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1.) FDA First Generics Breakdown 2.) EPO Revokes Nubeqa: Darolutamide Generic Launch in Europe: How EPO Revocation of EP 3 250 554 Opens a 10-Month Commercial Window

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Quick summary- 5 minutes read. API & IP Intelligence Roundup (28 September 2026) This edition evaluates the commercial dynamics of the FDA's 91 "First Generic" approvals, key corporate legal developments including Novartis's dismissal of purchaser antitrust litigation on Entresto, Lantheus's radiopharmaceutical nod, and an EPO Board of Appeal decision revoking Orion Corporation’s darolutamide polymorph patent, unlocking a valuable generic window in Europe . 1. FDA First Generic Drug Approvals: Commodity Cliffs vs. High-Barrier Niches The FDA CDER list highlights 91 inaugural generic clearances, illustrating two distinct market dynamics : Rapid Generic Erosion in Small Molecules: Highly contested patent cliffs saw immediate crowding from multiple sponsors . The primary example is Rivaroxaban tablets (2.5 mg), where over 10 global and Indian generic filers (including Lupin, Dr. Reddy's, Alembic, Biocon, Macleods, and Alkem) gained approvals against th...
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Paragraph IV Targets on Dayvigo & Lumify PF, CAFC Shields Vifor's Injectafer from $100M+ Claim, & Global IP Moves

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API & IP Intelligence Roundup (21 September 2026) This edition highlights pivotal Hatch-Waxman Paragraph IV patent challenges against high-value insomnia and OTC eye-care franchises, critical commercial regulatory approvals in speciality injectables, and a decisive Federal Circuit ruling establishing strict boundaries for chemical process patents in Biofer v. Vifor . 1. New Paragraph IV Challenges: First-in-Line Targets on Dayvigo & Lumify PF The USFDA's updated Paragraph IV list recorded two notable first-time challenges initiating the race for 180-day generic marketing exclusivity : Lemborexant Oral Tablets (Dayvigo):  After Eisai's 5-year New Chemical Entity (NCE) exclusivity expired, the inaugural Paragraph IV ANDA was filed on July 14, 2026 . Targeting the expanding dual orexin receptor antagonist (DORA) market (~$150M–$200M US; ~$500M globally), the generic filer is challenging core molecule, polymorph, and dosing regimen patents extending into 2034–2036 to ...
Location: Mumbai, Maharashtra, India
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August 2026 Generic Approvals Breakdown: Blockbuster Clearances for Pomalidomide, Cabozantinib, and Nintedanib

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Summary of this blog- 5-minute read API & IP Intelligence Roundup (14 September 2026) This edition covers the USFDA's August 2026 ANDA approval surge, global respiratory and emergency health updates, and a critical Federal Circuit patent precedent defining the enforceability of crystalline genus claims in Exelixis v. MSN . 1. USFDA ANDA Trends: Indian Generic Dominance & Multi-Product Openings The FDA recorded 54 ANDA regulatory decisions in August 2026 (43 final approvals, 11 tentative approvals) . Indian manufacturers demonstrated commanding leadership by capturing 33 of the 54 total decisions (61.1%) , led by multi-product approvals for Aurobindo, Zydus Lifesciences, Dr. Reddy's Laboratories, and Macleods : Oncology Wave: A coordinated cluster of final approvals on August 31 for Pomalidomide capsules across Cipla, Dr. Reddy’s, Sun Pharma (SPIL), and Sandoz cleared long-standing Paragraph IV settlements referencing Pomalyst® (~$3.5B peak global sales) . Specia...
Location: Mumbai, Maharashtra, India
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