ANDA approvals-February 2026 and Astellas Pharma Inc. v. Ascent Pharmaceuticals, Inc.,

Contents

ANDA approvals-February 2026

General information

Generics suspect GSK of playing “divisional game” after EPO revocation

CDSCO issues advisory against promotion of prescription obesity drugs

Intellectual Property

Astellas Pharma Inc. v. Ascent Pharmaceuticals, Inc.,

ANDA approvals-February 2026

We follow ANDA approvals. In February 2026, the USFDA issued 91 ANDA approvals, of which 24 were tentative. A tentative approval is a formal notification from the USFDA indicating that a generic drug application has met all scientific and regulatory requirements for safety, efficacy, and quality, but cannot be granted final marketing approval due to unexpired patents or market exclusivities held by the original brand-name drug. The companies that could seek more than two ANDA approvals (including tentative ones) in February were as follows.

Some of our other comments about a few ANDA approvals sought by Indian companies are listed below.

General information

Generics suspect GSK of playing “divisional game” after EPO revocation

GlaxoSmithKline has suffered a defeat at the EPO in the dispute over its blockbuster Ellipta. The Boards of Appeal have revoked an important dosage patent. However, the US innovator is still protecting its drug with other patents from the same family. Generic drug companies accuse GSK of evergreening by playing the "divisional game". News here

CDSCO issues advisory against promotion of prescription obesity drugs

The Central Drugs Standard Control Organization (CDSCO) has issued an advisory cautioning pharmaceutical manufacturers, importers, and marketing authorisation holders against direct or indirect promotional activities related to prescription drugs indicated for obesity and metabolic disorders, including GLP-1 receptor agonists. The advisory, issued under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, reiterates that the manufacture, sale, distribution, and promotion of drug products must strictly comply with approved indications, labeling requirements, and other regulatory provisions. News here

Intellectual Property

Astellas Pharma Inc. v. Ascent Pharmaceuticals, Inc.,

Case background

• Plaintiffs: Astellas Pharma Inc. (API), Astellas Ireland Co., Ltd. (AICL), and Astellas Pharma Global Development, Inc. (APGD). Defendants: Ascent Pharmaceuticals, Inc., MSN Pharmaceuticals Inc., and MSN Laboratories Pvt. Ltd.
• This Hatch Waxman patent infringement action arose from Ascent’s ANDA No. 218172 seeking FDA approval to market a generic version of Myrbetriq (mirabegron extended release tablets) for overactive bladder (OAB).
• A bench trial occurred October 27–31, 2025. The Court issued findings of fact and conclusions of law on March 6, 2026

OB listed patents Asserted patents and claims

• Astellas asserted infringement of U.S. Patent Nos. 10,842,780 (’780), 11,707,451 (’451), 12,059,409 (’409), and 12,097,189 (’189) (the Asserted Patents). Expiration: September 28, 2029, with paediatric exclusivity extending to March 28, 2030.
• Asserted claims: composition claims (Claims 9, 13, 20 of the ’780; Claim 5 of the ’409) requiring specific mirabegron doses, excipients (polyethylene glycol and polyethylene oxide), and a defined dissolution profile (≤39% dissolution at 1.5 hours; ≥75% at 7 hours). Method claims (e.g., claims in the ’451 and ’189) requiring hydrogel forming formulations, continuous release ≥4 hours, and a reduced food effect relative to an immediate release comparator.

Claim construction and stipulated meanings The Court adopted prior claim constructions from related proceedings and issued constructions in this case:

• “Hydrogel forming polymer” and “means for forming a hydrogel” given plain and ordinary meanings (not limited to polyethylene oxide).
• “Reduced food effect” in the ’451 was construed as a clinically significant reduction in the percent reduction of Cmax and AUC in fed vs. fasted states for the sustained release formulation versus an immediate release comparator; in the ’189 it was defined as a ≥10% reduction in the rate of decrease of Cmax fed vs. fasted.
• “Immediate Release Formulation” was defined as the immediate release formulation of Comparative Example 1.

Infringement ruling

• Astellas proved infringement by a preponderance of the evidence. The Court found Ascent’s ANDA products met the asserted claim limitations.
• The Court entered findings that Ascent’s ANDA submission infringes the listed claims of the ’780, ’451, ’409, and ’189 patents and that commercial manufacture/use/sale prior to patent expiration would likewise infringe, including inducement and contributory infringement theories.

Invalidity defences (Ascent’s challenges) Section 101 (patent eligibility): The Court rejected Ascent’s § 101 challenges. Composition claims were held to be directed to non-natural man-made compositions (drug + excipients + non-natural dissolution behaviour), and method claims were directed to specific treatment methods for specific patients using specific compounds and doses, thus not directed to laws of nature or natural phenomena. Section 102 (anticipation): Ascent asserted U.S. Patent No. 6,699,503 (the ’503 patent) anticipated various claims. The Court found the ’503 patent did not disclose every claim limitation (notably mirabegron, specific doses, treatment of OAB, or the claimed reduced food effect profile); thus, Ascent failed to show anticipation by clear and convincing evidence. Section 103 (obviousness): The court’s decision hinged largely on Ascent’s failure to prove by clear and convincing evidence that Astellas's sustained-release mirabegron formulation was obvious. Ascent argued that the invention was a predictable combination of known elements, relying on several prior art references, including the '503 Patent, Takasu '540, and the OCAS technology described by Chapple and Michel. However, the court found several critical gaps in this "obvious to combine" theory: Unpredictability of Food Effects: At the priority date, a Person of Ordinary Skill in the Art (POSA) would not have known that mirabegron exhibited a "food effect" (changes in absorption when taken with a meal) in its immediate-release form. Because food effects are highly drug-specific and impossible to predict without clinical studies, a POSA would have had no motivation to design a formulation specifically to solve a problem they didn't know existed. Discouragement by Prior Art: Mirabegron has a long half-life of approximately 24 hours. The court noted that a POSA would have seen this as a reason to stick with once-daily immediate-release dosing rather than pursuing a complex sustained-release system. Furthermore, mirabegron is a BCS Class III drug with better absorption in the upper intestine; prior art suggested that sustained-release formulations (which release in the lower GI tract) might actually perform poorly for such drugs. Hindsight Bias: The court rejected Ascent's reliance on the '503 Patent as a primary reference. While Astellas later listed the '503 Patent in the Orange Book for Myrbetriq, this occurred years after the priority dates. The court ruled that using this later listing to select the '503 Patent as a starting point for an obviousness challenge was a classic example of hindsight bias working backward from the known success of the invention. Section 112 (written description): Ascent alleged a lack of written description for the ’451 and ’189 patents (free base vs. dihydrochloride salt). The Court found the common specification clearly conveyed possession of the mirabegron free base (“Compound A”), so written description challenges failed. Conclusion Because the claimed invention required solving an unknown problem (the food effect) using a delivery system that prior art suggested might be unnecessary or ineffective for this specific molecule, the court concluded the inventive step was valid. Consequently, the court ordered that the FDA cannot approve Ascent’s generic product until the patents and their pediatric exclusivity expire on March 28, 2030. Decision here