FDA Orange Book · active-ingredient family
Betamethasone dipropionate
Betamethasone dipropionate is approved as 15 brand and 45 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SERNIVO · NDA 208079
15
Brand (NDA)
45
Generics (ANDA)
7
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, cream, augmented, disc, gel, augmented, lotion, lotion, augmented, ointment, ointment, augmented, spray
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SERNIVORLD | PRIMUS PHARMS | NDA 208079 | — | Feb 05, 2016 | |
| DIPROLENERLD | ORGANON | NDA 019716 | — | Aug 01, 1988 | |
| DIPROLENE AFRLD | ORGANON | NDA 019555 | — | Apr 27, 1987 | |
| BETAMETHASONE DIPROPIONATERLD | FOUGERA PHARMS INC | NDA 019141 | AB | Sep 04, 1984 | |
| BETAMETHASONE DIPROPIONATERLD | FOUGERA PHARMS | NDA 019137 | AB | Jun 26, 1984 | |
| DIPROLENERLD | ORGANON | NDA 018741 | AB | Jul 27, 1983 | |
| DIPROSONERLD | SCHERING | NDA 017781 | — | Approved Prior to Jan 1, 1982 | |
| DIPROLENE×2 | SCHERING | NDA 019408 | — | Jan 31, 1986 | |
| ALPHATREX | SAVAGE LABS | NDA 019143 | — | Sep 04, 1984 | |
| BETAMETHASONE DIPROPIONATE | PHARMADERM | NDA 019140 | — | Sep 04, 1984 | |
| ALPHATREX | SAVAGE LABS | NDA 019138 | — | Jun 26, 1984 | |
| BETAMETHASONE DIPROPIONATE | PHARMADERM | NDA 019136 | — | Jun 26, 1984 | |
| DIPROSONE | SCHERING | NDA 017536 | — | Approved Prior to Jan 1, 1982 | |
| DIPROSONE | SCHERING | NDA 017829 | — | Approved Prior to Jan 1, 1982 | |
| DIPROSONE | SCHERING | NDA 017691 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (45)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BETAMETHASONE DIPROPIONATE | AUROBINDO PHARMA LTD | ANDA 219348 | AB | Jan 26, 2026 | |
| BETAMETHASONE DIPROPIONATE | AUROBINDO PHARMA LTD | ANDA 218289 | AB | Apr 10, 2024 | |
| BETAMETHASONE DIPROPIONATE | PADAGIS ISRAEL | ANDA 215847 | AB | Apr 12, 2022 | |
| BETAMETHASONE DIPROPIONATE | TP ANDA HOLDINGS | ANDA 215186 | AB | Feb 18, 2022 | |
| BETAMETHASONE DIPROPIONATE | ZYDUS LIFESCIENCES | ANDA 214048 | AB | Jul 14, 2020 | |
| BETAMETHASONE DIPROPIONATE | SUN PHARMA CANADA | ANDA 211722 | — | Jun 17, 2020 | |
| BETAMETHASONE DIPROPIONATE | LUPIN | ANDA 209106 | AB | Dec 18, 2019 | |
| BETAMETHASONE DIPROPIONATE | HIKMA | ANDA 208849 | — | Oct 11, 2019 | |
| BETAMETHASONE DIPROPIONATE | ZYDUS PHARMS | ANDA 208885 | AB | Jan 11, 2019 | |
| BETAMETHASONE DIPROPIONATE | COSETTE PHARMS NC | ANDA 210217 | AB | Oct 12, 2018 | |
| BETAMETHASONE DIPROPIONATE | ENCUBE | ANDA 206389 | AB | Feb 13, 2018 | |
| BETAMETHASONE DIPROPIONATE | HIKMA | ANDA 209896 | — | Feb 06, 2018 | |
| BETAMETHASONE DIPROPIONATE | PADAGIS US | ANDA 206118 | — | Nov 09, 2017 | |
| BETAMETHASONE DIPROPIONATE | GLENMARK PHARMS | ANDA 078930 | — | Sep 23, 2008 | |
| BETAMETHASONE DIPROPIONATE | FOUGERA PHARMS | ANDA 077111 | AB | May 21, 2007 | |
| BETAMETHASONE DIPROPIONATE | SUN PHARMA CANADA | ANDA 077477 | AB | May 21, 2007 | |
| BETAMETHASONE DIPROPIONATE | SUN PHARMA CANADA | ANDA 076753 | — | Oct 12, 2004 | |
| BETAMETHASONE DIPROPIONATE | CHARTWELL MOLECULAR | ANDA 076603 | — | Jan 23, 2004 | |
| BETAMETHASONE DIPROPIONATE | FOUGERA PHARMS | ANDA 076215 | AB | Dec 09, 2003 | |
| BETAMETHASONE DIPROPIONATE | PADAGIS ISRAEL | ANDA 076592 | AB | Dec 09, 2003 | |
| BETAMETHASONE DIPROPIONATE | SUN PHARMA CANADA | ANDA 076543 | AB | Dec 09, 2003 | |
| BETAMETHASONE DIPROPIONATE | SUN PHARMA CANADA | ANDA 076508 | AB | Dec 02, 2003 | |
| BETAMETHASONE DIPROPIONATE | FOUGERA PHARMS | ANDA 075276 | AB | May 13, 2003 | |
| BETAMETHASONE DIPROPIONATE | FOUGERA PHARMS | ANDA 075373 | AB | Jun 22, 1999 | |
| BETAMETHASONE DIPROPIONATE | PERRIGO NEW YORK | ANDA 074579 | — | Nov 26, 1997 | |
| BETAMETHASONE DIPROPIONATE | ACTAVIS MID ATLANTIC | ANDA 074304 | AB | Aug 31, 1995 | |
| BETAMETHASONE DIPROPIONATE | SUN PHARMA CANADA | ANDA 074272 | — | Sep 30, 1994 | |
| BETAMETHASONE DIPROPIONATE | SUN PHARMA CANADA | ANDA 074271 | — | Sep 15, 1994 | |
| BETAMETHASONE DIPROPIONATE | SUN PHARMA CANADA | ANDA 073552 | AB | Apr 30, 1992 | |
| BETAMETHASONE DIPROPIONATE | PERRIGO NEW YORK | ANDA 072536 | — | Jan 31, 1990 | |
| BETAMETHASONE DIPROPIONATE | PADAGIS US | ANDA 072538 | AB | Jan 31, 1990 | |
| BETAMETHASONE DIPROPIONATE | PERRIGO NEW YORK | ANDA 072526 | — | Jan 31, 1990 | |
| BETAMETHASONE DIPROPIONATE | SUN PHARMA CANADA | ANDA 072276 | — | Aug 24, 1988 | |
| BETAMETHASONE DIPROPIONATE | COSETTE PHARMS NC | ANDA 071882 | — | Jun 06, 1988 | |
| BETAMETHASONE DIPROPIONATE | TEVA | ANDA 071476 | — | Aug 10, 1987 | |
| BETAMETHASONE DIPROPIONATE | COSETTE PHARMS NC | ANDA 071467 | AB | Aug 10, 1987 | |
| BETAMETHASONE DIPROPIONATE | TEVA | ANDA 071477 | — | Aug 10, 1987 | |
| BETAMETHASONE DIPROPIONATE | SUN PHARMA CANADA | ANDA 071143 | — | Jun 17, 1987 | |
| BETAMETHASONE DIPROPIONATE | ACTAVIS MID ATLANTIC | ANDA 070885 | AB | Feb 03, 1987 | |
| BETAMETHASONE DIPROPIONATE | ALPHARMA US PHARMS | ANDA 071085 | — | Feb 03, 1987 | |
| BETAMETHASONE DIPROPIONATE | ACTAVIS MID ATLANTIC | ANDA 071012 | AB | Feb 03, 1987 | |
| ALPHATREX | SAVAGE LABS | ANDA 070273 | — | Aug 12, 1985 | |
| BETAMETHASONE DIPROPIONATE | FOUGERA PHARMS INC | ANDA 070275 | AB | Aug 12, 1985 | |
| BETAMETHASONE DIPROPIONATE | SHREE HARI INTL | ANDA 070274 | — | Aug 12, 1985 | |
| BETAMETHASONE DIPROPIONATE | ACTAVIS MID ATLANTIC | ANDA 070281 | — | Jul 31, 1985 |
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9775851 | Aug 31, 2030 | in 4 yr 3 mo | ProductU-1858 |
| 9364485 | Aug 31, 2030 | in 4 yr 3 mo | ProductU-1858 |
| 9655907 | Aug 31, 2030 | in 4 yr 3 mo | ProductU-1858 |
| 10179137 | Aug 31, 2030 | in 4 yr 3 mo | ProductU-1858 |
| 9433630 | Aug 31, 2030 | in 4 yr 3 mo | ProductU-1858 |
| 9877974 | Aug 31, 2030 | in 4 yr 3 mo | ProductU-1858 |
| 9439911 | Aug 31, 2030 | in 4 yr 3 mo | ProductU-1858 |
Betamethasone dipropionate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
