FILGRASTIM | B103353 | AMGEN
Regulatory Exclusivities
| Type | Expiry | Status | Source |
|---|---|---|---|
| 7-Year Orphan | Mar. 30, 2022 | Expired | Purple Book |
Purple Book Patents
No listed patents in Purple Book.
Estimated Patent LOE
Based on latest discovered patent 12371728(manufacturing) · relevance 65/100
Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.
Top 50 of 101 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2020-04-24 | Terminated 2021-09-08 | — | |
| CASD | 2019-07-23 | Terminated 2019-12-20 | — | |
| CAND | 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 | — | |
| CAND | 2014-10-24 | Terminated 2018-01-08 | — |
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.