BRIDION Drug Patent Profile

When do Bridion patents expire, and what generic alternatives are available?

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.

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:	43
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

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

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.

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

Expired US Patents for BRIDION

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015
Msd 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
World Intellectual Property Organization (WIPO)	0140316
South Korea	100716524
Israel	149423
Czech Republic	298206	Deriváty 6-merkaptocyklodextrinu a farmaceutický prostredek (6-Mercaptocyclodextrin derivatives and pharmaceutical composition)
Canada	2390463	DERIVES DE 6-MERCAPTO-CYCLODEXTRINE: AGENTS D'INVERSION DU BLOCAGE NEUROMUSCULAIRE PROVOQUE PAR DES SUBSTANCES MEDICAMENTEUSES (6-MERCAPTO-CYCLODEXTRIN DERIVATIVES: REVERSAL AGENTS FOR DRUG-INDUCED NEUROMUSCULAR BLOCK)
New Zealand	518752	6-mercapto-cyclodextrin derivatives that are useful as reversal agents for drug-induced neuromuscular block
Australia	780416

Supplementary Protection Certificates for BRIDION

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1259550	SPC/GB08/057	United Kingdom		PRODUCT NAME: SUGAMMADEX; REGISTERED: UK EU/1/08/466/001 20080725; UK EU/1/08/466/002 20080725
1259550	CA 2009 00002	Denmark		PRODUCT NAME: SUGAMMADEX ELLER FARMACEUTISK AKTIVE SALTE ELLER ESTERE DERAF, HERUNDER SUGAMMADEXNATRIUM
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	2008C/047	Belgium		PRODUCT NAME: SUGAMMADEX SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/08/466001 20080729
1259550	47/2008	Austria		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	SZ 47/2008	Austria		PRODUCT NAME: SUGAMMADEX; 6-PER-DEOXY-6-PER-(2-CARBOXYETHYL) THIO-Y-CYCLODEXTRIN UND PHARMAZEUTISCH VERTRÄGLICHES SALZ HIERVON