FDA Orange Book · active-ingredient family
Betamethasone valerate
Betamethasone valerate is approved as 15 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LUXIQ · NDA 020934
15
Brand (NDA)
18
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · aerosol, foam, cream, lotion, ointment
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LUXIQRLD | PHARMOBEDIENT | NDA 020934 | — | Feb 28, 1999 | |
| BETAMETHASONE VALERATERLD | FOUGERA PHARMS INC | NDA 018861 | AB | Aug 31, 1983 | |
| BETAMETHASONE VALERATERLD | FOUGERA PHARMS INC | NDA 018866 | AB | Aug 31, 1983 | |
| BETAMETHASONE VALERATERLD | FOUGERA PHARMS INC | NDA 018865 | AB | Aug 31, 1983 | |
| BETAMETHASONE VALERATE | PHARMADERM | NDA 018860 | — | Aug 31, 1983 | |
| BETATREX | SAVAGE LABS | NDA 018862 | — | Aug 31, 1983 | |
| BETAMETHASONE VALERATE | PHARMADERM | NDA 018870 | — | Aug 31, 1983 | |
| BETATREX | SAVAGE LABS | NDA 018867 | — | Aug 31, 1983 | |
| BETAMETHASONE VALERATE | PHARMADERM | NDA 018864 | — | Aug 31, 1983 | |
| BETATREX | SAVAGE LABS | NDA 018863 | — | Aug 31, 1983 | |
| BETADERM | ROACO | NDA 018839 | — | Jun 30, 1983 | |
| BETA-VAL | COSETTE PHARMS NC | NDA 018642 | AB | Mar 24, 1983 | |
| VALISONE×2 | SCHERING | NDA 016322 | — | Approved Prior to Jan 1, 1982 | |
| VALISONE | SCHERING | NDA 016932 | — | Approved Prior to Jan 1, 1982 | |
| VALISONE | SCHERING | NDA 016740 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BETAMETHASONE VALERATE | ALEMBIC | ANDA 215832 | AB | Aug 22, 2024 | |
| BETAMETHASONE VALERATE | XIROMED | ANDA 210639 | AB | Apr 18, 2023 | |
| BETAMETHASONE VALERATE | INGENUS PHARMS LLC | ANDA 207144 | — | May 24, 2017 | |
| BETAMETHASONE VALERATE | TARO | ANDA 208204 | AB | May 24, 2017 | |
| BETAMETHASONE VALERATE | PADAGIS ISRAEL | ANDA 078337 | AB | Nov 26, 2012 | |
| BETAMETHASONE VALERATE | TEVA PHARMS | ANDA 071883 | — | Apr 22, 1988 | |
| DERMABET | SUN PHARMA CANADA | ANDA 072041 | AB | Jan 06, 1988 | |
| BETAMETHASONE VALERATE | PERRIGO NEW YORK | ANDA 071478 | — | Dec 23, 1987 | |
| BETAMETHASONE VALERATE | PHARMAFAIR | ANDA 070485 | — | May 29, 1987 | |
| BETAMETHASONE VALERATE | PHARMAFAIR | ANDA 070484 | — | May 29, 1987 | |
| BETAMETHASONE VALERATE | PHARMAFAIR | ANDA 070486 | — | May 29, 1987 | |
| BETAMETHASONE VALERATE | PERRIGO NEW YORK | ANDA 070053 | — | Jun 10, 1986 | |
| BETA-VAL | COSETTE PHARMS NC | ANDA 070069 | AB | Dec 19, 1985 | |
| BETAMETHASONE VALERATE | SENORES PHARMS | ANDA 070052 | AB | Jul 31, 1985 | |
| BETA-VAL | COSETTE PHARMS NC | ANDA 070072 | — | Jun 27, 1985 | |
| BETAMETHASONE VALERATE | SUN PHARMA CANADA | ANDA 070062 | — | May 14, 1985 | |
| VALNAC | ACTAVIS MID ATLANTIC | ANDA 070050 | AB | Oct 10, 1984 | |
| BETAMETHASONE VALERATE | ACTAVIS MID ATLANTIC | ANDA 070051 | AB | Oct 10, 1984 |
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.
Betamethasone valerate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
