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Last Updated: June 4, 2020

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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?

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
Colorcon
Harvard Business School
Express Scripts
Mallinckrodt

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.