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Last Updated: November 8, 2024

Sugammadex sodium - Generic Drug Details


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What are the generic drug sources for sugammadex sodium and what is the scope of patent protection?

Sugammadex sodium is the generic ingredient in two branded drugs marketed by Msd Sub Merck, Aspiro, and Zydus Pharms, and is included in three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Sugammadex sodium has forty-two patent family members in thirty countries.

There are two drug master file entries for sugammadex sodium. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for sugammadex sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Korea University Ansan HospitalPhase 4
YingHsuanTaiN/A
Zhejiang Cancer HospitalN/A

See all sugammadex sodium clinical trials

Generic filers with tentative approvals for SUGAMMADEX SODIUM
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up500MG/5ML(100MG/ML)INJECTABLE;INJECTION
⤷  Sign Up⤷  Sign Up200MG/2ML(100MG/ML)INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for sugammadex sodium
Anatomical Therapeutic Chemical (ATC) Classes for sugammadex sodium
Paragraph IV (Patent) Challenges for SUGAMMADEX SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BRIDION Injection sugammadex sodium 200 mg/2 mL and 500 mg/5 mL 022225 14 2019-12-16

US Patents and Regulatory Information for sugammadex sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 AP RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Aspiro SUGAMMADEX SODIUM sugammadex sodium SOLUTION;INTRAVENOUS 214337-002 Jun 9, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms SUGAMMADEX SODIUM sugammadex sodium SOLUTION;INTRAVENOUS 214290-001 Oct 4, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aspiro SUGAMMADEX SODIUM sugammadex sodium SOLUTION;INTRAVENOUS 214337-001 Jun 9, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for sugammadex sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for sugammadex sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1259550 91501 Luxembourg ⤷  Sign Up 91501, EXPIRES: 20230725
1259550 340 Finland ⤷  Sign Up
1259550 47/2008 Austria ⤷  Sign Up PRODUCT NAME: SUGAMMADEX; 6-PER-DEOXY-6-PER-(2-CARBOXYETHYL) THIO-Y-CYCLODEXTRIN UND PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550 SPC/GB08/057 United Kingdom ⤷  Sign Up PRODUCT NAME: SUGAMMADEX; REGISTERED: UK EU/1/08/466/001 20080725; UK EU/1/08/466/002 20080725
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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