AZOR Drug Patent Profile

Which patents cover Azor, and when can generic versions of Azor launch?

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

The generic ingredient in AZOR is amlodipine besylate; olmesartan medoxomil. There are fifty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; olmesartan medoxomil profile page.

Summary for AZOR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	42
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AZOR
What excipients (inactive ingredients) are in AZOR?	AZOR excipients list
DailyMed Link:	AZOR at DailyMed

See drug prices for AZOR

See drug sales revenues for AZOR

Pharmacology for AZOR

Drug Class	Angiotensin 2 Receptor Blocker Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AZOR

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
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 AZOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AZOR	Tablets	amlodipine besylate; olmesartan medoxomil	10 mg/20 mg and 5 mg/40 mg	022100	1	2008-03-31
AZOR	Tablets	amlodipine besylate; olmesartan medoxomil	5 mg/20 mg and 10 mg/40 mg	022100	1	2008-02-11

US Patents and Regulatory Information for AZOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-001	Sep 26, 2007	AB	RX	Yes	No
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-004	Sep 26, 2007	AB	RX	Yes	Yes
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-002	Sep 26, 2007	AB	RX	Yes	No
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-003	Sep 26, 2007	AB	RX	Yes	No

Expired US Patents for AZOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-003	Sep 26, 2007
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-004	Sep 26, 2007
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-001	Sep 26, 2007
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-002	Sep 26, 2007

International Patents for AZOR

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

Country	Patent Number	Title	Estimated Expiration
China	1189490
China	1085896
Japan	H0649036	IMIDAZOLE DERIVATIVE
Canada	2229000	DERIVES DE 1-BIPHENYLIMIDAZOLE, LEUR PREPARATION ET LEUR UTILISATION THERAPEUTIQUE (1-BIPHENYLIMIDAZOLE DERIVATIVES, THEIR PREPARATION AND THEIRTHERAPEUTIC USE)
Portugal	545912

Supplementary Protection Certificates for AZOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	91847	Luxembourg		91847, EXPIRES: 20170221
0503785	C00503785/02	Switzerland		FORMER OWNER: SANKYO COMPANY LIMITED, JP
0502314	SPC/GB11/010	United Kingdom		PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
1915993	300625	Netherlands		PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414