US protection

US protection ending in 2031: Immune system

As of the edition of 20 October 2026, 40 drugs have US protection that ends in 2031 in immune system; 27 of them have at least one company on route B because of it.

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

40 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Abemaciclib Ends 2031 (patent)Marketed Eli Lilly CDK4, CDK6 2
Alectinib Ends 2031 (patent)Marketed Roche ALK, RET 1
Benralizumab Ends 2031 (orphan exclusivity)Marketed AstraZeneca IL5RA 0
Bimatoprost Ends 2031 (patent)Marketed AbbVie PTGFR 3
Blinatumomab Ends 2031 (orphan exclusivity)Marketed Amgen CD19, CD3D, CD3E 0
Bosutinib Ends 2031 (exclusivity)Marketed Pfizer ABL1 1
Cabotegravir Ends 2031 (patent)Marketed GSK 0
Chimeric yellow fever dengue virus, live attenuated Ends 2031 (reference-product exclusivity)Marketed Sanofi 0
Daclatasvir Ends 2031 (patent)Marketed Bristol Myers Squibb 0
Delgocitinib Ends 2031 (patent)Marketed LEO Pharma JAK1, JAK2, JAK3 4
Dolutegravir Ends 2031 (patent)Marketed GSK 0
Dupilumab Ends 2031 (orphan exclusivity)Marketed Regeneron IL4R 1
Durvalumab Ends 2031 (orphan exclusivity)Marketed AstraZeneca CD274 1
Elbasvir Ends 2031 (patent)Marketed Merck & Co. 0
Ensifentrine Ends 2031 (patent)Marketed Merck & Co. PDE3A, PDE3B, PDE4A 4
Fostamatinib Ends 2031 (patent)Marketed Rigel Pharmaceuticals SYK 3
Iberdomide Ends 2031 (exclusivity)Marketed Bristol Myers Squibb CRBN, CUL4A, DDB1 0
Imetelstat sodium Ends 2031 (exclusivity)Marketed Geron TERT 1
Inotuzumab ozogamicin Ends 2031 (orphan exclusivity)Marketed Pfizer CD22 0
Letermovir Ends 2031 (exclusivity)Marketed Merck & Co. 0
Letrozole Ends 2031 (patent)Marketed Novartis CYP19A1 1
Levacetylleucine Ends 2031 (exclusivity)Marketed IntraBio F9 1
Luspatercept Ends 2031 (computed from the first US licence)Marketed Bristol Myers Squibb TGFB1, TGFB2, TGFB3 3
Mavorixafor Ends 2031 (exclusivity)Marketed X4 Pharmaceuticals CXCR4 2
Niraparib Ends 2031 (patent)Marketed GSK PARP1, PARP2 6
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
Pretomanid Ends 2031 (exclusivity)Marketed Viatris 0
Ribociclib Ends 2031 (patent)Marketed Novartis CDK4, CDK6 2
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
Tovorafenib Ends 2031 (patent)Marketed Servier ARAF, BRAF, RAF1 6
Trastuzumab deruxtecan Ends 2031 (computed from the first US licence)Marketed Daiichi Sankyo ERBB2, TOP1 3
Trifarotene Ends 2031 (patent)Marketed Galderma RARG 2

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 immune system

In the product

27 of these 40 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.

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.