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Last Updated: May 26, 2022

BRIDION Drug Patent Profile


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When do Bridion patents expire, and when can generic versions of Bridion launch?

Bridion is a drug marketed by Organon Sub Merck and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-two patent family members in thirty countries.

The generic ingredient in BRIDION is sugammadex sodium. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sugammadex sodium profile page.

DrugPatentWatch® Generic Entry Outlook for Bridion

Bridion was eligible for patent challenges on December 15, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 27, 2026. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for BRIDION
Drug Prices for BRIDION

See drug prices for BRIDION

DrugPatentWatch® Estimated Generic Entry Opportunity Date for BRIDION
Generic Entry Date for BRIDION*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BRIDION

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

SponsorPhase
Guangdong Provincial Hospital of Traditional Chinese MedicinePhase 4
Tetsuro SakaiPhase 1
Temple UniversityPhase 4

See all BRIDION clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BRIDION
Paragraph IV (Patent) Challenges for BRIDION
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 BRIDION

BRIDION is protected by one US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BRIDION is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting BRIDION

6-mercapto-cyclodextrin derivatives:reversal agents for drug-induced neuromuscular block
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REVERSAL OF DRUG-INDUCED NEUROMUSCULAR BLOCK

FDA Regulatory Exclusivity protecting BRIDION

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

REVISIONS TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE PACKAGE INSERT TO INCLUDE THE RESULT OF STUDY P146 TO FULFILL THE REQUIREMENTS OF PMR 3003-4
Exclusivity Expiration: 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
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 022225-002 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 022225-001 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 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 BRIDION

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 022225-001 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for BRIDION

See the table below for patents covering BRIDION around the world.

Country Patent Number Title Estimated Expiration
Japan 2003515623 See Plans and Pricing
Denmark 1259550 See Plans and Pricing
Israel 149423 See Plans and Pricing
Australia 776536 See Plans and Pricing
Spain 2237496 See Plans and Pricing
Mexico PA02001545 USO DE QUELADORES QUIMICOS COMO AGENTES DE REVERSION PARA EL BLOQUEO NEUROMUSCULAR INDUCIDO POR FARMACO. (USE OF CHEMICAL CHELATORS AS REVERSAL AGENTS FOR DRUG-INDUCED NEUROMUSCULAR BLOCK.) See Plans and Pricing
World Intellectual Property Organization (WIPO) 0140316 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BRIDION

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1259550 SPC031/2008 Ireland See Plans and Pricing SPC031/2008: 20090428, EXPIRES: 20230724
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
1259550 08C0052 France See Plans and Pricing PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550 2008C/047 Belgium See Plans and Pricing PRODUCT NAME: SUGAMMADEX SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/08/466001 20080729
1259550 SZ 47/2008 Austria See Plans and Pricing PRODUCT NAME: SUGAMMADEX; 6-PER-DEOXY-6-PER-(2-CARBOXYETHYL) THIO-Y-CYCLODEXTRIN UND PHARMAZEUTISCH VERTR√ĄGLICHES SALZ HIERVON
1259550 91501 Luxembourg See Plans and Pricing 91501, EXPIRES: 20230725
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:

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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.