TRASTUZUMAB AND HYALURONIDASE-OYSK | B761106 | GENENTECH INC
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Feb. 28, 2019 — 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 12331134(composition)· AI-discovered, not Purple-Book-listed · relevance 88/100. This caps practical skinny-label entry; it does not move the licensure floor above.
30 formulation/compound (cap skinny entry) · 17 method-of-use (carveable — gate nothing) · 3 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12331134 | Formulation/compound | Jun. 12, 2045Active | Discovered |
| 12281153 | Method-of-use (carveable) | Apr. 17, 2045Active | Discovered |
| 12252549 | Formulation/compound | Mar. 13, 2045Active | Discovered |
| 12173080 | Other | Dec. 19, 2044Active | Discovered |
| 12128103 | Method-of-use (carveable) | Oct. 24, 2044Active | Discovered |
| 12110341 | Formulation/compound | Oct. 3, 2044Active | Discovered |
| 11992529 | Method-of-use (carveable) | May. 23, 2044Active | Discovered |
| 11787873 | Formulation/compound | Oct. 12, 2043Active | Discovered |
| 11655305 | Method-of-use (carveable) | May. 18, 2043Active | Discovered |
| 11638756 | Method-of-use (carveable) | Apr. 27, 2043Active | Discovered |
| 11597776 | Formulation/compound | Mar. 2, 2043Active | Discovered |
| 11414498 | Formulation/compound | Aug. 11, 2042Active | Discovered |
| 11406715 | Method-of-use (carveable) | Aug. 4, 2042Active | Discovered |
| 11077189 | Method-of-use (carveable) | Jul. 29, 2041Active | Discovered |
| 10898570 | Method-of-use (carveable) | Jan. 21, 2041Active | Discovered |
Showing 15 of 50 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.
Top 50 of 243 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
The Trustees of the University of Pennsylvania v. Genentech, Inc. 2 patentstrastuzumab, pertuzumab | D. Del. | 2022-01-31 | Terminated 2025-03-14 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.