Tris Pharma, Inc. filed Tris Pharma, Inc. v. Granules Pharmaceuticals, Inc., No. 1:26-cv-01160 (D. Del.), on September 15, 2026. The Hatch-Waxman complaint targets Granules's ANDA No. 220284 for generic versions of DYANAVEL XR (amphetamine) 5 mg, 10 mg, 15 mg, and 20 mg extended-release tablets, which Tris markets under NDA No. 210526 for ADHD.

Patents and accused products

The complaint asserts U.S. Patent 12,734,132 (Extended release amphetamine tablets), issued September 15, 2026 and assigned to Tris. Count I alleges infringement of one or more claims; the pleading does not list specific claim numbers. The accused product is Granules's Proposed ANDA Product under ANDA No. 220284. Tris pleads that Granules earlier sent a March 11, 2025 notice letter tied to Orange Book-listed U.S. Patent 11,590,081 for the same ANDA, and that the parties already litigate that ANDA in related Delaware case No. 25-498. Because the '132 patent issued after the ANDA filing, the complaint does not plead a Paragraph IV notice or 30-month stay clock for the '132 itself.

What the patents cover

U.S. Patent 12,734,132 covers oral amphetamine extended-release solid doses that combine an uncoated amphetamine-cation exchange resin complex, a barrier-coated amphetamine-cation exchange resin complex-matrix, and uncomplexed amphetamine, including blends of amphetamine forms. The patent describes reaching a therapeutically effective amphetamine amount by about one hour after a single dose, with at least about thirteen hours of post-dose effect. Asserted claims: one or more claims (numbers not specified in the complaint).

Illustrative Claim 1 (not a complaint-specified asserted list) covers a once-daily morning ADHD treatment method for patients not younger than 6 years using oral amphetamine solid dosage forms that include (A) d- and l-amphetamine complexed with a cation exchange resin in a 3.2 to 1 ratio, (B) amphetamine aspartate, and (C) dextroamphetamine sulfate, with about 60% to 80% w/w immediate-release and about 20% to 40% w/w modified-release amphetamines, and friability under about 1%. See U.S. Patent 12,734,132.

What the lawsuit is about

Tris alleges that Granules's ANDA filing under 35 U.S.C. § 271(e)(2) constitutes statutory infringement of one or more '132 claims, that the Proposed ANDA Product uses an extended-release formulation covered by the patent, and that commercial manufacture, sale, or importation after final ANDA approval would infringe, induce, and/or contribute to infringement. Tris seeks to delay FDA approval until patent expiry (plus any other exclusivity) and permanent injunctive relief. The complaint notes FDA has granted tentative approval to ANDA No. 220284 and that final approval has not yet issued.

What it means

This is a Delaware Hatch-Waxman follow-on for the same DYANAVEL XR tablet ANDA already in No. 25-498, now adding a same-day-issued formulation patent. Expect coordination with the related case, disputes over whether the newly issued '132 can support § 271(e)(2) liability without a dedicated Paragraph IV notice, and claim-scope fights over resin-complex / IR-MR blend limitations once Tris identifies specific claims.

What to watch next

Watch Granules's answer, any early invalidity or noninfringement contentions, and whether the court coordinates or consolidates this case with Tris Pharma v. Granules, No. 25-498 (D. Del.). Also watch Orange Book listing of the '132 patent for NDA No. 210526 and any later claim-narrowing or preliminary-injunction practice.