SUGAMMADEX SODIUM | N022225 | MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2025-01-23 | Terminated 2025-09-04 | — | |
MERCK SHARP & DOHME B.V. et al v. HIKMA PHARMACEUTICALS USA INC. 2 patentsANDA 218727sugammadex | D.N.J. | 2024-03-15 | Terminated 2025-09-16 | — |
MERCK SHARP & DOHME B.V. et al v. TEVA PHARMACEUTICALS USA, INC. et al 2 patentsANDA 214126sugammadex | D.N.J. | 2020-12-14 | Terminated 2021-02-02 | — |
Merck Sharp & Dohme B.V. et al v. Mylan Pharmaceuticals Inc. et al 2 patentsANDA 213915sugammadex | WVND | 2020-04-02 | Terminated 2022-08-08 | — |
MERCK SHARP & DOHME B.V. et al v. MSN LABORATORIES PRIVATE LIMITED et al 2 patentsANDA 214368sugammadex | D.N.J. | 2020-03-26 | Terminated 2020-08-24 | — |
| D.N.J. | 2020-03-12 | Terminated 2020-08-24 | — | |
| D.N.J. | 2020-03-10 | Terminated 2023-06-29 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 HIGHLIGHTS OF PRESCRIBING INFORMATION BRIDION re Suitability Pet... FDA-2023-P-3411 Hyman, Phelps & McNamara, P.C. filed a petition regarding Bridion (sugammadex) to address suitability concerns, requesting FDA review of the drug's prescribing information and regulatory status. The petition involves an approved NDA product and seeks clarification or modification of the labeling or | Suitability | 2023-08-10 | Open | Hyman |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2023-P-3411 The law firm Hyman, Phelps & McNamara, P.C., on behalf of an unnamed client, filed a suitability petition under FDC Act Section 505(j)(2)(C) and 21 C.F.R. § 314.93 requesting that the FDA declare Sugammadex Injection, 100 mg/mL in a single-dose prefilled syringe suitable for submission as an ANDA, c | Suitability | 2023-08-10 | Open | Hyman |
Suitability Petition Lachman Consulting Services, Inc. FDA-2022-P-1153 Lachman Consulting Services, Inc. submitted a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Sugammadex Injection 1000 mg/10 mL (100 mg/mL) suitable for submission as an ANDA based on the reference listed drug BRIDION | Suitability | 2022-06-14 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| RE44733 | Jan 27, 2026PED: Jul 27, 2026 | PED | Yes | Yes | — |
| Code | Date | Status |
|---|---|---|
| NPP | Dec 12, 2027 | Active |
| PED | Jun 12, 2028 | Active |