Posts

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 ...
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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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FDA 505(b)(2) Breakthroughs: Sun Pharma Depot, Baxter RTU, and Landmark Norwich v. Kennedy Exclusivity Ruling

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Summary of the blog post: 2-minute read.  API & IP Intelligence Roundup (07 September 2026) The latest regulatory intelligence highlights vital lifecycle formulation innovations via the USFDA 505(b)(2) pathway, strategic corporate realignments, and a precedential D.C. Circuit ruling overturning FDA's interpretation of 180-day generic exclusivity forfeiture . 1. Recent 505(b)(2) NDA Approvals & Filings (August 2026) The 505(b)(2) pathway continues to deliver differentiated clinical value, de-risking development by building on established reference molecules : Baxter Healthcare (Sodium Bicarbonate Injection, USP — NDA 218524): Approved in ready-to-administer (RTA) Viaflo plastic containers ( 150 mEq/1,000mL ) . This factory-standardised, isotonic continuous-infusion presentation eliminates manual cleanroom compounding from hypertonic 8.4% vials under USP <797>, reducing the risk of bedside calculation errors and acute hypernatremia in intensive care units . ...
Location: Mumbai, Maharashtra, India
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