US protection ending in 2027: Pregnancy and women's health
As of the edition of 20 October 2026, 26 drugs have US protection that ends in 2027 in pregnancy and women's health; 16 of them have at least one company on route B because of it.
Sources: FDA Orange Book and Purple Book, other approval registers.
26 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Anakinra | Ends 2027 (orphan exclusivity) | Marketed | Swedish Orphan Biovitrum | IL1R1 | 0 |
| Artesunate | Ends 2027 (exclusivity) | Marketed | Amivas | 0 | |
| Bevacizumab | Ends 2027 (orphan exclusivity) | Marketed | Roche | VEGFA | 2 |
| Canakinumab | Ends 2027 (orphan exclusivity) | Marketed | Novartis | IL1B | 1 |
| Desvenlafaxine | Ends 2027 (patent) | Marketed | Pfizer | SLC6A4 | 0 |
| Edoxaban | Ends 2027 (patent) | Marketed | Daiichi Sankyo | F10 | 1 |
| Enzalutamide | Ends 2027 (patent) | Marketed | Astellas | AR | 1 |
| Ferric carboxymaltose | Ends 2027 (patent) | Marketed | American Regent | 0 | |
| Insulin degludec | Ends 2027 (computed from the first US licence) | Marketed | Novo Nordisk | INSR | 0 |
| Ipilimumab | Ends 2027 (orphan exclusivity) | Marketed | Bristol Myers Squibb | CTLA4 | 1 |
| Lenalidomide | Ends 2027 (patent) | Marketed | Bristol Myers Squibb | CRBN | 0 |
| Lonafarnib | Ends 2027 (exclusivity) | Marketed | Sentynl Therapeutics | FNTA, FNTB | 3 |
| Methylene blue cation | Ends 2027 (exclusivity) | Marketed | Provepharm | GUCY1A1, GUCY1A2, GUCY1B1 | 1 |
| Nintedanib | Ends 2027 (exclusivity) | Marketed | Boehringer Ingelheim | FGFR1, FGFR2, FGFR3 | 9 |
| Pantoprazole | Ends 2027 (exclusivity) | Marketed | Pfizer | ATP4A | 1 |
| Regadenoson anhydrous | Ends 2027 (patent) | Marketed | Astellas | ADORA2A | 2 |
| Rifaximin | Ends 2027 (patent) | Marketed | Bausch Health | 0 | |
| Sacubitril | Ends 2027 (patent) | Marketed | Novartis | MME | 1 |
| Saxagliptin anhydrous | Ends 2027 (exclusivity) | Marketed | AstraZeneca | DPP4 | 2 |
| Secnidazole | Ends 2027 (exclusivity) | Marketed | Neothetics | 0 | |
| Secukinumab | Ends 2027 (computed from the first US licence) | Marketed | Novartis | IL17A | 1 |
| Sorafenib | Ends 2027 (patent) | Marketed | Bayer | BRAF, FLT1, FLT3 | 1 |
| Telavancin | Ends 2027 (patent) | Marketed | Apotex | 0 | |
| Umeclidinium | Ends 2027 (patent) | Marketed | GSK | CHRM3 | 0 |
| Voclosporin | Ends 2027 (patent) | Marketed | Aurinia Pharmaceuticals | PPP3CA | 2 |
| Vorinostat | Ends 2027 (patent) | Marketed | Merck & Co. | HDAC1, HDAC2, HDAC3 | 4 |
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 2027 in pregnancy and women's health
In the product16 of these 26 drugs have at least one company on route B. Which companies, and their scores, are in the product.
Get this list with the companies, scores and sources as a fileRequest access. Nothing is shown until you do.