FDA Orange Book · active-ingredient family
Halobetasol propionate; tazarotene
Halobetasol propionate; tazarotene is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DUOBRII · NDA 209354
1
Brand (NDA)
1
Generics (ANDA)
10
Listed patents
0
Exclusivity periods
Brand (NDA) products · lotion
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DUOBRIIRLD | BAUSCH | NDA 209354 | AB | Apr 25, 2019 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HALOBETASOL PROPIONATE AND TAZAROTENE | SUN PHARMA CANADA | ANDA 217190 | AB | May 02, 2025 |
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10478502 | Nov 02, 2031 | in 5 yr 5 mo | ProductU-2625 |
| 11839656 | Nov 02, 2031 | in 5 yr 5 mo | U-2625 |
| 11986527 | Nov 02, 2031 | in 5 yr 5 mo | U-2625 |
| 12076403 | Nov 02, 2031 | in 5 yr 5 mo | Product |
| 8809307 | Nov 02, 2031 | in 5 yr 5 mo | Product |
| 11957753 | Nov 02, 2031 | in 5 yr 5 mo | Product |
| 10426787 | Jun 06, 2036 | in 10 yr 1 mo | U-2625 |
| 11648256 | Jun 06, 2036 | in 10 yr 1 mo | ProductU-2625 |
| 11679115 | Jun 06, 2036 | in 10 yr 1 mo | ProductU-2625 |
| 10251895 | Jun 06, 2036 | in 10 yr 1 mo | Product |
Halobetasol propionate; tazarotene — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
