PEGFILGRASTIM | B125031 | AMGEN
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Jan. 31, 2002 — 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 | Nov. 13, 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 11865177(formulation)· AI-discovered, not Purple-Book-listed · relevance 65/100. This caps practical skinny-label entry; it does not move the licensure floor above.
30 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 18 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12350480 | Other | Jul. 3, 2045Active | Discovered |
| 12325737 | Other | Jun. 5, 2045Active | Discovered |
| 12274736 | Method-of-use (carveable) | Apr. 10, 2045Active | Discovered |
| 11945839 | Other | Mar. 28, 2044Active | Discovered |
| 11944798 | Other | Mar. 28, 2044Active | Discovered |
| 11912823 | Other | Feb. 22, 2044Active | Discovered |
| 11865177 | Formulation/compound | Jan. 4, 2044Active | Discovered |
| 11576856 | Other | Feb. 9, 2043Active | Discovered |
| 11419990 | Other | Aug. 18, 2042Active | Discovered |
| 11407794 | Formulation/compound | Aug. 4, 2042Active | Discovered |
| 11229683 | Method-of-use (carveable) | Jan. 20, 2042Active | Discovered |
| 11034793 | Other | Jun. 10, 2041Active | Discovered |
| 10941182 | Formulation/compound | Mar. 4, 2041Active | Discovered |
| 10933141 | Formulation/compound | Feb. 25, 2041Active | Discovered |
| 10806795 | Formulation/compound | Oct. 15, 2040Active | Discovered |
Showing 15 of 51 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 123 AI-discovered patents by relevance.
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2021-00326 | 9856287 | IPR | Lupin, Ltd. et al. | Institution Denied | 2020-12-15 | — |
| IPR2020-00314 | 9856287 | IPR | Fresenius Kabi USA, LLC et al. | Terminated-Settled | 2019-12-20 | — |
| IPR2019-00971 | 9856287 | IPR | Fresenius Kabi USA, LLC et al. | Institution Denied | 2019-04-14 | — |
| PGR2019-00001 | 9856287 | PGR | Adello Biologics, LLC | Terminated-Settled | 2018-10-01 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Amgen Inc. et al v. Hospira, Inc. et al 1 patentpegfilgrastim (recombinantly expressed, 175-amino acid form of human granulocyte-colony stimulating factor conjugated to 20 kD monomethoxypolyethylene glycol) | D. Del. | 2020-02-11 | Terminated 2022-03-21 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.