FDA Orange Book · active-ingredient family
Ulipristal acetate
Ulipristal acetate 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:ELLA · NDA 022474
1
Brand (NDA)
1
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ELLARLD | LAB HRA PHARMA | NDA 022474 | AB | Aug 13, 2010 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOGILIA | TEVA PHARMS USA | ANDA 207952 | AB | Feb 13, 2017 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9844510 | Dec 08, 2028 | in 2 yr 6 mo | Product |
| 8735380 | Feb 20, 2029 | in 2 yr 9 mo | Product |
| 9283233 | Apr 13, 2030 | in 3 yr 10 mo | U-1821 |
| 10159681 | Apr 13, 2030 | in 3 yr 10 mo | U-2510 |
| 10772897 | Apr 13, 2030 | in 3 yr 10 mo | U-2958 |
| 8512745 | Jun 02, 2030 | in 4 yr | Product |
| 8426392 | Jun 12, 2030 | in 4 yr | U-1389 |
| 8962603 | Jun 12, 2030 | in 4 yr | U-1657 |
Ulipristal acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
