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 |
|---|---|---|---|---|---|---|
| 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 | — |
| IPR2020-00314 | 9856287 | IPR | Fresenius Kabi USA, LLC et al. | Terminated-Settled | 2019-12-20 | — |
| IPR2021-00326 | 9856287 | IPR | Lupin, Ltd. et al. | Institution Denied | 2020-12-15 | — |
| 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).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Apotex, Inc. FDA-2017-P-2803 Apotex Inc. and its subsidiary Apobiologix filed this citizen petition under 21 U.S.C. §355(q) requesting that the FDA require all biosimilar applicants referencing NEULASTA (pegfilgrastim) to conduct comparative clinical efficacy studies, including pharmacokinetic, pharmacodynamic, and immunogenici | 505(q) Stay Request | 2017-05-04 | Denied | Apotex |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.