aibioAlkermes sues Teva, Apotex and MSN over proposed generic Lybalvi
Tickers ALKS
Two Alkermes subsidiaries filed Hatch-Waxman patent suits in New Jersey and Delaware against Teva Pharmaceuticals, Apotex and MSN entities. FDA approval of each generic application is stayed for up to 30 months.
Key facts
- Company
- Alkermes plc (NASDAQ: ALKS)
- News type
- Legal
- Primary source
- Alkermes 10-Q for the quarter ended June 30, 2026 (SEC EDGAR)
Alkermes plc (Nasdaq: ALKS) disclosed in its 10-Q filed July 28, 2026 that two wholly owned subsidiaries are suing three groups of generic drug makers for patent infringement over proposed copies of Lybalvi, the company's olanzapine and samidorphan tablet. The plaintiffs are Alkermes Pharma Ireland Limited (APIL) and Alkermes, Inc. The cases were filed in the U.S. District Court for the District of New Jersey and, for one defendant, also in the U.S. District Court for the District of Delaware. The 10-Q gives no case numbers.
The defendants are Teva Pharmaceuticals, Inc.; Apotex Inc. and Apotex Corp.; and MSN Laboratories Private Limited, MSN Pharmaceuticals, Inc. and Novadoz Pharmaceuticals LLC. Because Alkermes' subsidiaries are the plaintiffs, the filings name no Alkermes executive or director as a defendant.
The case
APIL and Alkermes, Inc. sued Teva in New Jersey in August 2025. They sued Apotex in both New Jersey and Delaware the same month, and sued MSN in New Jersey in September 2025. On June 18, 2026, they filed a further New Jersey suit against Apotex. It was consolidated on July 23, 2026 with the previously filed lawsuit in the New Jersey court.
Each suit followed a "paragraph IV certification" notice from Teva, Apotex or MSN Labs. The 10-K explains that such a certification says a listed patent is invalid or will not be infringed by the applicant's product. The notices said each company had filed an abbreviated new drug application (ANDA) with the FDA to make, use or sell a generic Lybalvi in the 5mg/10mg, 10mg/10mg, 15mg/10mg and 20mg/10mg strengths before certain Alkermes U.S. patents expire. They also alleged that certain Lybalvi patents are invalid, unenforceable or will not be infringed. The company's 10-K filed February 25, 2026 says the patents the notices challenged have expiration dates between 2032 and 2041. Neither filing describes the specific relief Alkermes asks the courts to order.
Defendants
Teva Pharmaceuticals, Inc. (Teva) is sued in New Jersey. Apotex Inc. and Apotex Corp. (together Apotex) are sued in New Jersey and Delaware. MSN Laboratories Private Limited (MSN Labs), MSN Pharmaceuticals, Inc. and Novadoz Pharmaceuticals LLC (together MSN) are sued in New Jersey. The filings name no individual defendants.
Where it stands
Under the Hatch-Waxman Act, filing each suit within 45 days of receiving the matching notice triggered a stay of FDA approval of that generic application for up to 30 months. The 10-Q reports no trial date, ruling or settlement in any of the Lybalvi cases. Alkermes says it "intends to vigorously defend its intellectual property."
Why it matters to shareholders
The 10-Q says that at June 30, 2026, there were no potential material losses from claims or legal proceedings that the company determined were probable. For claims that are reasonably possible, it says no estimable loss or range of loss can be made. The filings give no damages figure for these cases. Each stay lasts up to 30 months, and the 10-Q does not say when any of them began or ends.
Related matters
The same note describes a putative antitrust class action over Vivitrol that Value Drug Company filed against Alkermes, Inc. and APIL in the District of Massachusetts. It also says Alkermes has received a civil investigative demand from a U.S. state governmental authority and is cooperating. Finally, it reports that on July 15, 2026, the Second Circuit affirmed a lower court decision in Alkermes' favor in Acorda Therapeutics, Inc.'s challenge to an arbitral award, in which Acorda had sought an additional approximately $66.0 million in damages.