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SUGAMMADEX SODIUM

ANDA

SUGAMMADEX SODIUM | A214337 | ASPIRO PHARMA LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: BRIDION(TE code: AP)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
MERCK SHARP & DOHME B.V. et al v. ASPIRO PHARMA LIMITED 2:2020cv03112 2 patentsANDA 214337sugammadex	D.N.J.	2020-03-20	Terminated 2020-08-24	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain27 active DMFs3 inactive

27 active API suppliers hold Drug Master Files for this ingredient.

MATRIX PHARMACORP PRIVATE LTDSUGAMMADEX SODIUM

DMF 323112018

DR REDDYS LABORATORIES LTDSUGAMMADEX SODIUM

DMF 326142018

MSN LIFE SCIENCES PRIVATE LTDSUGAMMADEX SODIUM

DMF 337232019

NEULAND LABORATORIES LTDSUGAMMADEX SODIUM

DMF 337472019

RUYUAN HEC PHARM CO LTDSUGAMMADEX SODIUM NON STERILE BULK DRUG SUBSTANCE

DMF 337902019

LEK PHARMACEUTICALS DDSUGAMMADEX SODIUM

DMF 338172019

MANKIND PHARMA LTDSUGAMMADEX SODIUM

DMF 338642019

MEDICHEM MANUFACTURING (MALTA) LTDSUGAMMADEX SODIUM

DMF 338742019

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDSUGAMMADEX SODIUM (NON-STERILE, API)

DMF 339042019

NATCO PHARMA LTDSUGAMMADEX SODIUM

DMF 339212019

TAPI NL BVSUGAMMADEX SODIUM

DMF 339242019

USV PRIVATE LTDSUGAMMADEX SODIUM

DMF 340522019

APITORIA PHARMA PRIVATE LTDSUGAMMADEX SODIUM

DMF 340862019

HONOUR LAB LTDSUGAMMADEX SODIUM

DMF 341132019

BIOPHORE INDIA PHARMACEUTICALS PVT LTDSUGAMMADEX SODIUM

DMF 341702019

GLAND PHARMA LTDSUGAMMADEX SODIUM

DMF 342332019

SOLARA ACTIVE PHARMA SCIENCES LTDSUGAMMADEX SODIUM

DMF 344282019

WAVELENGTH ENTERPRISES LTDSUGAMMADEX SODIUM

DMF 351452020

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDSUGAMMADEX SODIUM

DMF 351512020

FARMHISPANIA SASUGAMMADEX SODIUM

DMF 353192020

CHANGZHOU PHARMACEUTICAL FACTORYSUGAMMADEX SODIUM

DMF 370852022

ASOLUTION PHARMACEUTICALS PVT LTDSUGAMMADEX SODIUM

DMF 374552022

HEFEI BOSIKC PHARMTECH CO LTDSUGAMMADEX SODIUM

DMF 375582022

SUZHOU RYWAY BIOTECH CO LTDSUGAMMADEX SODIUM

DMF 391352023

SICHUAN QINGMU PHARMACEUTICAL CO LTDSUGAMMADEX SODIUM

DMF 401582024

ALMELO PRIVATE LTDSUGAMMADEX SODIUM

DMF 411602025

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDSUGAMMADEX SODIUM NON-STERILE DRUG SUBSTANCE

DMF 424332025

FRESENIUS KABI ONCOLOGY LTDInactiveSUGAMMADEX SODIUM

DMF 338702019

SCINOPHARM TAIWAN LTDInactiveSUGAMMADEX SODIUM

DMF 339902019

EXTROVIS AGInactiveSUGAMMADEX SODIUM

DMF 351932020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 13, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jun 9, 2023

No patent or exclusivity listings for this strength.

#002 — EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jun 9, 2023