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Indian Pharma Captures 57% of USFDA ANDAs, Medicare Pricing Lawsuit, & Delhi HC Precedent in ZARA v. ZORA

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 Summary of the blog post- 5-minute read.  1. Indian Pharma Leads September 2026 USFDA ANDA Approvals. The USFDA granted 56 ANDA approvals (49 final, 7 tentative) in September 2026, with Indian generic manufacturers capturing 32 approvals (over 57% of the total) . Indian developers demonstrated strong technical capability across complex solid oral oncology, cardiovascular therapies, and CNS indications : Sacubitril and Valsartan Tablets (Aurobindo): Targets Novartis's blockbuster heart failure franchise Entresto ($4.5B US peak sales) . Launch timing remains tied to resolution of secondary polymorph and combination patent litigation, alongside multi-filer generic competition from Torrent, Lupin, and MSN . Pomalidomide Capsules (MSN): Final approval referencing Celgene/BMS’s Pomalyst ($2.2B US peak sales) for relapsed/refractory multiple myeloma, governed by confidential settlement agreements establishing staggered, volume-limited entry . Ibrutinib Capsules (Hetero Labs...
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September 2026 505(b)(2) Approvals Breakdown, Vanda v. Teva Non-Infringement Victory, & Sanofi’s $8B Mega-Deal

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Summary of the blog: 5-minute read API & IP Intelligence Roundup (05 October 2026) This edition evaluates the latest wave of 505(b)(2) NDA approvals addressing unmet clinical needs across multi-billion-dollar oncology, metabolic, and cardiovascular markets, landmark pharmaceutical deals, and a critical Delaware Federal Court ruling applying the Supreme Court’s Hikma precedent to insulate generic tasimelteon from late-stage continuation patent claims . 1. September 2026 505(b)(2) NDA Approvals & Tentative Approvals The FDA granted final and tentative approvals to five differentiated 505(b)(2) formulations that bypass reference-product administration hurdles or innovator patent thickets : OMCAZIO (Cabozantinib Laurylsulfate, NDA #220613 – Handa Oncology LLC): Final Approval for oral capsules (11.5 mg, 23 mg, 34.5 mg) referencing Cabometyx (~$1.4B US sales) . Formulated as a novel laurylsulfate salt with enhanced oral bioavailability that can be taken with or without food...
Location: Mumbai, Maharashtra, India
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