Juluca is a drug owned by Viiv Healthcare Co. It is protected by 11 US drug patents filed from 2018 to 2024. Out of these, 6 drug patents are active and 5 have expired. Juluca's patents have been open to challenges since 12 August, 2017. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 05, 2038. Details of Juluca's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US10426780 | Antiviral therapy |
Jan, 2031
(5 years from now) | Active |
| US9242986 | Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates |
Dec, 2029
(4 years from now) | Active |
| US8129385 | Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness |
Oct, 2027
(2 years from now) | Active |
| US7125879 | HIV inhibiting pyrimidines derivatives |
Apr, 2025
(2 months ago) |
Expired
|
| US8080551 | HIV inhibiting pyrimidines derivatives |
Apr, 2023
(2 years ago) |
Expired
|
| US6838464 | 2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents |
Feb, 2021
(4 years ago) |
Expired
|
| US7067522 | 2,4,DI (hetero-) arylamino (-oxy)-5-substituted pyrimidines as antineoplastic agents |
Dec, 2019
(5 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12011506 | Combination and uses and treatments thereof |
Sep, 2038
(13 years from now) | Active |
|
US9242986 (Pediatric) | Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates |
Jun, 2030
(4 years from now) | Active |
|
US8129385 (Pediatric) | Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness |
Apr, 2028
(2 years from now) | Active |
| US8101629 | Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile |
Aug, 2022
(2 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Juluca's patents.
Latest Legal Activities on Juluca's Patents
Given below is the list of recent legal activities going on the following patents of Juluca.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 22 Jan, 2024 | US8080551 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Aug, 2023 | US8129385 |
| Maintenance Fee Reminder Mailed Critical | 07 Aug, 2023 | US8080551 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Jul, 2023 | US8101629 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Jun, 2023 | US9242986 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Mar, 2023 | US10426780 |
| Withdrawal of Application for PTE Critical | 17 Jun, 2021 | US8080551 |
| Change in Power of Attorney (May Include Associate POA) Critical | 25 Mar, 2021 | US8080551 |
| Email Notification Critical | 25 Mar, 2021 | US8080551 |
| Correspondence Address Change Critical | 23 Mar, 2021 | US8080551 |
FDA has granted several exclusivities to Juluca. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Juluca, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Juluca.
Exclusivity Information
Juluca holds 2 exclusivities. All of its exclusivities have expired in 2020. Details of Juluca's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 12, 2018 |
| New Combination(NC) | Nov 21, 2020 |
Several oppositions have been filed on Juluca's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Juluca's generic, the next section provides detailed information on ongoing and past EP oppositions related to Juluca patents.
Juluca's Oppositions Filed in EPO
Juluca has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 09, 2012, by Hamm, Volker. This opposition was filed on patent number EP05108086A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17195280A | Feb, 2020 | Gilead Sciences, Inc. | Opposition rejected |
| EP16187411A | May, 2019 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP16187411A | May, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP16187411A | May, 2019 | Sandoz AG | Granted and Under Opposition |
| EP16187411A | May, 2019 | Cooke, Richard | Granted and Under Opposition |
| EP15164931A | Dec, 2018 | Cooke, Richard | Granted and Under Opposition |
| EP15164931A | Dec, 2018 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP16154531A | Dec, 2018 | Gilead Sciences, Inc. | Patent maintained as amended |
| EP06822311A | Nov, 2016 | Zwicker Schnappauf & Partner PartG mbB | Opposition procedure closed |
| EP11737484A | Feb, 2016 | Page White & Farrer Limited | Revoked |
| EP11737484A | Feb, 2016 | LEK Pharmaceuticals d.d. | Revoked |
| EP11737484A | Feb, 2016 | Ter Meer Steinmeister & Partner Patentanwälte mbB | Revoked |
| EP11737484A | Feb, 2016 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP04787096A | Jan, 2016 | Page White & Farrer Limited | Patent maintained as amended |
| EP06758843A | May, 2014 | Ahrens, Gabriele | Opposition procedure closed |
| EP05108086A | Feb, 2012 | Hamm, Volker | The patent has been limited |
US patents provide insights into the exclusivity only within the United States, but Juluca is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Juluca's family patents as well as insights into ongoing legal events on those patents.
Juluca's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Juluca's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 05, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Juluca Generics:
There are no approved generic versions for Juluca as of now.
How can I launch a generic of Juluca before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Juluca's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Juluca's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Juluca -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg/25 mg | 19 Nov, 2019 | 1 | 24 Jan, 2031 |
Alternative Brands for Juluca
Juluca which is used for managing HIV infection., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie |
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| Agouron Pharms |
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| Bristol Myers Squibb |
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| Gilead |
| |||||||||||||||
| Gilead Sciences |
| |||||||||||||||
| Gilead Sciences Inc |
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| Glaxosmithkline |
| |||||||||||||||
| Msd Sub Merck |
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| Viiv Hlthcare |
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About Juluca
Juluca is a drug owned by Viiv Healthcare Co. It is used for managing HIV infection. Juluca uses Dolutegravir Sodium; Rilpivirine Hydrochloride as an active ingredient. Juluca was launched by Viiv Hlthcare in 2017.
Approval Date:
Juluca was approved by FDA for market use on 21 November, 2017.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Juluca is 21 November, 2017, its NCE-1 date is estimated to be 12 August, 2017.
Active Ingredient:
Juluca uses Dolutegravir Sodium; Rilpivirine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Dolutegravir Sodium; Rilpivirine Hydrochloride ingredient
Treatment:
Juluca is used for managing HIV infection.
Dosage:
Juluca is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 50MG BASE;EQ 25MG BASE | TABLET | Prescription | ORAL |