USFDA July 2026 ANDA Approvals: Indian Pharma Dominance, Antidiabetic Waves, US Tariffs, & EPO Patent Insights
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Summary: USFDA ANDAs & Global Pharma IP Roundup
The US generic landscape in July 2026 saw rapid momentum across complex generics, notable patent expiries, and supply-chain realignments
1. July 2026 USFDA ANDA Approvals: Key Trends
The USFDA granted 46 final approvals and 6 tentative approvals (TAs) across global manufacturers
Indian Generic Pharma Dominance: Indian drugmakers captured 46% of all regulatory decisions (20 final approvals, 4 TAs)
. Aurobindo led with 3 approvals (Etodolac, Bupropion, Adapalene/Benzoyl Peroxide), followed by Macleods (Chlorthalidone, Dapsone), Zydus (Fluvoxamine, Edaravone), and Laurus Labs (Rilpivirine, TAF) . Antidiabetic Wave in Tentative Approvals: Five of the six tentative approvals focused on blockbuster antidiabetic agents facing near-term patent expirations, including Sitagliptin/Metformin (Ajanta Pharma), Sitagliptin (Dr. Reddy’s), Linagliptin (Apotex), and Canagliflozin (Teva)
. High-Value & Complex Generic Highlights:
Respiratory & Oncology: Nintedanib / Nintedanib Esylate Capsules (Ofev® generics) approved for Glenmark and Humanwell Puracap
. Direct Oral Anticoagulants (DOACs): Rivaroxaban Tablets (Xarelto® generic across all 4 dosage strengths) secured by Mankind Pharma
. Antiretrovirals: Rilpivirine Hydrochloride Tablets (Edurant® generic) cleared for Laurus Labs
. CNS & Controlled Substances: Final approvals for Alprazolam (Unichem) and Diazepam (Lupin)
. Critical Care Injectables: Propofol (Anthea Pharma) and Ephedrine Sulfate (Baxter)
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2. Global Supply Chains: US Tariffs & The China-India Dynamic
Measuring US Reshoring Realities: Following announcements of US generic drug tariffs aimed at encouraging domestic drug production, supply chain analysts emphasize monitoring tangible metrics—such as active plant groundbreakings and validated capital expenditures—rather than corporate press releases
. Upstream China Dependency: While Indian pharma manufactures nearly 40% of US generic finished dosage forms, its reliance on Chinese Key Starting Materials (KSMs) and APIs means diversifying the American medicine cabinet requires long-term infrastructure investment
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3. Intellectual Property: EPO Revokes Transglutaminase Patent (T 0324/24)
The EPO Technical Board of Appeal 3.3.08 revoked European Patent No. 3 447 137 (Kinry Food Ingredients / Kinry Biotech) following an appeal by opponent International N&H Denmark ApS (IFF / DuPont Nutrition Biosciences)
Unallowable Undisclosed Disclaimer (Art. 123(2) EPC): Kinry’s attempt to introduce an undisclosed disclaimer to bypass a prior doctoral dissertation (D1) failed
. Under G 1/03, because D1 operated in the same field of protein cross-linking for human use, it was not an accidental anticipation . Lack of Inventive Step (Art. 56 EPC): Adjusting formulation pH from 8.0 to 5.0–7.5 did not demonstrate a tangible improvement in room-temperature storage stability, representing routine workshop optimisation
. Late-Filed Submissions Barred (Art. 13(2) RPBA 2020): Kinry’s last-minute switch from product to method claims before oral hearings was rejected for lack of exceptional circumstances
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Contents
ANDA approvals-July 2026
General information
What Are the Specific Metrics to Look for Following the Tariff Announcement?
America’s Medicine Cabinet Has a China Problem: Can India Replace Beijing?
Intellectual Property
EPO Technical Board of Appeal Decision T 0324/24 (Liquid Enzyme Preparation / KINRY)
ANDA approvals-July 2026
- Sitagliptin + Metformin combinations: Ajanta Pharma (2 TAs)
- Sitagliptin single agent: Dr. Reddy's Laboratories (1 TA)
- Linagliptin: Apotex (1 TA)
- Canagliflozin: Teva Pharms USA (1 TA)
- Respiratory / Tyrosine Kinase: Nintedanib / Nintedanib Esylate capsules (Ofev generics) secured by Glenmark and Humanwell Puracap.
- Direct Oral Anticoagulant (DOAC): Rivaroxaban tablets (Xarelto generic) secured by Mankind Pharma.
- Peptide / GLP-1: Liraglutide injection approved for Sandoz.
- Antiretrovirals: Rilpivirine Hydrochloride (Laurus Labs) and Tenofovir Alafenamide Fumarate (TAF) TA (Laurus Labs).
- CNS & Controlled Substances: Final approvals for Alprazolam (Unichem), Diazepam (Lupin), Brivaracetam (ScieGen, Shandong), and Pitolisant (Novitium).
General information
What Are the Specific Metrics to Look for Following the Tariff Announcement?
America’s Medicine Cabinet Has a China Problem: Can India Replace Beijing?
Intellectual Property
EPO Technical Board of Appeal Decision T 0324/24 (Liquid Enzyme Preparation / KINRY)
- The Claim: Claim 1 defined a liquid transglutaminase preparation characterised by specific pH (5.0-9.0), water activity(Aw< 0.89), and redox potential (-400mV to +50 mV), with an undisclosed disclaimer excluding a specific transglutaminase solution disclosed in document D1 (a 2010 doctoral dissertation on gelatin nanoparticles).
- The Ruling: Under G 1/03, an undisclosed disclaimer to restore novelty over an accidental disclosure is only allowable if the prior art is so unrelated and remote from the claimed invention that the skilled person would never have considered it.
- The Board found that both D1 and the patent address liquid transglutaminase preparations used for protein cross-linking for human consumption/application. Because D1 operated in the same technical field, it was not an accidental anticipation. The lack of focus on long-term storage stability in D1 did not make it "technically unrelated". Consequently, the disclaimer added subject-matter contrary to Article 123(2) EPC.
- The Claim: Deleted the disclaimer and narrowed the pH range to 5.0-7.5.
- Starting Point & Technical Effect: The Board rejected the proprietor’s argument that D1 was an "unsuitable" starting point merely because it did not explicitly aim to solve room-temperature storage stability. The inventive step can be assessed starting from any legitimate state of the art on file.
- The only distinguishing feature between claim 1 and D1 (which operated at pH 8.0) was the pH range (5.0-7.5 vs 8.0).
- The Board found that the patent’s comparative data failed to demonstrate an enhanced technical effect (storage stability) across the claimed composition versus D1. In the absence of an established technical effect, the objective technical problem was merely the provision of an alternative liquid enzyme preparation. Adjusting the pH from 8.0 to 7.5 represented an arbitrary, routine workshop modification lacking inventive step.
- Further narrowed water activity (0.6-0.85) and redox potential (-400 mV to 0 mV).
- Experimental data on file (D1b) established that the D1 formulation exhibited an Aw of 0.801 and a redox potential of -37.9 mV, directly falling within the claimed ranges. It was held obvious for the same reasons as Auxiliary Request I.
- Late Claim Request: After receiving the Board's preliminary opinion, the proprietors submitted Auxiliary Request III (deleting all product claims to retain only a preparation method) along with documents D33–D38 and experimental report D39.
- The Ruling: The Board did not admit the amendments filed after the summons, as no exceptional circumstances were justified by cogent reasons. Following decision T 1800/21, the Board confirmed that deleting claims constitutes an amendment to the appeal case. Because the method claim had not been substantively addressed in the written appeal proceedings, admitting it would necessitate an entirely new discussion contrary to procedural economy and fairness.
- Documents D33–D39 were also rejected as no exceptional circumstances or detailed substantiations were provided.
- The appellant/opponent requested an apportionment of costs, arguing that the proprietor's unsubstantiated filing of nearly 100 pages of late technical documents (D33–D39) forced them into unnecessary analysis and preparation.
- The Ruling: The Board held that an order for costs on equitable grounds requires culpable misconduct causing unreasonable costs. Because the late filings were clearly deficient and unlikely to meet the stringent requirements for submissions, a cursory review was sufficient for the appellant. An in-depth, burdensome review was not legally mandated, and the request was accordingly refused.
- The decision under appeal is set aside.
- European Patent No. 3 447 137 is revoked.
- The request for apportionment of costs is rejected.
