You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 210192


✉ Email this page to a colleague

« Back to Dashboard


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 four 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:4
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE;EQ 25MG BASE
Approval Date:Nov 21, 2017TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jan 24, 2031Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HIV INFECTION
Patent:⤷  Try a TrialPatent Expiration:Apr 21, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HIV INFECTION
Patent:⤷  Try a TrialPatent Expiration:Apr 5, 2028Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 210192

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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.