FDA Orange Book · active-ingredient family
Finasteride
Finasteride is approved as 2 brand and 22 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PROPECIA · NDA 020788
2
Brand (NDA)
22
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROPECIARLD | ORGANON | NDA 020788 | AB | Dec 19, 1997 | |
| PROSCARRLD | ORGANON | NDA 020180 | AB | Jun 19, 1992 |
Generic (ANDA) products (22)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FINASTERIDE | ALKEM LABS LTD | ANDA 207750 | AB | Jan 06, 2017 | |
| FINASTERIDE | ALKEM LABS LTD | ANDA 204304 | AB | Jan 05, 2017 | |
| FINASTERIDE | CIPLA | ANDA 077335 | — | Nov 20, 2014 | |
| FINASTERIDE | ACCORD HLTHCARE | ANDA 091643 | AB | Nov 05, 2013 | |
| FINASTERIDE | ACTAVIS TOTOWA | ANDA 078371 | — | Nov 05, 2013 | |
| FINASTERIDE | AUROBINDO PHARMA LTD | ANDA 203687 | AB | Nov 05, 2013 | |
| FINASTERIDE | NATCO PHARMA | ANDA 078161 | — | Nov 05, 2013 | |
| FINASTERIDE | TEVA | ANDA 076905 | — | Nov 05, 2013 | |
| FINASTERIDE | HETERO LABS LTD III | ANDA 090060 | AB | Jul 01, 2013 | |
| FINASTERIDE | SUN PHARM | ANDA 090508 | AB | Jul 01, 2013 | |
| FINASTERIDE | SUN PHARM | ANDA 090507 | AB | Aug 16, 2011 | |
| FINASTERIDE | HETERO LABS LTD III | ANDA 090061 | AB | Jun 07, 2010 | |
| FINASTERIDE | ACCORD HLTHCARE | ANDA 090121 | AB | Feb 23, 2010 | |
| FINASTERIDE | ZYDUS PHARMS USA INC | ANDA 078900 | AB | Dec 28, 2009 | |
| FINASTERIDE | AUROBINDO PHARMA | ANDA 078341 | AB | Oct 30, 2007 | |
| FINASTERIDE | ACTAVIS TOTOWA TEVA | ANDA 077914 | — | Mar 28, 2007 | |
| FINASTERIDE | DR REDDYS LABS LTD | ANDA 076437 | AB | Feb 28, 2007 | |
| FINASTERIDE | GEDEON RICHTER USA | ANDA 077251 | — | Dec 22, 2006 | |
| FINASTERIDE | MYLAN | ANDA 077578 | — | Dec 18, 2006 | |
| FINASTERIDE | TEVA | ANDA 076511 | AB | Dec 15, 2006 | |
| FINASTERIDE | DR REDDYS LABS INC | ANDA 076436 | AB | Jul 28, 2006 | |
| FINASTERIDE | IVAX SUB TEVA PHARMS | ANDA 076340 | — | Jun 19, 2006 |
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.
Finasteride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
