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Last Updated: March 8, 2021

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Details for New Drug Application (NDA): 210192

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NDA 210192 describes JULUCA, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the JULUCA profile page.

The generic ingredient in JULUCA is dolutegravir sodium; rilpivirine hydrochloride. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dolutegravir sodium; rilpivirine hydrochloride profile page.
Summary for 210192
Tradename:JULUCA
Applicant:Viiv Hlthcare
Ingredient:dolutegravir sodium; rilpivirine hydrochloride
Patents:7
Generic Entry Opportunity Date for 210192
Generic Entry Date for 210192*:
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: 210192
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192 NDA ViiV Healthcare Company 49702-242 49702-242-13 30 TABLET, FILM COATED in 1 BOTTLE (49702-242-13)
Paragraph IV (Patent) Challenges for 210192
Tradename Dosage Ingredient NDA Submissiondate
JULUCA TABLET;ORAL dolutegravir sodium; rilpivirine hydrochloride 210192 2019-11-19

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE;EQ 25MG BASE
Approval Date:Nov 21, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 21, 2020
Regulatory Exclusivity Use:NEW COMBINATION
Patent:  Start TrialPatent Expiration:Jan 24, 2031Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HIV INFECTION
Patent:  Start TrialPatent Expiration:Feb 26, 2021Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 210192

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017   Start Trial   Start Trial
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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