Athlone, Ireland (the “Athlone Facility”) where VUMERITY is manufactured. In connection with the sale of the Athlone Facility, it has entered into a subcontracting arrangement with the purchaser of the Athlone Facility for the manufacture of VUMERITY through the manufacturing transition period, which may continue through the end of 2025.
Proprietary Technology Platforms
The company has used its proprietary technology platforms, which include technologies owned and exclusively licensed to the company, to establish drug development, clinical development and regulatory expertise and in the development of the company’s products.
Injectable Extended-Release Microsphere Technology
The company’s injectable extended-release microsphere technology allows the company to encapsulate small-molecule pharmaceuticals, peptides and proteins in microspheres made of common medical polymers. The technology is designed to enable novel formulations of pharmaceuticals by providing controlled, extended release of drugs over time. Drug release from the microsphere is controlled by diffusion of the drug through the microsphere and by biodegradation of the polymer. These processes can be modulated through a number of formulation and fabrication variables, including drug substance and microsphere particle sizing and choice of polymers and excipients.
LinkeRx Technology
The company’s long-acting LinkeRx technology platform is designed to enable the creation of extended-release injectable versions of antipsychotic therapies and may also be useful in other disease areas in which extended duration of action may provide therapeutic benefits. The technology uses proprietary linker-tail chemistry to create new molecular entities derived from known agents.
NanoCrystal Technology
The company’s NanoCrystal technology is applicable to poorly water-soluble compounds and involves formulating and stabilizing drugs into particles that are nanometers in size. A drug in NanoCrystal form can be incorporated into a range of common dosage forms, including tablets, capsules, inhalation devices and sterile forms for injection, with the potential for enhanced oral bioavailability, increased therapeutic effectiveness, reduced/eliminated fed/fasted variability and sustained duration of intravenous/intramuscular release.
Oral Controlled Release Technology
The company’s oral controlled release (‘OCR’) technologies are used to formulate, develop and manufacture oral dosage forms of pharmaceutical products with varied drug release profiles.
Marketed Products
The company manufactures ARISTADA, ARISTADA INITIO, LYBALVI, VIVITROL, and microspheres for RISPERDAL CONSTA at the company’s Wilmington, Ohio facility. The company outsources its packaging operations for ARISTADA, ARISTADA INITIO, LYBALVI, and VIVITROL to third-party contractors. Janssen is responsible for packaging operations for RISPERDAL CONSTA. The company’s Wilmington, Ohio facility has been inspected by the U.S., European (including the UK Medicines and Healthcare products Regulatory Agency), Chinese, Japanese, Brazilian, Turkish, Russian, and Saudi Arabian regulatory authorities for compliance with required cGMP standards for continued commercial manufacturing.
The company has entered into subcontracting arrangements for the manufacture of several products in the Athlone Facility that are marketed by third parties, including VUMERITY. This facility has been inspected by regulatory authorities of numerous jurisdictions for compliance with required cGMP standards for continued commercial manufacturing.
Clinical Products
The company manufactures clinical supplies of injectable extended-release products and solid dosage form products at its Wilmington, Ohio facility. It has also contracted with third-party manufacturers to formulate certain products for clinical use.
Permits and Regulatory Approvals
The company holds various permits, registrations, approvals and/or licenses in respect of the company’s manufacturing and related activities. The primary licenses held in this regard are FDA Registrations of Drug Establishment, and licenses from the Drug Enforcement Administration of the U.S. Department of Justice (‘DEA’). The company also holds various authorizations, licenses and certificates from the Health Products Regulatory Authority in Ireland (‘HPRA’), including an Investigational Medicinal Products Manufacturers Authorization (No. IMP074/00002) and a Manufacturers Authorization (No. M13297/00001) in respect of the company’s offices located in Dublin, Ireland; and a Manufacturers Authorization (No. M13297/00002) in respect of the Athlone Facility, pending completion of updates to applicable product filings. The company also holds current GMP certificates associated with each of these authorizations. Due to certain U.S. state law requirements, it also holds state licenses to cover distribution activities conducted in certain states where required. Additional Manufacturer Authorizations that it previously held in respect of the Athlone Facility were transferred to Novo with the sale of the facility and related business in May 2024.
The company’s licensee usually holds the relevant marketing authorization from the FDA or other relevant regulatory authority, and the company supports this authorization as needed, including by furnishing a copy of the product’s Drug Master File, or chemistry, manufacturing, and controls data, to the relevant regulator. The company generally updates this information annually with the relevant regulator. In other cases where the company has developed proprietary products, such as VIVITROL, ARISTADA, ARISTADA INITIO, and LYBALVI, the company holds the marketing authorization and related regulatory documentation itself.
Marketing, Sales, and Distribution
The company is responsible for the marketing of VIVITROL, ARISTADA, ARISTADA INITIO, and LYBALVI in the U.S. The company focuses its sales and marketing efforts on physicians in private practice and in public treatment systems. The company uses customary pharmaceutical company practices to market the company’s products, including through advertisements, professional symposia, selling initiatives, and other methods, and to educate individual physicians, nurses, social workers, counselors, and other stakeholders involved in the treatment of opioid dependence, alcohol dependence, schizophrenia, and bipolar I disorder. The company provides, and contracts with third-party vendors to provide, customer services and other related programs for the company’s products, such as product-specific websites, insurance research services, and order, delivery and fulfillment services.
The company’s sales force for VIVITROL in the U.S. consists of approximately 105 individuals as of December 31, 2024. VIVITROL is primarily sold to pharmaceutical wholesalers, pharmacies, specialty distributors, and treatment providers. Product sales of VIVITROL during the year ended December 31, 2024, to McKesson Corporation, Cardinal Health, and Cencora, Inc. (formerly known as Amerisource Bergen, “Cencora”) represented approximately 34%, 21%, and 16%, respectively, of total VIVITROL gross sales.
The company’s sales force for ARISTADA, ARISTADA INITIO, and LYBALVI in the U.S. consists of approximately 355 individuals as of December 31, 2024. ARISTADA, ARISTADA INITIO, and LYBALVI are primarily sold to pharmaceutical wholesalers. Product sales of ARISTADA and ARISTADA INITIO during the year ended December 31, 2024, to McKesson Corporation, Cardinal Health, and Cencora represented approximately 38%, 32%, and 23%, respectively, of total ARISTADA and ARISTADA INITIO gross sales. Product sales of LYBALVI during the year ended December 31, 2024, to McKesson Corporation, Cardinal Health, and Cencora represented approximately 35%, 32%, and 29%, respectively, of total LYBALVI gross sales.
ICS, a division of AmerisourceBergen, provides warehousing, shipping and administrative services for VIVITROL, ARISTADA, ARISTADA INITIO, and LYBALVI.
Under the company’s license agreements with Janssen, Biogen, and other licensees and sublicensees, the licensees and sublicensees are typically responsible for the commercialization of any products developed under their respective agreements if and when regulatory approval is obtained.
Competition
In the treatment of schizophrenia, ARISTADA, the long-acting INVEGA products and RISPERDAL CONSTA compete with each other and a number of other injectable products, including ZYPREXA RELPREVV ((olanzapine) For Extended Release Injectable Suspension), which is marketed and sold by Lilly; ABILIFY MAINTENA (aripiprazole for extended release injectable suspension), a once-monthly injectable formulation of ABILIFY (aripiprazole) developed by Otsuka Pharm. Co.; ABILIFY ASIMTUFII (aripiprazole), a once-every-two months injectable formulation of ABILIFY (aripiprazole) developed by Otsuka Pharm. Co.; PERSERIS (risperidone for extended release injectable suspension), a once-monthly formulation of risperidone marketed by Indivior plc; RYKINDO (risperidone), a once-every-two-weeks injectable formulation of risperidone developed by Luye Pharma Group; UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, developed and marketed by MedinCell S.A. and Teva; and generic versions of branded injectable products.
In the treatment of schizophrenia, LYBALVI competes with other oral antipsychotic products, including CAPLYTA (lumateperone) developed and marketed by Intra-Cellular Therapies, Inc.; REXULTI (brexpiprazole), which is co-marketed by Otsuka Pharm Co. and H. Lundbeck A/S plc; VRAYLAR (cariprazine), which is marketed and sold by Abbvie Inc.; COBENFY (xanomeline and trospium chloride), which is marketed and sold by Bristol-Myers Squibb Company; other oral compounds currently on the market; and generic versions of branded oral products. Other pharmaceutical companies are developing products for the treatment of schizophrenia that, if approved by the FDA, would compete with LYBALVI.
In the treatment of bipolar I disorder, LYBALVI, and RISPERDAL CONSTA compete with antipsychotics, such as oral aripiprazole; VRAYLAR; ABILIFY MAINTENA; ABILIFY ASIMTUFII; CAPLYTA; RYKINDO; risperidone; quetiapine; olanzapine; and ziprasidone. Other pharmaceutical companies are developing products for the treatment of bipolar I disorder that, if approved by the FDA, would compete with LYBALVI.
In the treatment of alcohol dependence, VIVITROL competes with generic acamprosate calcium (also known as CAMPRAL) and generic disulfiram (also known as ANTABUSE), as well as currently marketed drugs, including generic drugs, also formulated from naltrexone.
In the treatment of opioid dependence, VIVITROL competes with SUBOXONE (buprenorphine HCl/naloxone HCl dehydrate sublingual tablets), SUBOXONE (buprenorphine/naloxone) Sublingual Film, SUBUTEX (buprenorphine HCl sublingual tablets), and SUBLOCADE (once-monthly buprenorphine extended-release injection), each of which is marketed and sold by Indivior plc; BUNAVAIL buccal film (buprenorphine and naloxone) marketed by BioDelivery Sciences; ZUBSOLV (buprenorphine and naloxone) marketed by Orexo US, Inc.; and BRIXADI (buprenorphine) extended-release injection for subcutaneous use (CIII), marketed by Braeburn Inc. VIVITROL also competes with methadone, oral naltrexone, and generic versions of SUBUTEX and SUBOXONE sublingual tablets.
In the treatment of MS, VUMERITY competes with AVONEX (interferon beta-1a), TYSABRI (natalizumab), TECFIDERA (dimethyl fumarate), and PLEGRIDY (peginterferon beta-1a) from Biogen; OCREVUS (ocrelizumab) from Genentech; BETASERON (interferon beta-1b) from Bayer HealthCare Pharmaceuticals; COPAXONE (glatiramer acetate) from Teva; REBIF (interferon beta-1a), and MAVENCLAD (cladribine) from EMD Serono, Inc.; GILENYA (fingolimod), EXTAVIA (interferon beta-1b), and MAYZENT (siponimod) from Novartis AG; AUBAGIO (teriflunomide) and LEMTRADA (alemtuzumab) from Sanofi-Aventis; ZEPOSIA (ozanimod) from Bristol-Myers Squibb Company; PONVORY (ponesimod) from Janssen; and BRIUMVI (ublituximab-xiiy) from TG Therapeutics, Inc.
Patents and Proprietary Rights
ARISTADA and ARISTADA INITIO
The company has several U.S. patents and patent applications, and a number of corresponding non-U.S. counterparts, that cover ARISTADA and/or ARISTADA INITIO.
VIVITROL
The company has a number of patents and pending patent applications covering its microsphere technology throughout the world, which, to some extent, cover VIVITROL.
The company owns one unexpired Orange-Book listed U.S. patent covering VIVITROL, which expires in the U.S. in 2029. Pursuant to the terms of a confidential settlement and license agreement entered into in August 2023 with Teva, the company granted Teva a non-exclusive, royalty-free, non-transferable, non-sublicensable limited license under the remaining patent covering VIVITROL to market and sell a generic version of VIVITROL in the U.S. beginning on January 15, 2027 (the ‘First Entry Date’), or earlier under certain circumstances. Under the terms of a settlement and license agreement entered into in July 2019 with Amneal Pharmaceuticals LLC (‘Amneal’), the company granted Amneal a non-exclusive license under certain patents covering VIVITROL, including the remaining patent covering VIVITROL in the U.S., to market and sell a generic formulation of VIVITROL in the U.S. beginning on the earlier of the First Entry Date, sometime in 2028 or earlier under certain circumstances.
INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI
The company’s NanoCrystal technology patent portfolio, licensed to Janssen, contains a number of granted patents and pending patent applications throughout the world, including in the U.S. and in countries outside of the U.S. The latest to expire of the patents subject to the company’s license agreement expires in 2030 in the U.S., the EU and certain other countries. In addition, Janssen has other patents not subject to the company’s license agreement, including one that covers INVEGA TRINZA in the U.S. and expires in 2036 and two that cover INVEGA HAFYERA in the U.S. and expire in 2041.
VUMERITY
The company has the U.S. patents and patent applications, and a number of corresponding non-U.S. counterparts, that cover VUMERITY. U.S. Patent Nos. 8,669,281, 9,090,558 and 10,080,733, each expiring in 2033, cover compositions of, or methods of the treatment for, VUMERITY.
LYBALVI
The company owns or has a license to the U.S. and worldwide patents and patent applications that cover a class of compounds that includes the opioid modulators in LYBALVI. In addition, the company owns the U.S. and worldwide patents and patent applications that claim formulations and methods of treatment that cover LYBALVI.
ALKS 2680
The company has the U.S. patent protection that extends to 2041, several U.S. patent applications, and a number of corresponding non-U.S. counterparts, that cover ALKS 2680.
The company’s trademarks, including VIVITROL, ARISTADA, ARISTADA INITIO, and LYBALVI, are important to it and are generally covered by trademark applications or registrations with the U.S. Patent and Trademark Office (the “USPTO”) and the patent or trademark offices of other countries. Its licensed products and products using its proprietary technologies also use trademarks that are owned by its licensees, such as the trademarks for INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA, INVEGA HAFYERA/BYANNLI, and RISPERDAL CONSTA, which are registered trademarks of Johnson & Johnson or its affiliated companies and VUMERITY, which is a registered trademark of Biogen (and used by it under license). Trademark protection varies in accordance with local law and continues in some countries as long as the trademark is used and in other countries as long as the trademark is registered. Trademark registrations generally are for fixed but renewable terms.
Regulatory
The company is subject to the U.S. Foreign Corrupt Practices Act (the ‘FCPA’) and its Irish equivalent, which prohibits corporations and their representatives from paying, offering to pay, promising, authorizing, or making payments of anything of value to any foreign government official, government staff member, political party, or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity.
The company is subject to a variety of financial disclosures, securities trading regulations and the U.S. and Irish or EU governmental regulations as an Irish-incorporated company publicly-listed in the U.S., including laws relating to the oversight activities of the SEC, the Irish Companies Act 2014, and the regulations of the Nasdaq Stock Market (‘Nasdaq’), on which the company’s shares are traded.
History
Alkermes plc was founded in 1987.
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