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Last Updated: November 27, 2022

Sugammadex sodium - Generic Drug Details


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

Sugammadex sodium is the generic ingredient in one branded drug marketed by Organon Sub Merck and is included in one NDA. 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. One supplier is 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
YingHsuanTaiN/A
Zhejiang Cancer HospitalN/A
Ministry of Food and Drug Safety, KoreaPhase 2

See all sugammadex sodium clinical trials

Generic filers with tentative approvals for SUGAMMADEX SODIUM
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 500MG BASE/5ML (EQ 100MG BASE/ML)SOLUTION;INTRAVENOUS

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
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
Organon Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Organon Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
Organon Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 See Plans and Pricing See Plans and Pricing
Organon Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 See Plans and Pricing See Plans and Pricing
Organon Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 See Plans and Pricing See Plans and Pricing
Organon Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 See Plans and Pricing See Plans and Pricing
Organon Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 See Plans and Pricing See Plans and Pricing
Organon Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for sugammadex sodium

Country Patent Number Title Estimated Expiration
Japan 2003515623 See Plans and Pricing
Canada 2390463 DERIVES DE 6-MERCAPTO-CYCLODEXTRINE: AGENTS D'INVERSION DU BLOCAGE NEUROMUSCULAIRE PROVOQUE PAR DES SUBSTANCES MEDICAMENTEUSES (6-MERCAPTO-CYCLODEXTRIN DERIVATIVES: REVERSAL AGENTS FOR DRUG-INDUCED NEUROMUSCULAR BLOCK) See Plans and Pricing
Netherlands 300356 See Plans and Pricing
Poland 203012 See Plans and Pricing
China 1188428 See Plans and Pricing
Germany 60017947 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sugammadex sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1259550 SPC/GB08/057 United Kingdom See Plans and Pricing PRODUCT NAME: SUGAMMADEX; REGISTERED: UK EU/1/08/466/001 20080725; UK EU/1/08/466/002 20080725
1259550 47/2008 Austria See Plans and Pricing 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 08C0052 France See Plans and Pricing PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550 SPC031/2008 Ireland See Plans and Pricing SPC031/2008: 20090428, EXPIRES: 20230724
1259550 340 Finland See Plans and Pricing
1259550 C01259550/01 Switzerland See Plans and Pricing FUSION; FORMER OWNER: ORGANON BIO SCIENCES NEDERLAND B.V., NL
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
Moodys
AstraZeneca
Baxter
McKesson

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