APOMORPHINE HYDROCHLORIDE | N210875 | SUMITOMO PHARMA AMERICA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from US WorldMeds, LLC FDA-2019-P-6049 · 29 docket documents US WorldMeds, LLC filed this section 505(q) citizen petition on December 23, 2019, requesting that the FDA require any abbreviated new drug application (ANDA) for a generic version of APOKYN (apomorphine hydrochloride injection) seek approval of both the drug and device constituent parts of the comb | 505(q) | 2019-12-30 | Denied | US WorldMeds, LLC |
Citizen Petition from US WorldMeds, LLC FDA-2015-P-2626 · 4 docket documents US WorldMeds, LLC, the licensee and exclusive distributor of APOKYN (apomorphine hydrochloride injection) for treating off-episodes in advanced Parkinson's disease, filed this citizen petition requesting that the FDA require all applicants seeking approval of apomorphine drug-device combination prod | 505(q) | 2015-07-24 | Denied | US WorldMeds, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8414922 | Dec 16, 2031 | — | — | Yes | — | |
| 8846074 | Dec 16, 2031 | — | — | Yes | — | |
| 9044475 | Jun 11, 2030 | — | — | Yes | — | — |
| 9283219 | Jun 11, 2030 | — | — | Yes | — | |
| 9326981 | Jun 11, 2030 | — | — | — | — | |
| 9669019 | Jun 11, 2030 | — | — | Yes | — | |
| 9669021 | Jun 11, 2030 | — | — | — | — | |
| 10420763 | Jun 11, 2030 | — | — | Yes | — | |
| 10449146 | Apr 19, 2036 | — | — | — | — | |
| 10821074 | Aug 7, 2029 | — | — | Yes | — | — |
| 10959943 | Apr 19, 2036 | — | — | — | — | |
| 11419769 | Dec 16, 2031 | — | — | Yes | — |