HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - Generic Drug Details

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

Hydrochlorothiazide; olmesartan medoxomil is the generic ingredient in three branded drugs marketed by Cosette, Alkem Labs Ltd, Accord Hlthcare, Alembic, Aurobindo Pharma, Macleods Pharms Ltd, Natco Pharma Usa, Prinston Inc, Teva Pharms Usa, Torrent, Umedica, and Zydus Pharms, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

Twelve suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

US Patents:	0
Tradenames:	3
Applicants:	12
NDAs:	12
Finished Product Suppliers / Packagers:	12
Clinical Trials:	26
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
DailyMed Link:	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL at DailyMed

Recent Clinical Trials for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

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

Sponsor	Phase
Altasciences Company, Inc.	Phase 1
Altasciences Company Inc.	Phase 1
Pharmtechnology LLC	Phase 1

See all HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

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 HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

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 HYDROCHLOROTHIAZIDE; 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
Prinston Inc	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	207804-003	Apr 24, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	205391-001	Apr 24, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	205391-002	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 HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

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

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