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Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022275


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NDA 022275 describes SAMSCA, which is a drug marketed by Otsuka America Pharm and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the SAMSCA profile page.

The generic ingredient in SAMSCA is tolvaptan. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tolvaptan profile page.
Summary for 022275
Tradename:SAMSCA
Applicant:Otsuka America Pharm
Ingredient:tolvaptan
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 022275
Suppliers and Packaging for NDA: 022275
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SAMSCA tolvaptan TABLET;ORAL 022275 NDA Otsuka America Pharmaceutical, Inc. 59148-020 59148-020-50 1 BLISTER PACK in 1 CARTON (59148-020-50) > 10 TABLET in 1 BLISTER PACK
SAMSCA tolvaptan TABLET;ORAL 022275 NDA Otsuka America Pharmaceutical, Inc. 59148-021 59148-021-50 1 BLISTER PACK in 1 CARTON (59148-021-50) > 10 TABLET in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 022275
Tradename Dosage Ingredient NDA Submissiondate
SAMSCA TABLET;ORAL tolvaptan 022275 2018-03-26
SAMSCA TABLET;ORAL tolvaptan 022275 2013-10-10
SAMSCA TABLET;ORAL tolvaptan 022275 2013-09-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:May 19, 2009TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 19, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPONATREMIA
Patent:  Start TrialPatent Expiration:Sep 1, 2026Product Flag?Substance Flag?YDelist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:May 19, 2009TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:May 19, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPONATREMIA

Expired US Patents for NDA 022275

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009   Start Trial   Start Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009   Start Trial   Start Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009   Start Trial   Start Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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