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 Msd 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. Two suppliers are listed for this compound. Additional details are available on the sugammadex sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bridion

A generic version of BRIDION was approved as sugammadex sodium by ASPIRO on June 9^th, 2023.

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Summary for BRIDION

International Patents:	42
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	65
Patent Applications:	130
Drug Prices:	Drug price information for BRIDION
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRIDION
What excipients (inactive ingredients) are in BRIDION?	BRIDION excipients list
DailyMed Link:	BRIDION at DailyMed

Drug patent expirations by year for BRIDION

Recent Clinical Trials for BRIDION

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

Sponsor	Phase
Korea University Ansan Hospital	Phase 4
Seoul National University Hospital	N/A
Radboud University Medical Center	Phase 2

See all BRIDION clinical trials

Pharmacology 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.

Patents protecting BRIDION

6-mercapto-cyclodextrin derivatives:reversal agents for drug-induced neuromuscular block
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REVERSAL OF DRUG-INDUCED NEUROMUSCULAR BLOCK

FDA Regulatory Exclusivity protecting BRIDION

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up

REVISIONS TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE PACKAGE INSERT TO INCLUDE THE RESULT OF STUDY P145
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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	022225-002	Dec 15, 2015	AP	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	AP	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	AP	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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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	⤷ Sign Up	⤷ Sign Up
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	⤷ Sign Up	⤷ Sign Up
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	⤷ Sign Up	⤷ Sign Up
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	⤷ Sign Up	⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
Colombia	5251450	DERIVADOS DE 6-MERCAPTO-CICLODEXTRINA	⤷ Sign Up
Portugal	1259550		⤷ Sign Up
Japan	2003507335		⤷ Sign Up
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)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BRIDION

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1259550	122008000068	Germany	⤷ Sign Up	PRODUCT NAME: SUGAMMADEX ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550	SPC031/2008	Ireland	⤷ Sign Up	SPC031/2008: 20090428, EXPIRES: 20230724
1259550	47/2008	Austria	⤷ Sign Up	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	C01259550/01	Switzerland	⤷ Sign Up	FUSION; FORMER OWNER: ORGANON BIO SCIENCES NEDERLAND B.V., NL
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description