FDA Orange Book · active-ingredient family
Losartan potassium
Losartan potassium: 2 brands, 25 generics; first approved Apr 14, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 25 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
25
Listed patents
3
Next patent expiry
Oct 07, 2041
in 15 yr 2 mo
Brand (NDA) products
Originator applications
- SCIENTURENDA 2187722025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SUSPENSION ORAL Rx — - COZAARRLDORGANONNDA 02038619953 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB
Generic (ANDA) products (25)
Abbreviated applications
- LOSARTAN POTASSIUMGRAVITI PHARMSANDA 21985920253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LOSARTAN POTASSIUMAPOTEXANDA 21855120243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - LOSARTAN POTASSIUMMSNANDA 21739620233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LOSARTAN POTASSIUMGRANULESANDA 21595920233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LOSARTAN POTASSIUMHISUN PHARM HANGZHOUANDA 20479520193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - LOSARTAN POTASSIUMUNICHEMANDA 20303020153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LOSARTAN POTASSIUMHETERO LABS LTD VANDA 20383520153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LOSARTAN POTASSIUMIPCA LABS LTDANDA 20029020133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - LOSARTAN POTASSIUMMICRO LABSANDA 09154120123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - LOSARTAN POTASSIUMJUBILANT CADISTAANDA 20117020123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LOSARTAN POTASSIUMMACLEODS PHARMS LTDANDA 20223020123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LOSARTAN POTASSIUMPRINSTON INCANDA 09149720113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LOSARTAN POTASSIUMAIPING PHARM INCANDA 09054420103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LOSARTAN POTASSIUMALEMBIC PHARMS LTDANDA 09042820103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LOSARTAN POTASSIUMAPOTEX CORPANDA 09079020103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - LOSARTAN POTASSIUMAUROBINDO PHARMAANDA 09008320103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LOSARTAN POTASSIUMCHARTWELL RXANDA 07742420103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LOSARTAN POTASSIUMHIKMAANDA 07745920103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - LOSARTAN POTASSIUMLUPIN LTDANDA 07823220103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LOSARTAN POTASSIUMMYLANANDA 09159020103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - LOSARTAN POTASSIUMSTRIDES PHARMAANDA 09038220103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LOSARTAN POTASSIUMTORRENT PHARMSANDA 09046720103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - LOSARTAN POTASSIUMWATSON LABSANDA 09112920103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LOSARTAN POTASSIUMZYDUS PHARMS USA INCANDA 07824320103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LOSARTAN POTASSIUMTEVAANDA 07695820103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12156869 | in 15 yr 2 mo | ProductU-4158 | |
| 12605365 | in 15 yr 2 mo | ProductU-4159 | |
| 11890273 | in 15 yr 2 mo | Product |
Approval history
FDA approval span
First approval
31 yr 11 mo ago
Most recent approval
1 yr 1 mo ago
Approvals span 1995–2025 across 27 FDA applications.
Brand (NDA) 27%
Generic (ANDA) 2593%
Losartan potassium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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