Azor Drug Patent Profile

Which patents cover Azor, and what generic alternatives are available?

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. Sixteen 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	022100-001	Sep 26, 2007
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-004	Sep 26, 2007
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-002	Sep 26, 2007

International Patents for Azor

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

Country	Patent Number	Title	Estimated Expiration
Germany	122011000011
Israel	101034	1-Biphenylimidazole derivatives processes for the preparation thereof and pharmaceutical compositions containing the same
Czech Republic	289244	1-Bifenylmethylimidazolové deriváty, způsob výroby a farmaceutické prostředky s jejich obsahem (1-Biphenylmethylimidazole derivatives, process of their preparation and pharmaceutical preparations in which they are comprised)
Japan	H0649036	IMIDAZOLE DERIVATIVE
Canada	2229000	DERIVES DE 1-BIPHENYLIMIDAZOLE, LEUR PREPARATION ET LEUR UTILISATION THERAPEUTIQUE (1-BIPHENYLIMIDAZOLE DERIVATIVES, THEIR PREPARATION AND THEIRTHERAPEUTIC USE)
Austria	200778
Germany	10299043

Supplementary Protection Certificates for Azor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1003503	05C0048	France		PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
0503785	C00503785/02	Switzerland		FORMER OWNER: SANKYO COMPANY LIMITED, JP
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
1915993	92315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
1507558	C300528	Netherlands		PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705