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Last Updated: March 3, 2021

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BRIDION Drug 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 are three patents protecting this drug.

This drug has fifty-six 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.

US ANDA Litigation and 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 three 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

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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
Temple UniversityPhase 4
Tetsuro SakaiPhase 1
University of California, Los AngelesPhase 4

See all BRIDION clinical trials

Pharmacology for BRIDION
Paragraph IV (Patent) Challenges for BRIDION
Tradename Dosage Ingredient NDA Submissiondate
BRIDION SOLUTION;INTRAVENOUS sugammadex sodium 022225 2019-12-16

US Patents and Regulatory Information for BRIDION

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   Start Trial   Start Trial Y Y   Start Trial
Organon Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Organon Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 RX Yes No   Start Trial   Start Trial   Start 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 BRIDION

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

Supplementary Protection Certificates for BRIDION

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1259550 2008C/047 Belgium   Start Trial PRODUCT NAME: SUGAMMADEX SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/08/466001 20080729
1259550 300356 Netherlands   Start Trial
1259550 91501 Luxembourg   Start Trial 91501, EXPIRES: 20230725
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Johnson and Johnson
Moodys
Merck
Colorcon

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.