Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Express Scripts
AstraZeneca
McKesson
Johnson and Johnson

Last Updated: June 27, 2022

Sugammadex sodium - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

What are the generic drug 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
Ministry of Food and Drug Safety, KoreaPhase 2
Seoul National University HospitalPhase 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
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
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 022225-001 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 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 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
>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 022225-002 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 022225-002 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
Austria 288450 See Plans and Pricing
Mexico PA02004940 DERIVADOS DE 6-MERCAPTO-CICLODEXTRIN: AGENTES DE REVERTIMIENTO PARA BLOQUEO NEUROMUSCULAR INDUCIDO POR FARMACOS. (6 MERCAPTO CYCLODEXTRIN DERIVATIVES: REVERSAL AGENTS FOR DRUG INDUCED NEUROMUSCULAR BLOCK.) See Plans and Pricing
Czech Republic 20021814 See Plans and Pricing
Brazil 0015947 See Plans and Pricing
Norway 20022522 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 CA 2009 00002 Denmark See Plans and Pricing PRODUCT NAME: SUGAMMADEX ELLER FARMACEUTISK AKTIVE SALTE ELLER ESTERE DERAF, HERUNDER SUGAMMADEXNATRIUM
1259550 2008C/047 Belgium See Plans and Pricing PRODUCT NAME: SUGAMMADEX SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/08/466001 20080729
1259550 08C0052 France See Plans and Pricing PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550 340 Finland See Plans and Pricing
1259550 122008000068 Germany See Plans and Pricing PRODUCT NAME: SUGAMMADEX ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
Mallinckrodt
Johnson and Johnson
AstraZeneca
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.