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Last Updated: December 2, 2022

Tolvaptan - Generic Drug Details


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What are the generic drug sources for tolvaptan and what is the scope of freedom to operate?

Tolvaptan is the generic ingredient in three branded drugs marketed by Otsuka, Alkem Labs Ltd, Apotex, Hetero Labs Ltd V, and Par Pharm Inc, and is included in six 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. Five suppliers are listed for this compound.

Recent Clinical Trials for tolvaptan

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University Medical Center GroningenPhase 3
University of MarylandPhase 2
University of Colorado, DenverPhase 2

See all tolvaptan clinical trials

Pharmacology 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
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-004 Apr 23, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-005 Apr 23, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-005 Apr 23, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-002 Apr 23, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Alkem Labs Ltd TOLVAPTAN tolvaptan TABLET;ORAL 211891-001 May 19, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-003 Apr 23, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hetero Labs Ltd V TOLVAPTAN tolvaptan TABLET;ORAL 205646-002 Sep 6, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 See Plans and Pricing See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-002 Apr 23, 2018 See Plans and Pricing See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-002 Apr 23, 2018 See Plans and Pricing See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-003 Apr 23, 2018 See Plans and Pricing See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-001 Apr 23, 2018 See Plans and Pricing See Plans and Pricing
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 See Plans and Pricing See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-003 Apr 23, 2018 See Plans and Pricing See Plans and Pricing
>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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for tolvaptan

Country Patent Number Title Estimated Expiration
Spain 2527794 See Plans and Pricing
Denmark 2167046 See Plans and Pricing
Japan 2012197295 PROCESS FOR PREPARING BENZOAZEPINE COMPOUND OR SALT THEREOF See Plans and Pricing
Spain 2354030 See Plans and Pricing
Japan 2012176979 METHOD FOR PREPARING BENZAZEPINE COMPOUND OR SALT THEREOF See Plans and Pricing
Spain 2379153 See Plans and Pricing
Spain 2358217 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tolvaptan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0450097 C300408 Netherlands See Plans and Pricing PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803
0450097 09C0049 France See Plans and Pricing PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
0450097 SPC/GB09/037 United Kingdom See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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