FDA Orange Book · active-ingredient family
Ursodiol
Ursodiol is approved as 2 brand and 22 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:URSO 250 · NDA 020675
2
Brand (NDA)
22
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| URSO 250RLD×2 | ABBVIE | NDA 020675 | — | Dec 10, 1997 | |
| ACTIGALLRLD×2 | TEVA BRANDED PHARM | NDA 019594 | AB | Dec 31, 1987 |
Generic (ANDA) products (22)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| URSODIOL×2 | STRIDES PHARMA | ANDA 210344 | — | Jan 16, 2026 | |
| URSODIOL×2 | EPIC PHARMA LLC | ANDA 214717 | AB | Aug 14, 2024 | |
| URSODIOL | AUROBINDO PHARMA LTD | ANDA 214849 | AB | Nov 28, 2022 | |
| URSODIOL | RK PHARMA | ANDA 214329 | AB | Jul 28, 2021 | |
| URSODIOL | ZYDUS LIFESCIENCES | ANDA 214295 | AB | Oct 16, 2020 | |
| URSODIOL×2 | STRIDES PHARMA | ANDA 213504 | AB | Aug 20, 2020 | |
| URSODIOL | CHARTWELL RX | ANDA 213555 | AB | Aug 17, 2020 | |
| URSODIOL×2 | LGM PHARMA | ANDA 205789 | — | May 08, 2020 | |
| URSODIOL | RISING | ANDA 213200 | AB | Feb 12, 2020 | |
| URSODIOL | HIBROW HLTHCARE | ANDA 212452 | AB | Oct 30, 2019 | |
| URSODIOL×2 | ZYDUS LIFESCIENCES | ANDA 211145 | AB | Oct 30, 2018 | |
| URSODIOL | AMNEAL PHARMS CO | ANDA 211301 | — | Oct 16, 2018 | |
| URSODIOL | ABHAI LLC | ANDA 210707 | AB | May 17, 2018 | |
| URSODIOL×2 | PH HEALTH | ANDA 202540 | AB | Feb 14, 2013 | |
| URSODIOL×2 | IMPAX LABS INC | ANDA 200826 | — | Dec 23, 2011 | |
| URSODIOL×2 | GLENMARK PHARMS LTD | ANDA 090801 | AB | Jul 12, 2011 | |
| URSODIOL | QUAGEN | ANDA 090530 | — | Feb 17, 2010 | |
| URSODIOL×2 | TEVA PHARMS USA | ANDA 079184 | — | May 13, 2009 | |
| URSODIOL | LANNETT CO INC | ANDA 079082 | AB | Dec 15, 2008 | |
| URSODIOL | IMPAX LABS INC | ANDA 077895 | — | Jul 27, 2006 | |
| URSODIOL | TEVA PHARMS | ANDA 075592 | — | May 25, 2000 | |
| URSODIOL | EPIC PHARMA | ANDA 075517 | AB | Mar 14, 2000 |
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.
Ursodiol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
