Tolvaptan - Generic Drug Details
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What are the generic sources for tolvaptan and what is the scope of patent protection?
Tolvaptan
is the generic ingredient in three branded drugs marketed by Otsuka, Alkem Labs Ltd, Apotex, Endo Operations, Hetero Labs Ltd V, and MSN, and is included in seven NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Tolvaptan has eighty-six patent family members in twenty-four countries.
There are eight drug master file entries for tolvaptan. Six suppliers are listed for this compound.
Summary for tolvaptan
International Patents: | 86 |
US Patents: | 2 |
Tradenames: | 3 |
Applicants: | 6 |
NDAs: | 7 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 101 |
Clinical Trials: | 93 |
Patent Applications: | 1,870 |
Drug Prices: | Drug price trends 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 Colorado, Denver | Phase 2 |
University of Maryland | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Msn | TOLVAPTAN | tolvaptan | TABLET;ORAL | 216949-002 | Jun 21, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Endo Operations | TOLVAPTAN | tolvaptan | TABLET;ORAL | 206119-001 | Feb 15, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-003 | May 19, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-004 | Apr 23, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-004 | Apr 23, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-004 | Apr 23, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for tolvaptan
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-002 | Apr 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-001 | May 19, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-005 | Apr 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-004 | Apr 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-001 | May 19, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-001 | Apr 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
International Patents for tolvaptan
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5893083 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2008156217 | ⤷ Sign Up | |
Japan | 2007091738 | METHOD OF MANUFACTURING BENZOAZEPIN COMPOUND OR ITS SALT | ⤷ Sign Up |
Spain | 2358217 | ⤷ Sign Up | |
European Patent Office | 2251319 | Procédés pour préparer des dérivés d' acide benzoïque (Process for preparing derivatives of benzoic acid) | ⤷ Sign Up |
Austria | E544744 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for tolvaptan
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0450097 | SPC/GB09/037 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TOLVAPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/09/539/001 20090803; UK EU/1/09/539/002 20090803; UK EU/1/09/539/003 20090803; UK EU/1/09/539/004 20090803 |
0450097 | C300408 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803 |
0450097 | 09C0049 | France | ⤷ Sign Up | PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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