PEGFILGRASTIM | B125031 | AMGEN
Regulatory Exclusivities
| Type | Expiry | Status | Source |
|---|---|---|---|
| 12-Year BPCIA | Dec. 23, 2026 | Active | Computed |
| 7-Year Orphan | Nov. 13, 2022 | Expired | Purple Book |
Purple Book Patents (1)
| Patent | Expiration | Status |
|---|---|---|
| 9856287 | Jun. 21, 2030 | Active |
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.