FDA Orange Book · active-ingredient family
Lovastatin
Lovastatin: 2 brands, 10 generics; first approved Aug 31, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 10 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
10
Listed patents
0
Presentations
37
Brand (NDA) products
Originator applications
- ALTOPREVRLDAZURITYNDA 02131620024 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Discontinued — 20MG TABLET, EXTENDED RELEASE ORAL Discontinued — 40MG TABLET, EXTENDED RELEASE ORAL Discontinued — 60MG TABLET, EXTENDED RELEASE ORAL Discontinued — - MEVACORRLDMERCKNDA 01964319913 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET ORAL Discontinued — 40MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET ORAL Discontinued —
Generic (ANDA) products (10)
Abbreviated applications
- LOVASTATINLUPINANDA 07829620083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - LOVASTATINCOREPHARMAANDA 07774820073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - LOVASTATINSUN PHARM INDUSTRIESANDA 07752020063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - LOVASTATINCARLSBADANDA 07599120023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - LOVASTATINACTAVIS ELIZABETHANDA 07582820013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - LOVASTATINAUROBINDO PHARMA USAANDA 07545120013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - LOVASTATINAUROBINDO PHARMA USAANDA 07593520013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - LOVASTATINCHARTWELL RXANDA 07530020013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - LOVASTATINEPIC PHARMA LLCANDA 07563620013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - LOVASTATINTEVAANDA 07555120013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
39 yr 8 mo ago
Most recent approval
18 yr 10 mo ago
Approvals span 1987–2008 across 12 FDA applications.
Brand (NDA) 217%
Generic (ANDA) 1083%
Lovastatin: 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.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 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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