Hydrochlorothiazide; olmesartan medoxomil - Generic Drug Details
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What are the generic drug 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 |
|---|---|
| Pharmtechnology LLC | Phase 1 |
| Altasciences Company, Inc. | Phase 1 |
| Altasciences Company Inc. | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 204233-001 | Apr 24, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Accord Hlthcare | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 209281-003 | Feb 7, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alkem Labs Ltd | HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 207037-003 | Jul 11, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Accord Hlthcare | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 209281-002 | Feb 7, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-003 | Jun 5, 2003 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Natco Pharma Usa | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 078827-001 | Oct 26, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Prinston Inc | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 207804-001 | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 | 021532-003 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-005 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-005 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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