Olmesartan medoxomil - Generic Drug Details

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

Olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Cosette, Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma, Chartwell Rx, Glenmark Pharms Ltd, Inventia, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, MSN, Prinston Inc, Qilu, Rising, Sandoz, Sciegen Pharms Inc, Sunshine, Teva Pharms Usa, Torrent, Umedica, and Zydus Pharms, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-six drug master file entries for olmesartan medoxomil. Twenty-nine suppliers are listed for this compound.

Summary for olmesartan medoxomil

US Patents:	0
Tradenames:	2
Applicants:	24
NDAs:	24
Drug Master File Entries:	36
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	80
Patent Applications:	5,685
Drug Prices:	Drug price trends for olmesartan medoxomil
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for olmesartan medoxomil
What excipients (inactive ingredients) are in olmesartan medoxomil?	olmesartan medoxomil excipients list
DailyMed Link:	olmesartan medoxomil at DailyMed

See drug prices for olmesartan medoxomil

Recent Clinical Trials for olmesartan medoxomil

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

Sponsor	Phase
EMS	Phase 3
Seoul National University Bundang Hospital	Phase 4
Shenzhen People's Hospital	Phase 2

See all olmesartan medoxomil clinical trials

Pharmacology for olmesartan medoxomil

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for olmesartan medoxomil

Angiotensin II Type 1 Receptor Blockers
Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for olmesartan medoxomil

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 OLMESARTAN MEDOXOMIL

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 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	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	TABLET;ORAL	206763-001	Apr 24, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	TABLET;ORAL	206720-001	Dec 2, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Msn	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	TABLET;ORAL	217399-003	Jan 18, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	TABLET;ORAL	090237-003	Apr 13, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	TABLET;ORAL	203012-003	Apr 24, 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 olmesartan medoxomil

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-001	Apr 25, 2002	⤷ Sign Up	⤷ Sign Up
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-003	Apr 25, 2002	⤷ Sign Up	⤷ Sign Up
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-004	Apr 25, 2002	⤷ Sign Up	⤷ Sign Up
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-004	Apr 25, 2002	⤷ Sign Up	⤷ Sign Up
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-003	Apr 25, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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