HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM - Generic Drug Details
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What are the generic sources for hydrochlorothiazide; losartan potassium and what is the scope of patent protection?
Hydrochlorothiazide; losartan potassium
is the generic ingredient in two branded drugs marketed by Organon, Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Granules, Hikma, Ipca Labs Ltd, Jubilant Cadista, Lupin Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, Sandoz, Teva Pharms, Torrent Pharms, Unichem, Watson Labs, and Zydus Pharms Usa Inc, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.Thirty-one suppliers are listed for this compound.
Summary for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 18 |
| NDAs: | 18 |
| Finished Product Suppliers / Packagers: | 31 |
| Clinical Trials: | 15 |
| DailyMed Link: | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM at DailyMed |
Recent Clinical Trials for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shanghai Jiao Tong University School of Medicine | Phase 4 |
| Kyushu University | Phase 3 |
| Federico II University | Phase 4 |
See all HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM clinical trials
Pharmacology for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
| 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; LOSARTAN POTASSIUM
Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| HYZAAR | Tablets | hydrochlorothiazide; losartan potassium | 100 mg/12.5 mg | 020387 | 1 | 2006-04-04 |
| HYZAAR | Tablets | hydrochlorothiazide; losartan potassium | 50 mg/12.5 mg and 100 mg/25 mg | 020387 | 1 | 2004-05-24 |
US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 077948-001 | Oct 6, 2010 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Unichem | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 204832-003 | Jul 21, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Jubilant Cadista | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 201845-003 | Sep 18, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 077157-002 | Apr 6, 2010 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Granules | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 218015-001 | Sep 29, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Granules | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 218015-002 | Sep 29, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 090150-001 | Oct 6, 2010 | DISCN | 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; LOSARTAN POTASSIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-002 | Nov 10, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-001 | Apr 28, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-002 | Nov 10, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-001 | Apr 28, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-002 | Nov 10, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-003 | Oct 20, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-002 | Nov 10, 1998 | ⤷ 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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