BENICAR Drug Patent Profile

Which patents cover Benicar, 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. Thirteen 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
Australia	661153
Germany	69231798
Norway	304517
Japan	H0649036	IMIDAZOLE DERIVATIVE
Norway	2009019
Netherlands	300375

Supplementary Protection Certificates for BENICAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	C00503785/01	Switzerland		FORMER OWNER: SANKYO COMPANY LIMITED, JP
0503785	C00503785/04	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0503785	91330	Luxembourg		CERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
0503785	CA 2009 00015	Denmark		PRODUCT NAME: EN KOMBINATION AF OLMESARTANMEDOXOMIL, EVT. I FORM AF ET FARMACEUTISK ACCEPTABELT SALT OG AMLODIPIN-BESILAT; NAT. REG. NO/DATE: MT 42061, 42062, 42063 20081120; FIRST REG. NO/DATE: NL RVG 100984 20080819
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	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216