FDA Orange Book · active-ingredient family
Solifenacin succinate
Solifenacin succinate is approved as 2 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VESICARE LS · NDA 209529
2
Brand (NDA)
26
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VESICARE LSRLD | ASTELLAS | NDA 209529 | — | May 26, 2020 | |
| VESICARERLD×2 | ASTELLAS | NDA 021518 | — | Nov 19, 2004 |
Generic (ANDA) products (26)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SOLIFENACIN SUCCINATE×2 | TORRENT | ANDA 209424 | — | Mar 04, 2025 | |
| SOLIFENACIN SUCCINATE×2 | JUBILANT GENERICS | ANDA 205484 | AB | Oct 02, 2024 | |
| SOLIFENACIN SUCCINATE×2 | MACLEODS PHARMS LTD | ANDA 204374 | AB | Feb 20, 2024 | |
| SOLIFENACIN SUCCINATE×2 | LANNETT CO INC | ANDA 211622 | — | Jun 06, 2023 | |
| SOLIFENACIN SUCCINATE×2 | AUROBINDO PHARMA | ANDA 206817 | AB | Dec 27, 2022 | |
| SOLIFENACIN SUCCINATE×2 | ANNORA PHARMA | ANDA 215761 | AB | Jun 15, 2022 | |
| SOLIFENACIN SUCCINATE×2 | ACCORD HLTHCARE | ANDA 207477 | — | Jan 04, 2022 | |
| SOLIFENACIN SUCCINATE×2 | ZYDUS PHARMS | ANDA 207721 | — | Oct 19, 2020 | |
| SOLIFENACIN SUCCINATE×2 | SUNSHINE | ANDA 213346 | AB | Apr 13, 2020 | |
| SOLIFENACIN SUCCINATE×2 | RISING | ANDA 211423 | AB | Dec 11, 2019 | |
| SOLIFENACIN SUCCINATE×2 | NOVITIUM PHARMA | ANDA 212214 | AB | Sep 26, 2019 | |
| SOLIFENACIN SUCCINATE×2 | UNICHEM | ANDA 211701 | AB | Aug 27, 2019 | |
| SOLIFENACIN SUCCINATE×2 | AJANTA PHARMA LTD | ANDA 205483 | — | May 20, 2019 | |
| SOLIFENACIN SUCCINATE×2 | ALEMBIC | ANDA 205575 | AB | May 20, 2019 | |
| SOLIFENACIN SUCCINATE×2 | ALKEM LABS LTD | ANDA 210224 | AB | May 20, 2019 | |
| SOLIFENACIN SUCCINATE×2 | AMNEAL PHARMS CO | ANDA 209719 | — | May 20, 2019 | |
| SOLIFENACIN SUCCINATE×2 | BOSTAL | ANDA 210281 | AB | May 20, 2019 | |
| SOLIFENACIN SUCCINATE×2 | BRECKENRIDGE | ANDA 209818 | — | May 20, 2019 | |
| SOLIFENACIN SUCCINATE×2 | CHARTWELL RX | ANDA 210582 | AB | May 20, 2019 | |
| SOLIFENACIN SUCCINATE×2 | CIPLA | ANDA 209839 | — | May 20, 2019 | |
| SOLIFENACIN SUCCINATE×2 | GLENMARK SPECLT | ANDA 209239 | AB | May 20, 2019 | |
| SOLIFENACIN SUCCINATE×2 | MSN | ANDA 210688 | AB | May 20, 2019 | |
| SOLIFENACIN SUCCINATE×2 | QILU | ANDA 209333 | AB | May 20, 2019 | |
| SOLIFENACIN SUCCINATE×2 | SCIEGEN PHARMS | ANDA 211657 | AB | May 20, 2019 | |
| SOLIFENACIN SUCCINATE×2 | WATSON LABS INC | ANDA 202551 | AB | May 20, 2019 | |
| SOLIFENACIN SUCCINATE×2 | TEVA PHARMS USA | ANDA 091464 | AB | Apr 02, 2014 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9918970 | May 18, 2031 | in 5 yr | Product |
Solifenacin succinate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
