BRIDION Drug Patent Profile

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

Summary for BRIDION

International Patents:	42
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	35
Clinical Trials:	58
Patent Applications:	220
Formulation / Manufacturing:	see details
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

See drug prices for BRIDION

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for BRIDION

NDA:

022225

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

Sponsor	Phase
Guangdong Provincial Hospital of Traditional Chinese Medicine	Phase 4
Tetsuro Sakai	Phase 1
Temple University	Phase 4

See all BRIDION clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BRIDION

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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.

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

FDA Regulatory Exclusivity protecting 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			Y	Y
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015		RX	Yes	Yes			Y	Y
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015		RX	Yes	No
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015		RX	Yes	No
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015		RX	Yes	Yes
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015		RX	Yes	Yes

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
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015

International Patents for BRIDION

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

Country	Patent Number	Title	Estimated Expiration
Japan	2003515623
Denmark	1259550
Israel	149423
Australia	776536
Spain	2237496
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.)
World Intellectual Property Organization (WIPO)	0140316

Supplementary Protection Certificates for BRIDION

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1259550	SPC031/2008	Ireland		SPC031/2008: 20090428, EXPIRES: 20230724
1259550	122008000068	Germany		PRODUCT NAME: SUGAMMADEX ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550	08C0052	France		PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550	2008C/047	Belgium		PRODUCT NAME: SUGAMMADEX SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/08/466001 20080729
1259550	SZ 47/2008	Austria		PRODUCT NAME: SUGAMMADEX; 6-PER-DEOXY-6-PER-(2-CARBOXYETHYL) THIO-Y-CYCLODEXTRIN UND PHARMAZEUTISCH VERTRÄGLICHES SALZ HIERVON
1259550	91501	Luxembourg		91501, EXPIRES: 20230725
1259550	C01259550/01	Switzerland		FUSION; FORMER OWNER: ORGANON BIO SCIENCES NEDERLAND B.V., NL