Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant | B125126 | Merck Sharp & Dohme LLC
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Jun. 8, 2006 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
Marketing-entry ceiling (litigation risk)
Patents do not gate FDA licensure of a biosimilar — FDA licenses biosimilars (full or carved label) without adjudicating any patent. These are a practical marketing-entry ceiling resolved in the § 262(l) patent dance and ordinary litigation. A formulation/compound patent caps practical skinny entry via litigation (Regeneron v. Mylan); a method-of-use patent is carveable and gates nothing.
Latest formulation/compound patent 11717567(composition)· AI-discovered, not Purple-Book-listed · relevance 80/100. This caps practical skinny-label entry; it does not move the licensure floor above.
18 formulation/compound (cap skinny entry) · 0 method-of-use (carveable — gate nothing) · 7 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 11717567 | Formulation/compound | Aug. 3, 2043Active | Discovered |
| 11638754 | Formulation/compound | Apr. 27, 2043Active | Discovered |
| 11406706 | Formulation/compound | Aug. 4, 2042Active | Discovered |
| 11220668 | Formulation/compound | Jan. 6, 2042Active | Discovered |
| 10821175 | Formulation/compound | Oct. 29, 2040Active | Discovered |
| 10772947 | Formulation/compound | Sep. 10, 2040Active | Discovered |
| 10429129 | Formulation/compound | Sep. 26, 2039Active | Discovered |
| 10369217 | Formulation/compound | Aug. 1, 2039Active | Discovered |
| 10286058 | Formulation/compound | May. 9, 2039Active | Discovered |
| 10111952 | Formulation/compound | Oct. 25, 2038Active | Discovered |
| 9808521 | Formulation/compound | Nov. 2, 2037Active | Discovered |
| 9573811 | Formulation/compound | Feb. 16, 2037Active | Discovered |
| 9457087 | Formulation/compound | Sep. 29, 2036Active | Discovered |
| 9388394 | Formulation/compound | Jul. 7, 2036Active | Discovered |
| 8445227 | Other | May. 16, 2033Active | Discovered |
Showing 15 of 25 patents (latest expirations).
Disclaimer: Identifying an available carve-out is not a prediction that FDA will approve the particular carved label, nor that marketing it is free of infringement risk. For biologics, availability turns on exclusivities, not patents: FDA licenses a biosimilar (full or carved label) without adjudicating any patent, and patent disputes run through the § 262(l) patent dance and ordinary litigation, outside this availability view.
25 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.