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Last Updated: May 21, 2022

Details for New Drug Application (NDA): 204790


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NDA 204790 describes TIVICAY, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from three suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TIVICAY profile page.

The generic ingredient in TIVICAY is dolutegravir sodium. There are seventeen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.
Summary for 204790
Tradename:TIVICAY
Applicant:Viiv Hlthcare
Ingredient:dolutegravir sodium
Patents:2
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 204790
Generic Entry Date for 204790*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 204790
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIVICAY dolutegravir sodium TABLET;ORAL 204790 NDA ViiV Healthcare Company 49702-226 49702-226-13 30 TABLET, FILM COATED in 1 BOTTLE (49702-226-13)
TIVICAY dolutegravir sodium TABLET;ORAL 204790 NDA ViiV Healthcare Company 49702-227 49702-227-13 30 TABLET, FILM COATED in 1 BOTTLE (49702-227-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Aug 12, 2013TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Oct 5, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:See Plans and PricingPatent Expiration:Dec 8, 2029Product Flag?YSubstance Flag?YDelist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jun 9, 2016TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Oct 5, 2027Product Flag?YSubstance Flag?YDelist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.