US protection

US protection ending in 2031: Heart and blood vessels

As of the edition of 20 October 2026, 33 drugs have US protection that ends in 2031 in heart and blood vessels; 22 of them have at least one company on route B because of it.

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

33 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Abemaciclib Ends 2031 (patent)Marketed Eli Lilly CDK4, CDK6 2
Benralizumab Ends 2031 (orphan exclusivity)Marketed AstraZeneca IL5RA 0
Blinatumomab Ends 2031 (orphan exclusivity)Marketed Amgen CD19, CD3D, CD3E 0
Bosutinib Ends 2031 (exclusivity)Marketed Pfizer ABL1 1
Brolucizumab Ends 2031 (computed from the first US licence)Marketed Novartis VEGFA 0
Caplacizumab Ends 2031 (computed from the first US licence)Marketed Ablynx VWF 1
Cipepofol Ends 2031 (exclusivity)Marketed Haisco-USA Pharmaceuticals 0
Dolutegravir Ends 2031 (patent)Marketed GSK 0
Durvalumab Ends 2031 (orphan exclusivity)Marketed AstraZeneca CD274 1
Elafibranor Ends 2031 (exclusivity)Marketed Ipsen PPARA, PPARD 2
Elbasvir Ends 2031 (patent)Marketed Merck & Co. 0
Ertugliflozin Ends 2031 (patent)Marketed Merck & Co. SLC5A2 1
Iberdomide Ends 2031 (exclusivity)Marketed Bristol Myers Squibb CRBN, CUL4A, DDB1 0
Imetelstat sodium Ends 2031 (exclusivity)Marketed Geron TERT 1
Letermovir Ends 2031 (exclusivity)Marketed Merck & Co. 0
Levacetylleucine Ends 2031 (exclusivity)Marketed IntraBio F9 1
Lutetium oxodotreotide Ends 2031 (exclusivity)Marketed Advanced Accelerator Applications SSTR1, SSTR2, SSTR3 10
Macitentan Ends 2031 (exclusivity)Marketed Johnson & Johnson EDNRA, EDNRB 0
Maralixibat Ends 2031 (exclusivity)Marketed Mirum Pharmaceuticals SLC10A2 2
Mavorixafor Ends 2031 (exclusivity)Marketed X4 Pharmaceuticals CXCR4 2
Nitrous acid Ends 2031 (patent)Marketed Hope Biosciences 0
Nivolumab Ends 2031 (orphan exclusivity)Marketed Bristol Myers Squibb PDCD1 2
Pembrolizumab Ends 2031 (orphan exclusivity)Marketed Merck & Co. PDCD1 1
Polatuzumab vedotin Ends 2031 (computed from the first US licence)Marketed Roche CD79B, TUBB, TUBB1 1
Pomalidomide Ends 2031 (patent)Marketed Bristol Myers Squibb CRBN 0
Risankizumab Ends 2031 (computed from the first US licence)Marketed AbbVie IL23A 1
Romosozumab Ends 2031 (computed from the first US licence)Marketed Amgen SOST 2
Rucaparib Ends 2031 (patent)Marketed pharmaand PARP1, PARP2, PARP3 5
Sparsentan Ends 2031 (exclusivity)Marketed Retrophin AGTR1 2
Talazoparib Ends 2031 (patent)Marketed Pfizer PARP1, PARP2 2
Telotristat ethyl Ends 2031 (patent)Marketed TerSera Therapeutics TPH1, TPH2 4
Trastuzumab deruxtecan Ends 2031 (computed from the first US licence)Marketed Daiichi Sankyo ERBB2, TOP1 3
Vortioxetine Ends 2031 (patent)Marketed Takeda HTR1A, HTR3A, SLC6A4 5

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 2031 in heart and blood vessels

In the product

22 of these 33 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.