CYSTEINE HYDROCHLORIDE | N210660 | EXELA PHARMA SCIENCES LLC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| PGR2020-00064 | 10478453 | PGR | Eton Pharmaceuticals, Inc. | Institution Denied | 2020-05-19 | — |
| PGR2020-00068 | 10583155 | PGR | Eton Pharmaceuticals Inc. | Institution Denied | 2020-06-08 | — |
| PGR2020-00086 | 10653719 | PGR | Eton Pharmaceuticals, Inc. | Institution Denied | 2020-09-21 | — |
| PGR2024-00016 | 11642370 | PGR | Nexus Pharmaceuticals LLC | Institution Denied | 2024-02-08 | 2024-08-08 |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Exela Pharma Sciences, LLC v. Hikma Pharmaceuticals USA Inc. 2 patentsANDA 213073L-cysteine hydrochloride | D. Del. | 2023-02-06 | Terminated 2023-06-30 | — |
| D. Del. | 2020-05-14 | Terminated 2020-08-07 | — | |
| D. Del. | 2020-03-16 | Terminated 2022-09-02 | — | |
| D. Del. | 2020-01-07 | Terminated 2020-07-08 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lachman Consultant Services, Inc FDA-2018-P-1808 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Cysteine Hydrochloride Injection 5% containing 34.6 mg/mL of Cysteine base suitable for submission as an ANDA under Section 505(j)(2)(C), with the reference-listed drug being Cysteine Hydrochl | Other | 2018-05-09 | Open | Lachman Consultant Services, Inc |
Regulus Pharmaceutical Consulting, Inc. - Citizen Petition FDA-2008-P-0278 · 5 docket documents Regulus Pharmaceutical Consulting, Inc. filed this citizen petition on behalf of a client requesting that the FDA determine whether Hospira's Cysteine Hydrochloride Injection USP 7.25% (NDA 19-523) was withdrawn from the market for safety or effectiveness reasons, and if not, to accept an ANDA for a | 505(q) | 2008-05-02 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 10478453 | Jan 15, 2039 | — | — | Yes | — | |
| 10583155 | Jan 15, 2039 | — | — | Yes | — | |
| 10653719 | Jan 15, 2039 | — | — | Yes | — | — |
| 10905713 | Jan 15, 2039 | — | — | Yes | — | — |
| 10905714 | Jan 15, 2039 | — | — | Yes | — | — |
| 10912795 | Jan 15, 2039 | — | — | Yes | — | — |
| 10918662 | Jan 15, 2039 | — | — | Yes | — | — |
| 10933089 | Jan 15, 2039 | — | — | Yes | — | — |
| 11510941 | Jan 15, 2039 | — | — | Yes | — | — |
| 11510942 | Jan 15, 2039 | — | — | Yes | — | |
| 11642370 | Jan 15, 2039 | — | — | Yes | — | — |
| 11648262 | Jan 15, 2039 | — | — | Yes | — | — |
| 11679125 | Jan 15, 2039 | — | — | Yes | — | — |
| 11684636 | Jan 15, 2039 | — | — | Yes | — | — |
| 11826383 | Jan 15, 2039 | — | — | Yes | — | — |
| 11969439 | Jan 15, 2039 | — | — | — | — |