BENICAR Drug Patent Profile

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

Benicar is a drug marketed by Cosette and is included in two NDAs.

The generic ingredient in BENICAR is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.

Summary for BENICAR

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	17
Patent Applications:	4,730
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BENICAR
Drug Sales Revenues:	Drug sales revenues for BENICAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BENICAR
What excipients (inactive ingredients) are in BENICAR?	BENICAR excipients list
DailyMed Link:	BENICAR at DailyMed

See drug prices for BENICAR

See drug sales revenues for BENICAR

Recent Clinical Trials for BENICAR

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

Sponsor	Phase
EMS	Phase 3
Daiichi Sankyo Co., Ltd.	N/A
Chinese PLA General Hospital	Phase 4

See all BENICAR clinical trials

Pharmacology for BENICAR

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for BENICAR

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for BENICAR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BENICAR	Tablets	olmesartan medoxomil	5 mg, 20 mg and 40 mg	021286	1	2006-04-25

US Patents and Regulatory Information for BENICAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-001	Apr 25, 2002	AB	RX	Yes	No
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003	AB	RX	Yes	No
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-003	Apr 25, 2002	AB	RX	Yes	No
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-004	Apr 25, 2002	AB	RX	Yes	Yes
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003	AB	RX	Yes	Yes
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-003	Jun 5, 2003	AB	RX	Yes	No

Expired US Patents for BENICAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-003	Apr 25, 2002
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-001	Apr 25, 2002
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-004	Apr 25, 2002
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-003	Apr 25, 2002
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-001	Apr 25, 2002
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-004	Apr 25, 2002

International Patents for BENICAR

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

Country	Patent Number	Title	Estimated Expiration
Norway	332938
Germany	122005000051
Denmark	0545912
Russian Federation	95101430
Canada	2097444	DERIVES IMIDAZOLE ANTAGONISTES DE L'ANGIOTENSINE II, LEUR PREPARATION ET LEUR USAGE THERAPEUTIQUE (ANGIOTENSIN II ANTAGONIST IMIDAZOLE DERIVATIVES, THEIR PREPARATION AND THEIR THERAPEUTIC USE)
China	1121859
World Intellectual Property Organization (WIPO)	0241890

Supplementary Protection Certificates for BENICAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	C00503785/03	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0503785	C300486	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
0503785	C300375	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
0503785	91056	Luxembourg		91056, EXPIRES: 20170221
0503785	9/2011	Austria		PRODUCT NAME: KOMBINATION AUS OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, AMLODIPIN BESILAT UND HYDROCHLOROTHIAZID; NAT. REGISTRATION NO/DATE: 1-30068 - 1-30072 20110216; FIRST REGISTRATION: DE 79810.00.00 - 79814.00.00, UND 79815.00.00 - 79819.00.00 20101216
0503785	91847	Luxembourg		91847, EXPIRES: 20170221
0503785	C00503785/02	Switzerland		FORMER OWNER: SANKYO COMPANY LIMITED, JP