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 | N.D. W. Va. | 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 |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2023-P-3411 · 6 docket documents 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 | Granted | Hyman, Phelps & McNamara, P.C. |
Suitability Petition Lachman Consulting Services, Inc. FDA-2022-P-1153 · 5 docket documents 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 |