FDA Orange Book · active-ingredient family
Darifenacin hydrobromide
Darifenacin hydrobromide is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ENABLEX · NDA 021513
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ENABLEXRLD×2 | ABBVIE | NDA 021513 | — | Dec 22, 2004 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DARIFENACIN HYDROBROMIDE×2 | PURACAP LABS BLU | ANDA 211045 | AB | Jan 06, 2020 | |
| DARIFENACIN HYDROBROMIDE×2 | XIROMED | ANDA 209571 | — | Oct 22, 2019 | |
| DARIFENACIN HYDROBROMIDE×2 | ALEMBIC | ANDA 207681 | AB | Dec 08, 2017 | |
| DARIFENACIN×2 | MACLEODS PHARMS LTD | ANDA 207302 | AB | Jul 28, 2017 | |
| DARIFENACIN HYDROBROMIDE×2 | TORRENT | ANDA 205209 | AB | Nov 17, 2016 | |
| DARIFENACIN HYDROBROMIDE×2 | JUBILANT GENERICS | ANDA 205550 | — | Oct 12, 2016 | |
| DARIFENACIN HYDROBROMIDE×2 | AUROBINDO PHARMA | ANDA 206743 | AB | Sep 19, 2016 | |
| DARIFENACIN HYDROBROMIDE×2 | CIPLA | ANDA 207664 | AB | Sep 01, 2016 | |
| DARIFENACIN HYDROBROMIDE×2 | PH HEALTH | ANDA 091190 | — | Mar 13, 2015 |
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.
Darifenacin hydrobromide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
