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Last Updated: February 28, 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
⤷  Try a Trial⤷  Try a Trial500MG/5ML(100MG/ML)INJECTABLE;INJECTION
⤷  Try a Trial⤷  Try a Trial200MG/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 022225-001 Dec 15, 2015 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 AP RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aspiro SUGAMMADEX SODIUM sugammadex sodium SOLUTION;INTRAVENOUS 214337-002 Jun 9, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms SUGAMMADEX SODIUM sugammadex sodium SOLUTION;INTRAVENOUS 214290-001 Oct 4, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for sugammadex sodium

Country Patent Number Title Estimated Expiration
Russian Federation 2260013 ПРОИЗВОДНЫЕ 6-МЕРКАПТОЦИКЛОДЕКСТРИНА: РЕВЕРСИРУЮЩИЕ АГЕНТЫ ДЛЯ ИНДУЦИРОВАННОЙ ЛЕКАРСТВЕННЫМ СРЕДСТВОМ НЕЙРОМЫШЕЧНОЙ БЛОКАДЫ (DERIVATIVES OF 6-MERCAPTOCYCLODEXTRIN: REVERSING AGENTS FOR DRUG- INDUCED NEUROMUSCULAR BLOCKADE) ⤷  Try a Trial
Czech Republic 298206 Deriváty 6-merkaptocyklodextrinu a farmaceutický prostredek (6-Mercaptocyclodextrin derivatives and pharmaceutical composition) ⤷  Try a Trial
Germany 60017947 ⤷  Try a Trial
Taiwan I242015 ⤷  Try a Trial
Japan 2006348301 6-MERCAPTO-CYCLODEXTRIN DERIVATIVE: REVERSAL AGENT FOR DRUG-INDUCED NEUROMUSCULAR BLOCK ⤷  Try a Trial
Norway 20022522 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 0140316 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sugammadex sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1259550 C01259550/01 Switzerland ⤷  Try a Trial FUSION; FORMER OWNER: ORGANON BIO SCIENCES NEDERLAND B.V., NL
1259550 CA 2009 00002 Denmark ⤷  Try a Trial PRODUCT NAME: SUGAMMADEX ELLER FARMACEUTISK AKTIVE SALTE ELLER ESTERE DERAF, HERUNDER SUGAMMADEXNATRIUM
1259550 SZ 47/2008 Austria ⤷  Try a Trial PRODUCT NAME: SUGAMMADEX; 6-PER-DEOXY-6-PER-(2-CARBOXYETHYL) THIO-Y-CYCLODEXTRIN UND PHARMAZEUTISCH VERTRÄGLICHES SALZ HIERVON
1259550 122008000068 Germany ⤷  Try a Trial PRODUCT NAME: SUGAMMADEX ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550 340 Finland ⤷  Try a Trial
1259550 SPC/GB08/057 United Kingdom ⤷  Try a Trial PRODUCT NAME: SUGAMMADEX; REGISTERED: UK EU/1/08/466/001 20080725; UK EU/1/08/466/002 20080725
1259550 08C0052 France ⤷  Try a Trial PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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