US protection

US protection ending in 2032: Urinary and reproductive

As of the edition of 20 October 2026, 35 drugs have US protection that ends in 2032 in urinary and reproductive; 22 of them have at least one company on route B because of it.

Sources: FDA Orange Book and Purple Book, other approval registers.

35 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Avutometinib Ends 2032 (exclusivity)Marketed Verastem MAP2K1, MAP2K2 1
Baricitinib Ends 2032 (patent)Marketed Eli Lilly JAK1, JAK2 4
Belantamab mafodotin Ends 2032 (computed from the first US licence)Marketed GSK TNFRSF17, TUBB, TUBB1 8
Cabozantinib Ends 2032 (exclusivity)Marketed Exelixis KDR 2
Capmatinib Ends 2032 (patent)Marketed Novartis MET 1
Cobicistat Ends 2032 (patent)Marketed Gilead Sciences 0
Copanlisib Ends 2032 (patent)Marketed Bayer PIK3CA, PIK3CD 2
Dacomitinib anhydrous Ends 2032 (patent)Marketed Pfizer EGFR 1
Dasabuvir Ends 2032 (patent)Marketed AbbVie 0
Difelikefalin Ends 2032 (patent)Marketed CSL Behring OPRK1 2
Doravirine Ends 2032 (patent)Marketed Merck & Co. 0
Dordaviprone Ends 2032 (exclusivity)Marketed Chimerix CLPP, DRD2 2
Eculizumab Ends 2032 (orphan exclusivity)Marketed AstraZeneca C5 0
Elamipretide Ends 2032 (exclusivity)Marketed Stealth BioTherapeutics 0
Emtricitabine Ends 2032 (patent)Marketed Gilead Sciences 0
Eptinezumab Ends 2032 (computed from the first US licence)Marketed Lundbeck CALCA, CALCB 2
Estradiol Ends 2032 (patent)Marketed ESR1 6
Golimumab Ends 2032 (orphan exclusivity)Marketed Johnson & Johnson TNF 0
Isatuximab Ends 2032 (computed from the first US licence)Marketed Sanofi CD38 1
Margetuximab Ends 2032 (computed from the first US licence)Marketed MacroGenics ERBB2 1
Naloxegol Ends 2032 (patent)Marketed Averitas Pharma OPRM1 3
Nerandomilast Ends 2032 (exclusivity)Marketed Boehringer Ingelheim PDE4B 1
Nilotinib Ends 2032 (patent)Marketed Novartis ABL1 0
Ombitasvir Ends 2032 (patent)Marketed AbbVie 0
Osimertinib Ends 2032 (patent)Marketed AstraZeneca EGFR 0
Plazomicin Ends 2032 (patent)Marketed Cipla 0
Regorafenib Ends 2032 (patent)Marketed Bayer BRAF, FGFR1, FGFR2 8
Sacituzumab govitecan Ends 2032 (computed from the first US licence)Marketed Gilead Sciences TACSTD2, TOP1 2
Selumetinib Ends 2032 (exclusivity)Marketed AstraZeneca MAP2K1, MAP2K2 4
Setmelanotide Ends 2032 (patent)Marketed Rhythm Pharmaceuticals MC4R 1
Somapacitan Ends 2032 (computed from the first US licence)Marketed Novo Nordisk GHR 1
Tafasitamab Ends 2032 (computed from the first US licence)Marketed Incyte CD19 1
Tenofovir alafenamide Ends 2032 (patent)Marketed Gilead Sciences 0
Treosulfan Ends 2032 (exclusivity)Marketed Medexus Pharma 0
Venetoclax Ends 2032 (patent)Marketed AbbVie BCL2 1

Listed by name. A route B row is one company at one target; for a drug with one target that is the number of companies. US protection is the US only, and it is not the date generics or biosimilars can enter.

Which companies are on route B in 2032 in urinary and reproductive

In the product

22 of these 35 drugs have at least one company on route B. Which companies, and their scores, are in the product.

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US protection movers, once a month

The drugs that entered or left the two-year window in the latest edition. An email, not an account: it gives no access to the product.