aibioAytu BioPharma's Adzenys patent suit against Granules heads to a January 2027 trial
Tickers AYTU
Aytu (Nasdaq: AYTU) is the plaintiff against Granules Pharmaceuticals in Delaware, with trial moved to January 12, 2027. It is also a nominal plaintiff in a Section 16(b) suit against Armistice, now on appeal.
Key facts
- Company
- Aytu BioPharma, Inc. (NASDAQ: AYTU)
- News type
- Legal
- Primary source
- Aytu BioPharma 10-K for the year ended June 30, 2026 (SEC EDGAR)
Aytu BioPharma (Nasdaq: AYTU) disclosed in its 10-K filed September 22, 2026 that trial in its patent infringement lawsuit against Granules Pharmaceuticals, Inc. has moved from December 7, 2026 to January 12, 2027. The case is in the U.S. District Court for the District of Delaware and concerns Granules' plan to sell a generic version of Aytu's ADHD drug Adzenys. The 10-K gives no case number.
Granules Pharmaceuticals, Inc. is the defendant. The 10-K also describes a second matter, Revive Investing, LLC. et al v. Armistice Master Fund, Ltd. et al, Case 1:20-cv-02849-CMA-TPO, in which Aytu is a nominal plaintiff and Armistice Capital Master Fund, Ltd is a defendant. The plaintiffs have appealed to the U.S. Court of Appeals for the Tenth Circuit after a jury found no liability.
The case
On October 31, 2024, Aytu received a Paragraph IV certification notice letter from Granules. The letter said Granules intends to market a generic version of Adzenys before the expiration of all patents listed in the FDA's Orange Book, and that its New Drug Application contains a certification alleging those patents are not valid, not enforceable or will not be infringed.
Aytu sued Granules on December 11, 2024. Filing suit triggered a stay that bars the FDA from approving Granules' application for up to 30 months, or until a judgment finds the patents invalid, unenforceable or not infringed, whichever comes first. Granules answered the complaint on January 7, 2025.
In Revive Investing, two shareholders sued Armistice, contending it was liable under Section 16(b) of the Securities Exchange Act of 1934 for short swing trading profits on trades it made in Aytu stock in 2019 and 2020, and that it must disgorge those profits to Aytu. The case is in the U.S. District Court for the District of Colorado.
Defendants
Granules Pharmaceuticals, Inc. is the only defendant named in the Adzenys patent case. In Revive Investing, the caption names Armistice Master Fund, Ltd. and others, and the 10-K describes the defendant as Armistice Capital Master Fund, Ltd. The 10-K names no individual defendants in either case.
Where it stands
The Granules case is ongoing. Trial was originally scheduled to begin on December 7, 2026 and is now set for January 12, 2027. Aytu says it plans to vigorously enforce its intellectual property rights related to Adzenys.
In Revive Investing, a jury returned a verdict finding no liability on January 29, 2025. The plaintiffs filed an appeal in the Tenth Circuit on March 6, 2025. The 10-K reports no ruling on the appeal.
Why it matters to shareholders
Aytu says the one remaining unexpired composition-of-matter patent for Adzenys is scheduled to expire in 2032. Under a 2017 settlement, Actavis Laboratories FL, Inc., now owned by Teva Pharmaceutical Industries Limited, had the right to market its generic Adzenys beginning September 1, 2025, and launched in December 2025. Aytu also warns that generic competition can take a significant share of a branded product's sales and could hurt its revenue, profitability and cash flows. For fiscal 2026 Aytu recorded net revenue of $57.6 million.
Aytu says the Revive Investing case, whatever its outcome, will not have a materially adverse effect on its financial condition, results of operations or cash flows. The 10-K does not give a loss estimate for the Granules case. It adds that, apart from the matters it describes, no pending legal proceedings are believed likely to have a materially adverse effect on Aytu's financial condition, results of operations or cash flows.