TOLVAPTAN Drug Patent Profile
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Which patents cover Tolvaptan, and what generic alternatives are available?
Tolvaptan is a drug marketed by Alkem Labs Ltd, Apotex, Endo Operations, Hetero Labs Ltd V, and MSN. and is included in five NDAs.
The generic ingredient in TOLVAPTAN is tolvaptan. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tolvaptan profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tolvaptan
A generic version of TOLVAPTAN was approved as tolvaptan by ALKEM LABS LTD on May 19th, 2020.
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Questions you can ask:
- What is the 5 year forecast for TOLVAPTAN?
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Summary for TOLVAPTAN
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 101 |
| Clinical Trials: | 93 |
| Patent Applications: | 1,174 |
| Drug Prices: | Drug price information for TOLVAPTAN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TOLVAPTAN |
| What excipients (inactive ingredients) are in TOLVAPTAN? | TOLVAPTAN excipients list |
| DailyMed Link: | TOLVAPTAN at DailyMed |
Recent Clinical Trials for TOLVAPTAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Medical Center Groningen | Phase 3 |
| University of Maryland | Phase 2 |
| University of Colorado, Denver | Phase 2 |
Pharmacology for TOLVAPTAN
| Drug Class | Vasopressin V2 Receptor Antagonist |
| Mechanism of Action | Vasopressin V2 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for TOLVAPTAN
Paragraph IV (Patent) Challenges for TOLVAPTAN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| JYNARQUE | Tablets | tolvaptan | 15 mg, 30 mg, 45 mg, 60 mg, 90 mg | 204441 | 1 | 2021-04-08 |
| SAMSCA | Tablets | tolvaptan | 60 mg | 022275 | 1 | 2018-03-26 |
| SAMSCA | Tablets | tolvaptan | 15 mg | 022275 | 1 | 2013-10-10 |
| SAMSCA | Tablets | tolvaptan | 30mg | 022275 | 1 | 2013-09-23 |
US Patents and Regulatory Information for TOLVAPTAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alkem Labs Ltd | TOLVAPTAN | tolvaptan | TABLET;ORAL | 211891-003 | Sep 6, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Endo Operations | TOLVAPTAN | tolvaptan | TABLET;ORAL | 206119-002 | Feb 15, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | TOLVAPTAN | tolvaptan | TABLET;ORAL | 207605-002 | Sep 6, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hetero Labs Ltd V | TOLVAPTAN | tolvaptan | TABLET;ORAL | 205646-002 | Sep 6, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alkem Labs Ltd | TOLVAPTAN | tolvaptan | TABLET;ORAL | 211891-001 | May 19, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alkem Labs Ltd | TOLVAPTAN | tolvaptan | TABLET;ORAL | 211891-002 | May 19, 2020 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for TOLVAPTAN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Otsuka Pharmaceutical Netherlands B.V. | Jinarc | tolvaptan | EMEA/H/C/002788 Jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease. |
Authorised | no | no | no | 2015-05-27 | |
| Otsuka Pharmaceutical Netherlands B.V. | Samsca | tolvaptan | EMEA/H/C/000980 Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH)., |
Authorised | no | no | no | 2009-08-02 | |
| Accord Healthcare S.L.U. | Tolvaptan Accord | tolvaptan | EMEA/H/C/005961 Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH). |
Authorised | yes | no | no | ||
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
