FDA Orange Book · active-ingredient family
Tolvaptan
Tolvaptan is approved as 2 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:JYNARQUE · NDA 204441
2
Brand (NDA)
8
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| JYNARQUERLD×5 | OTSUKA | NDA 204441 | AB2 | Apr 23, 2018 | |
| SAMSCARLD×3 | OTSUKA | NDA 022275 | AB1 | May 19, 2009 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TOLVAPTAN×5 | ALKEM LABS LTD | ANDA 220147 | AB2 | Apr 21, 2026 | |
| TOLVAPTAN×5 | APOTEX | ANDA 218381 | AB2 | Nov 10, 2025 | |
| TOLVAPTAN×5 | LUPIN | ANDA 216063 | AB2 | Apr 23, 2025 | |
| TOLVAPTAN×2 | MSN | ANDA 216949 | AB1 | Jun 21, 2023 | |
| TOLVAPTAN×3 | ALKEM LABS LTD | ANDA 211891 | AB1 | Sep 06, 2022 | |
| TOLVAPTAN×2 | APOTEX | ANDA 207605 | AB1 | Sep 06, 2022 | |
| TOLVAPTAN×2 | HETERO LABS LTD V | ANDA 205646 | AB1 | Sep 06, 2022 | |
| TOLVAPTAN×2 | PH HEALTH | ANDA 206119 | AB1 | Feb 15, 2022 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8501730 | Sep 01, 2026 | in 2 mo | Substance |
| 10905694 | Apr 07, 2030 | in 3 yr 10 mo | Product |
Tolvaptan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
