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JULUCA Drug Profile
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» See Plans and PricingWhich patents cover Juluca, and what generic alternatives are available?
Juluca is a drug marketed by Viiv Hlthcare and is included in one NDA. There are seven patents protecting this drug.
This drug has four hundred and fifty-seven patent family members in fifty-three countries.
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.
US ANDA Litigation and Generic Entry Outlook for Juluca
Juluca was eligible for patent challenges on August 12, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 24, 2031. This may change due to patent challenges or generic licensing.
There have been seventeen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for JULUCA
| International Patents: | 457 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for JULUCA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JULUCA |
| DailyMed Link: | JULUCA at DailyMed |
Generic Entry Opportunity Date for JULUCA
Generic Entry Date for JULUCA*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Recent Clinical Trials for JULUCA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| ViiV Healthcare | Phase 1 |
| Janssen, LP | Phase 1 |
Recent Litigation for JULUCA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ViiV Healthcare Company v. Gilead Sciences, Inc. | 2018-02-07 |
| ViiV Healthcare Company v. Sandoz Inc. | 2017-12-11 |
| ViiV Healthcare Company v. Cipla Limited | 2017-12-04 |
Pharmacology for JULUCA
Synonyms for JULUCA
| Dolutegravir / rilpivirine |
| Dolutegravir and rilpivirine |
| Dolutegravir mixture with rilpivirine |
| S900007770 |
Paragraph IV (Patent) Challenges for JULUCA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| JULUCA | TABLET;ORAL | dolutegravir sodium; rilpivirine hydrochloride | 210192 | 2019-11-19 |
US Patents and Regulatory Information for JULUCA
Expired US Patents for JULUCA
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for JULUCA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Lithuania | 3284520 | Start Trial |
| Brazil | 112012018670 | Start Trial |
| Norway | 20071720 | Start Trial |
| Morocco | 29460 | Start Trial |
| Luxembourg | 92853 | Start Trial |
| Brazil | PI0514871 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for JULUCA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1419152 | CR 2012 00019 | Denmark | Start Trial | PRODUCT NAME: RILPIVIRIN OG FARMACEUTISK ACCEPTABLE ADDITIONSSALTE DERAF, HERUNDER HYDROGENCHLORIDSALTET AF RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128 |
| 1419152 | PA2012009,C1419152 | Lithuania | Start Trial | PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128 |
| 1874117 | C300676 | Netherlands | Start Trial | PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121 |
| 1419152 | CR 2012 00021 | Denmark | Start Trial | PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT ADDITIONSSALT AF RILPIVIRIN, HERUNDER HYDROCHLORID ADDITIONSSALTET AF RILPIVIRIN, OG TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128 |
| 1663240 | 1690061-5 | Sweden | Start Trial | PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623 |
| 1419152 | 122012000038 | Germany | Start Trial | PRODUCT NAME: KOMBINATION AUS RILPIVIRIN ODER EINER STEREOCHEMISCH ISOMEREN FORM ODER EINEM PHARMAZEUTISCH UNBEDENKLICHEN ADDITIONSSALZ DESSELBEN, EINSCHLIESSLICH DES CHLORWASSERSTOFFSAEURESALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT.; REGISTRATION NO/DATE: EU/1/11/737/001 20111128 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
