COMPLERA Drug Patent Profile
✉ Email this page to a colleague
When do Complera patents expire, and when can generic versions of Complera launch?
Complera is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has three hundred and thirty-four patent family members in fifty-two countries.
The generic ingredient in COMPLERA is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.
DrugPatentWatch® Generic Entry Outlook for Complera
Complera was eligible for patent challenges on May 20, 2015.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 14, 2033. 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 COMPLERA
| International Patents: | 334 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Clinical Trials: | 6 |
| Patent Applications: | 119 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for COMPLERA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for COMPLERA |
| What excipients (inactive ingredients) are in COMPLERA? | COMPLERA excipients list |
| DailyMed Link: | COMPLERA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for COMPLERA
Generic Entry Date for COMPLERA*:
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 COMPLERA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Gilead Sciences | Phase 3 |
| CIHR Canadian HIV Trials Network | Phase 3 |
| Ottawa Hospital Research Institute | Phase 3 |
Pharmacology for COMPLERA
Anatomical Therapeutic Chemical (ATC) Classes for COMPLERA
Paragraph IV (Patent) Challenges for COMPLERA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| COMPLERA | Tablets | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | 200 mg/25 mg/ 300 mg | 202123 | 1 | 2015-05-20 |
US Patents and Regulatory Information for COMPLERA
COMPLERA is protected by seven US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of COMPLERA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting COMPLERA
Therapeutic compositions comprising rilpivirine HCL and tenofovir disoproxil fumarate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
HIV inhibiting pyrimidines derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV INFECTION
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV INFECTION
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV INFECTION
Combinations of a pyrimidine containing NNRTI with RT inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV INFECTION
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV INFECTION
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV INFECTION
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for COMPLERA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for COMPLERA
When does loss-of-exclusivity occur for COMPLERA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
African Regional IP Organization (ARIPO)
Patent: 16
Estimated Expiration: ⤷ Try a Trial
Argentina
Patent: 4500
Estimated Expiration: ⤷ Try a Trial
Patent: 3409
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 11329642
Estimated Expiration: ⤷ Try a Trial
Patent: 16208417
Estimated Expiration: ⤷ Try a Trial
Patent: 18202635
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2013012245
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 18097
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 13001402
Estimated Expiration: ⤷ Try a Trial
China
Patent: 3491948
Estimated Expiration: ⤷ Try a Trial
Patent: 6511357
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 61300
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 130293
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0140946
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 16115
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 40362
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 13012700
Estimated Expiration: ⤷ Try a Trial
Patent: 19078196
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 5852
Estimated Expiration: ⤷ Try a Trial
Patent: 1390651
Estimated Expiration: ⤷ Try a Trial
Patent: 1691695
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 40362
Estimated Expiration: ⤷ Try a Trial
Patent: 26466
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 90064
Estimated Expiration: ⤷ Try a Trial
Patent: 06592
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 6300
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 38851
Estimated Expiration: ⤷ Try a Trial
Patent: 14500261
Estimated Expiration: ⤷ Try a Trial
Patent: 15131853
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 5604
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 7512
Estimated Expiration: ⤷ Try a Trial
Patent: 13005669
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 980
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 735
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 0729
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 140163
Estimated Expiration: ⤷ Try a Trial
Patent: 170521
Estimated Expiration: ⤷ Try a Trial
Patent: 211657
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 40362
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 40362
Estimated Expiration: ⤷ Try a Trial
San Marino
Patent: 01400150
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 691
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 0333
Estimated Expiration: ⤷ Try a Trial
Patent: 201509521W
Estimated Expiration: ⤷ Try a Trial
Patent: 201912527X
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 40362
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1304481
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1923103
Estimated Expiration: ⤷ Try a Trial
Patent: 140037799
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 24408
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 56840
Estimated Expiration: ⤷ Try a Trial
Patent: 1238612
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 4075
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering COMPLERA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2019200813 | Combinations of a pyrimidine containing NNRTI with RT inhibitors | ⤷ Try a Trial |
| Lithuania | C1663240 | ⤷ Try a Trial | |
| Hong Kong | 1190064 | 含有鹽酸利匹韋林和富馬酸替諾福韋酯的治療組合物 (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRIN HCL AND TENOVOFIR DISOPROXIL FUMARATE) | ⤷ Try a Trial |
| Japan | 2008511591 | ⤷ Try a Trial | |
| Australia | 8582798 | ⤷ Try a Trial | |
| Hong Kong | 1079122 | Compositions and methods for combination antiviraltherapy | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for COMPLERA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0915894 | SPC021/2005 | Ireland | ⤷ Try a Trial | SPC021/2005: 20090811, EXPIRES: 20200220 |
| 1663240 | 1690061-5 | Sweden | ⤷ Try a 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 |
| 1663240 | 122015000085 | Germany | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
| 1663240 | 379 5033-2016 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: RILPIVIRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/TENOFOVIR-ALAFENAMID VO VSETKYCH FORMACH CHRA- NENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1112 20160623 |
| 1663240 | PA2015037,C1663240-2 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU PRIIMTINOS JO FORMOS, TOKIOS KAIP RILPIVIRINO DRUSKOS,ISKAITANT RILPIVIRINO HIDROCHLORIDA, TENOFOVIRO, YPAC TENOFOVIRO DIZOPROKSILIO FUMARATO, IR EMTRICITABINODERINYS; REGISTRATION NO/DATE: EU/1/11/737/001 2011-11-28, EU/1/11/737/002 20111128 |
| 1419152 | CR 2012 00021 | Denmark | ⤷ Try a 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - HIPAA-ready chat for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
