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, Chartwell Rx, Granules, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Jubilant Cadista, Lupin Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, Teva Pharms, Torrent Pharms, Unichem, Watson Labs, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.Thirty suppliers are listed for this compound.
Summary for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 19 |
| NDAs: | 19 |
| Finished Product Suppliers / Packagers: | 30 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Macleods Pharms Ltd | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 202289-003 | Aug 9, 2012 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Aurobindo Pharma | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 091629-001 | Oct 6, 2010 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Watson Labs | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 200180-003 | Jan 12, 2011 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Lupin Ltd | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 078245-001 | Oct 6, 2010 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Teva Pharms | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 077157-001 | Apr 6, 2010 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Lupin Ltd | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 078245-003 | Oct 6, 2010 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Macleods Pharms Ltd | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 202289-001 | Aug 9, 2012 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >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 | 020387-001 | Apr 28, 1995 | 5,608,075 | ⤷ Start Trial |
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-002 | Nov 10, 1998 | 5,608,075 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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ISSN: 2162-2639
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