BENICAR HCT Drug Patent Profile

When do Benicar Hct patents expire, and when can generic versions of Benicar Hct launch?

Benicar Hct is a drug marketed by Cosette and is included in one NDA.

The generic ingredient in BENICAR HCT 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 HCT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	17
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BENICAR HCT
Drug Sales Revenues:	Drug sales revenues for BENICAR HCT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BENICAR HCT
What excipients (inactive ingredients) are in BENICAR HCT?	BENICAR HCT excipients list
DailyMed Link:	BENICAR HCT at DailyMed

See drug prices for BENICAR HCT

See drug sales revenues for BENICAR HCT

Recent Clinical Trials for BENICAR HCT

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 HCT clinical trials

Pharmacology for BENICAR HCT

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for BENICAR HCT

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

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 HCT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BENICAR HCT	Tablets	hydrochlorothiazide; olmesartan medoxomil	20 mg/12.5 mg	021532	1	2007-05-11
BENICAR HCT	Tablets	hydrochlorothiazide; olmesartan medoxomil	40 mg/12.5 mg and 40 mg/25 mg	021532	1	2007-02-15

US Patents and Regulatory Information for BENICAR HCT

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

Expired US Patents for BENICAR HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-003	Jun 5, 2003
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-003	Jun 5, 2003
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003

International Patents for BENICAR HCT

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

Country	Patent Number	Title	Estimated Expiration
Austria	200778
Australia	3988093
Russian Federation	2128173	DERIVATIVES OF 1-BIPHENYLMETHYLIMIDAZOLE, A METHOD OF THEIR SYNTHESIS AND A PHARMACEUTICAL COMPOSITION FOR TREATMENT AND PROPHYLAXIS OF PATIENTS WITH HYPERTENSION
China	1045770
Luxembourg	91330
Mexico	PA03004463	COMPOSICIONES MEDICAS. (MEDICINAL COMPOSITIONS.)

Supplementary Protection Certificates for BENICAR HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
0503785	03C0037	France		PRODUCT NAME: OLMESARTAN MEDOXOMIL; NAT. REGISTRATION NO/DATE: NL28292 20030806; FIRST REGISTRATION: DE - 50202.00 20020813
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
0454511	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
0503785	20/2009	Austria		PRODUCT NAME: KOMBINATION VON OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, MIT AMLODIPINBESILAT; NAT. REGISTRATION NO/DATE: 1-27894, 1-27895, 1-27896 20081217; FIRST REGISTRATION: NL 100989, 100990, 100991 20080819
0502314	SPC/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419