FDA Orange Book · active-ingredient family
Minoxidil
Minoxidil is approved as 4 brand and 33 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MEN'S ROGAINE · NDA 021812
4
Brand (NDA)
33
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · aerosol, foam, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MEN'S ROGAINERLD×2 | KENVUE BRANDS | NDA 021812 | — | Jan 20, 2006 | |
| ROGAINE EXTRA STRENGTH (FOR MEN)RLD | KENVUE BRANDS | NDA 020834 | — | Nov 14, 1997 | |
| ROGAINE (FOR MEN)RLD×2 | KENVUE BRANDS | NDA 019501 | — | Feb 09, 1996 | |
| LONITENRLD×2 | PFIZER | NDA 018154 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (33)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MINOXIDIL EXTRA STRENGTH (FOR MEN) | TARO | ANDA 217998 | — | Jun 30, 2025 | |
| MINOXIDIL (FOR WOMEN) | TARO | ANDA 218175 | — | Nov 26, 2024 | |
| MINOXIDIL (FOR MEN)×2 | AUROBINDO PHARMA | ANDA 218616 | — | Apr 22, 2024 | |
| MINOXIDIL (FOR MEN)×2 | TARO | ANDA 209074 | — | Dec 31, 2018 | |
| MINOXIDIL (FOR MEN)×2 | P AND L | ANDA 208092 | — | Feb 17, 2017 | |
| MINOXIDIL | PERRIGO PHARMA INTL | ANDA 091344 | — | Apr 28, 2011 | |
| THEROXIDIL | PURE SOURCE | ANDA 078176 | — | Nov 09, 2007 | |
| THEROXIDIL | PURE SOURCE | ANDA 076239 | — | Aug 24, 2004 | |
| MINOXIDIL EXTRA STRENGTH (FOR MEN) | AUROBINDO PHARMA LTD | ANDA 075438 | — | Feb 27, 2003 | |
| MINOXIDIL EXTRA STRENGTH (FOR MEN) | PERRIGO NEW YORK | ANDA 075737 | — | Mar 15, 2002 | |
| MINOXIDIL EXTRA STRENGTH (FOR MEN) | APOTEX INC | ANDA 075839 | — | Oct 01, 2001 | |
| MINOXIDIL EXTRA STRENGTH (FOR MEN) | PERRIGO | ANDA 075598 | — | Jun 13, 2001 | |
| MINOXIDIL EXTRA STRENGTH (FOR MEN) | AVACOR PRODS | ANDA 075619 | — | Nov 17, 2000 | |
| MINOXIDIL EXTRA STRENGTH (FOR MEN) | P AND L | ANDA 075518 | — | Nov 17, 2000 | |
| MINOXIDIL (FOR MEN)×2 | L PERRIGO CO | ANDA 075357 | — | Jul 30, 1999 | |
| MINOXIDIL (FOR MEN)×2 | APOTEX INC | ANDA 074924 | — | Apr 29, 1998 | |
| MINOXIDIL (FOR MEN)×2 | AUROBINDO PHARMA LTD | ANDA 074767 | — | Feb 28, 1997 | |
| MINOXIDIL (FOR MEN)×2 | HIKMA | ANDA 074731 | — | Dec 24, 1996 | |
| MINOXIDIL (FOR MEN)×2 | SIGHT PHARMS | ANDA 074743 | — | Oct 18, 1996 | |
| MINOXIDIL (FOR MEN) | COPLEY PHARM | ANDA 074500 | — | May 23, 1996 | |
| MINOXIDIL (FOR MEN) | BAUSCH AND LOMB | ANDA 074643 | — | Apr 09, 1996 | |
| MINOXIDIL (FOR MEN) | P AND L | ANDA 074588 | — | Apr 05, 1996 | |
| MINOXIDIL (FOR MEN) | TEVA | ANDA 074589 | — | Apr 05, 1996 | |
| MINOXIDIL×2 | SUN PHARM INDUSTRIES | ANDA 072709 | AB | Dec 14, 1995 | |
| MINOXIDIL | USL PHARMA | ANDA 071537 | — | Dec 16, 1988 | |
| MINOXIDIL | PH HEALTH | ANDA 071826 | AB | Nov 14, 1988 | |
| MINOXIDIL | PH HEALTH | ANDA 071839 | AB | Nov 14, 1988 | |
| MINODYL | QUANTUM PHARMICS | ANDA 072153 | — | Jul 13, 1988 | |
| MINOXIDIL | ROYCE LABS | ANDA 071799 | — | Nov 10, 1987 | |
| MINOXIDIL | ROYCE LABS | ANDA 071796 | — | Nov 10, 1987 | |
| MINODYL | QUANTUM PHARMICS | ANDA 071534 | — | Mar 19, 1987 | |
| MINOXIDIL | WATSON LABS | ANDA 071344 | AB | Mar 03, 1987 | |
| MINOXIDIL | WATSON LABS | ANDA 071345 | AB | Mar 03, 1987 |
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.
Minoxidil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
