FDA Orange Book · active-ingredient family
Lovastatin
Lovastatin is approved as 2 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ALTOPREV · NDA 021316
2
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALTOPREVRLD×4 | AZURITY | NDA 021316 | — | Jun 26, 2002 | |
| MEVACORRLD×3 | MERCK | NDA 019643 | — | Mar 28, 1991 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOVASTATIN×3 | LUPIN | ANDA 078296 | AB | Mar 14, 2008 | |
| LOVASTATIN×3 | COREPHARMA | ANDA 077748 | AB | Feb 28, 2007 | |
| LOVASTATIN×3 | SUN PHARM INDUSTRIES | ANDA 077520 | — | Apr 14, 2006 | |
| LOVASTATIN×3 | CARLSBAD | ANDA 075991 | AB | Jun 05, 2002 | |
| LOVASTATIN×3 | ACTAVIS ELIZABETH | ANDA 075828 | AB | Dec 17, 2001 | |
| LOVASTATIN×3 | AUROBINDO PHARMA USA | ANDA 075451 | — | Dec 17, 2001 | |
| LOVASTATIN×3 | AUROBINDO PHARMA USA | ANDA 075935 | — | Dec 17, 2001 | |
| LOVASTATIN×3 | CHARTWELL RX | ANDA 075300 | AB | Dec 17, 2001 | |
| LOVASTATIN×3 | EPIC PHARMA LLC | ANDA 075636 | AB | Dec 17, 2001 | |
| LOVASTATIN×3 | TEVA | ANDA 075551 | AB | Dec 17, 2001 |
Listed patents
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.
Lovastatin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
