AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - Generic Drug Details

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What are the generic sources for amlodipine besylate; olmesartan medoxomil and what is the scope of freedom to operate?

Amlodipine besylate; olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Accord Hlthcare Inc, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Micro Labs, Sciegen Pharms Inc, Teva Pharms Usa, Torrent, Zydus Pharms, and Cosette, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	18
Clinical Trials:	4
DailyMed Link:	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL at DailyMed

Recent Clinical Trials for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

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

Sponsor	Phase
Daiichi Sankyo, Inc.	Phase 3
Daiichi Sankyo Inc.	Phase 3
Daiichi Sankyo, Inc.	Phase 4

See all AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL clinical trials

Generic filers with tentative approvals for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	10MG/40MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	10MG/20MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	5MG/40MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

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 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

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 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

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 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	209042-002	Aug 14, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	209042-004	Aug 14, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Micro Labs	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	207435-001	Nov 2, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sciegen Pharms Inc	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	209010-001	Dec 3, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	207807-003	Jul 5, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

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

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