FDA Orange Book
Generic for Samsca
Samsca contains tolvaptan. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Samsca is tolvaptan. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
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Samsca products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 15MG | Marketed (Rx) | AB1 | 9 | AB1, AB2 |
| tablet, oral | 30MG | Marketed (Rx) | AB1 | 9 | AB1, AB2 |
| tablet, oral | 60MG | Discontinued | None | 5 | AB2 |
NDA 022275, held by OTSUKA PHARMACEUTICAL CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tolvaptan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 206119 | AB1 (A-rated, therapeutically equivalent) | February 15, 2022 | 15MG, 30MG |
| ALKEM LABORATORIES LTD | 211891 | AB1 (A-rated, therapeutically equivalent) | September 6, 2022 | 15MG, 30MG, 60MG |
| APOTEX INC | 207605 | AB1 (A-rated, therapeutically equivalent) | September 6, 2022 | 15MG, 30MG |
| HETERO LABS LTD UNIT V | 205646 | AB1 (A-rated, therapeutically equivalent) | September 6, 2022 | 15MG, 30MG |
| MSN LABORATORIES PRIVATE LTD | 216949 | AB1 (A-rated, therapeutically equivalent) | June 21, 2023 | 15MG, 30MG |
| LUPIN LTD | 216063 | AB2 (A-rated, therapeutically equivalent) | April 23, 2025 | 15MG, 30MG, 60MG |
| APOTEX INC | 218381 | AB2 (A-rated, therapeutically equivalent) | November 10, 2025 | 15MG, 30MG, 60MG |
| ALKEM LABORATORIES LTD | 220147 | AB2 (A-rated, therapeutically equivalent) | April 21, 2026 | 15MG, 30MG, 60MG |
| TEVA PHARMACEUTICALS INC | 216933 | AB2 (A-rated, therapeutically equivalent) | July 21, 2026 | 15MG, 30MG, 60MG |
Samsca patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8501730 | September 1, 2026 | Drug substance | None | 022275 |
| 10905694 | April 7, 2030 | Drug product | None | 022275 |
Samsca NDC codes
Questions
Is there a generic for Samsca?
Yes. The generic name for Samsca is tolvaptan. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
What is the generic name for Samsca?
The active ingredient in Samsca is tolvaptan, per the FDA Orange Book.
When does the Samsca patent expire?
The last patent listed for Samsca in the Orange Book expires April 7, 2030. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.