FILGRASTIM | B103353 | AMGEN
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Feb. 20, 1991 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Open now | Open now | no live licensure floor |
| Full-label entry | Mar. 30, 2022 | Passed | no live block |
Best-skinny equals full-label — no carveable orphan block runs past the licensure floor.
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 12246059(formulation)· AI-discovered, not Purple-Book-listed · relevance 88/100. This caps practical skinny-label entry; it does not move the licensure floor above.
24 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 23 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12371728 | Other | Jul. 24, 2045Active | Discovered |
| 12312381 | Other | May. 22, 2045Active | Discovered |
| 12246059 | Formulation/compound | Mar. 6, 2045Active | Discovered |
| 12195779 | Other | Jan. 9, 2045Active | Discovered |
| 12098211 | Other | Sep. 19, 2044Active | Discovered |
| 11944798 | Other | Mar. 28, 2044Active | Discovered |
| 11945837 | Other | Mar. 28, 2044Active | Discovered |
| 11865177 | Formulation/compound | Jan. 4, 2044Active | Discovered |
| 11813310 | Formulation/compound | Nov. 9, 2043Active | Discovered |
| 11786866 | Other | Oct. 12, 2043Active | Discovered |
| 11299539 | Other | Apr. 7, 2042Active | Discovered |
| 11020537 | Other | May. 27, 2041Active | Discovered |
| 10946070 | Formulation/compound | Mar. 11, 2041Active | Discovered |
| 10933141 | Formulation/compound | Feb. 25, 2041Active | Discovered |
| 10822630 | Other | Oct. 29, 2040Active | Discovered |
Showing 15 of 50 patents (latest expirations).
Approved Biosimilars
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 101 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2020-04-24 | Terminated 2021-09-08 | — | |
| S.D. Cal. | 2019-07-23 | Terminated 2019-12-20 | — | |
| N.D. Cal. | 2019-02-21 | Terminated 2019-05-14 | — | |
| D. Del. | 2018-07-18 | Terminated 2021-09-08 | — | |
| D.N.J. | 2018-03-08 | Terminated 2019-11-25 | — | |
| N.D. Cal. | 2014-10-24 | Terminated 2018-01-08 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.