Drug
Who makes tolvaptan?
9 companies list tolvaptan as a human prescription drug, including under the names Jynarque, SAMSCA. Forms: kit; tablet. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing tolvaptan
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| ASCEND Therapeutics US, LLC | kit; tablet | ANDAANDA211891, ANDA220147 | 13 | 0 |
| Otsuka America Pharmaceutical, Inc.Japan | kit; tablet | NDANDA022275, NDA204441 | 9 | 6 |
| Lupin LimitedIndia | kit; tablet | ANDAANDA216063 | 7 | 14 |
| Teva Pharmaceutical Industries Ltd.Canada | kit | ANDAANDA216933 | 5 | 6 |
| Apotex Inc.Canada | tablet | ANDAANDA207605 | 2 | 6 |
| Par Health USA, LLCIndia | tablet | ANDAANDA206119 | 2 | 5 |
| Camber Pharmaceuticals, Inc.United States | tablet | ANDAANDA205646 | 2 | 1 |
| Northstar Rx, LLC, | tablet | ANDAANDA216949 | 2 | 0 |
| Novadoz Pharmaceuticals LLC | tablet | ANDAANDA216949 | 2 | 0 |
Bulk ingredient listings
- MSN Laboratories Private Limited,India · 2 NDC
- Aurore Pharmaceuticals Private LimitedIndia · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- Jiangsu Hengrui Pharmaceuticals Co., Ltd.China · 1 NDC
- TYCHE INDUSTRIES LIMITEDIndia · 1 NDC
Orange Book patents
1 unexpired patent lists tolvaptan as the active ingredient, expiring between Apr 2030 and Apr 2030. Application holder: OTSUKA PHARMACEUTICAL CO LTD.
Enquiry
Common questions
- Who makes tolvaptan?
- 9 companies list tolvaptan as a human prescription drug in the openFDA NDC Directory, led by ASCEND Therapeutics US, LLC, Otsuka America Pharmaceutical, Inc., Lupin Limited, Teva Pharmaceutical Industries Ltd., Apotex Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Jynarque?
- 8 companies list tolvaptan under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies tolvaptan active ingredient?
- 5 companies list tolvaptan as a bulk ingredient, including MSN Laboratories Private Limited,, Aurore Pharmaceuticals Private Limited, Hetero Drugs Limited, Jiangsu Hengrui Pharmaceuticals Co., Ltd..