COMPLERA Drug Patent Profile
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Which patents cover Complera, and what generic alternatives are available?
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
AI Research Assistant
Sample questions
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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: | 89 |
| 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
*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 |
|---|---|
| CIHR Canadian HIV Trials Network | Phase 3 |
| Ottawa Hospital Research Institute | Phase 3 |
| Gilead Sciences | Phase 3 |
Pharmacology 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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
HIV inhibiting pyrimidines derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV INFECTION
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV INFECTION
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV INFECTION
Combinations of a pyrimidine containing NNRTI with RT inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV INFECTION
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV INFECTION
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV INFECTION
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 | ⤷ Sign Up | ⤷ Sign Up |
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| >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
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷ Sign Up
Argentina
Patent: 4500
Patent: TABLETA MULTICAPA PARA TRATAR LA INFECCION POR HIV EN UN HUMANO
Estimated Expiration: ⤷ Sign Up
Patent: 3409
Patent: COMPOSICIONES TERAPÉUTICAS
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 11329642
Patent: Therapeutic compositions comprising rilpivirine HCl and tenofovir disoproxil fumarate
Estimated Expiration: ⤷ Sign Up
Patent: 16208417
Patent: Therapeutic compositions comprising rilpivirine HCl and tenofovir disoproxil fumarate
Estimated Expiration: ⤷ Sign Up
Patent: 18202635
Patent: Therapeutic compositions comprising rilpivirine HCl and tenofovir disoproxil fumarate
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2013012245
Patent: composições terapêuticas compreendendo hcl de rilpivirina e fumarato de tenofovir disoproxila
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 18097
Patent: COMPOSITIONS THERAPEUTIQUES COMPRENANT UN HYDROCHLORURE DE RILPIVIRINE ET UN FUMARATE DE TENOFOVIR DISOPROXIL (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 13001402
Patent: Un comprimido que comprende a) una primera capa comprendiendo rilpivirina hcl, sustancialmente exenta de fumarato de diisopropilo de tenofovir, b) una segunda capa comprendiendo fumarato de diisopropilo de tenofovir, sustancialmente exenta de rilpivirina hcl, y c) adicionalmente emtricitabina; y su uso para tratar una infeccion por vih.
Estimated Expiration: ⤷ Sign Up
China
Patent: 3491948
Patent: Therapeutic compositions comprising rilpivirine hcl and tenofovir disoproxil fumarate
Estimated Expiration: ⤷ Sign Up
Patent: 6511357
Patent: 包含利匹韦林HCl和富马酸替诺福韦酯的治疗组合物 (Therapeutic compositions comprising rilpivirine HCL and tenofovir disoproxil fumarate)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 61300
Patent: Composiciones terapéuticas que comprenden rilvipirina hcl y tenofovir disoproxil fumarato
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 130293
Patent: COMPOSICIONES TERAPÉUTICAS QUE COMPRENDEN RILPIVIRINA HCL Y TENOFOVIR DISOPROXIL FUMARATO
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0140946
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 16115
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 40362
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 13012700
Patent: COMPOSICIONES TERAPÉUTICAS QUE COMPRENDEN RILPIVIRINA HCL Y TENOFOVIR DISOPROXIL FUMARATO
Estimated Expiration: ⤷ Sign Up
Patent: 19078196
Patent: COMPOSICIONES TERAPÉUTICAS QUE COMPRENDEN RILPIVIRINA HCL Y TENOFOVIR DISOPROXIL FUMARATO
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 5852
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ РИЛПИВИРИН HCl И ТЕНОФОВИРА ДИЗОПРОКСИЛФУМАРАТ (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCl AND TENOFOVIR DISOPROXIL FUMARATE)
Estimated Expiration: ⤷ Sign Up
Patent: 1390651
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ РИЛПИВИРИН HCL И ТЕНОФОВИРА ДИЗОПРОКСИЛФУМАРАТ
Estimated Expiration: ⤷ Sign Up
Patent: 1691695
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ РИЛПИВИРИН HCL И ТЕНОФОВИРА ДИЗОПРОКСИЛФУМАРАТ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 40362
Patent: COMPOSITIONS THÉRAPEUTIQUES COMPRENANT UN HYDROCHLORURE DE LA RILPIVIRINE ET UN FUMARATE DE TÉNOFOVIR DISOPROXIL (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRIN HCL AND TENOVOFIR DISOPROXIL FUMARATE)
Estimated Expiration: ⤷ Sign Up
Patent: 26466
Patent: Compositions thérapeutiques comprenant du rilpivirin hcl et du ténofovir disoproxil fumarate (Therapeutic compositions comprising rilpivirin hcl and tenofovir disoproxil fumarate)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 90064
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Patent: 06592
Patent: 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 TENOFOVIR DISOPROXIL FUMARATE)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 6300
Patent: תכשירים טיפוליים המכילים רילפיבירין הידרוכלוריד ודנופוביר דיסאופרוקסיל פומאראט (Therapeutic compositions comprising rilpivirine hcl and tenofovir disoproxil fumarate)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 38851
Estimated Expiration: ⤷ Sign Up
Patent: 14500261
Estimated Expiration: ⤷ Sign Up
Patent: 15131853
Patent: リルピビリンＨＣｌおよびフマル酸テノホビルジソプロキシルを含有する治療用組成物 (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCl AND TENOFOVIR DISOPROXIL FUMARATE)
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 5604
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 7512
Patent: COMPOSICIONES TERAPEUTICAS QUE COMPRENDEN HCL DE RILPIVIRINA Y FUMARATO DE DISOPROXILO DE TENOFOVIR. (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE.)
Estimated Expiration: ⤷ Sign Up
Patent: 13005669
Patent: COMPOSICIONES TERAPEUTICAS QUE COMPRENDEN HCL DE RILPIVIRINA Y FUMARATO DE DISOPROXILO DE TENOFOVIR. (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 980
Patent: TERAPEUTSKE KOMPOZICIJE KOJE SADRŽE RILPIVIRIN HCL I TENOFOVIR DIZOPROKSIL FUMARAT (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 735
Patent: COMPOSITIONS THÉRAPEUTIQUES COMPRENANT UN HYDROCHLORURE DE RILPIVIRINE ET UN FUMARATE DE TÉNOFOVIR DISOPROXIL
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 0729
Patent: Therapeutic compositions comprising rilpivirine hcl and tenofovir disoproxil fumarate
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 140163
Patent: COMPOSICIONES TERAPEUTICAS QUE COMPRENDEN RILPIVIRINA HCL Y TENOFOVIR DISOPROXIL FUMARATO
Estimated Expiration: ⤷ Sign Up
Patent: 170521
Patent: COMBINACION FARMACEUTICA QUE COMPRENDE RILPIVIRINA HCL, TENOFOVIR DISOPROXIL FUMARATO Y EMTRICITABINA
Estimated Expiration: ⤷ Sign Up
Patent: 211657
Patent: COMPOSICIONES TERAPEUTICAS QUE COMPRENDEN RILPIVIRINA HCL Y TENOFOVIR DISOPROXIL FUMARATO
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 40362
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 40362
Estimated Expiration: ⤷ Sign Up
San Marino
Patent: 01400150
Patent: Composizioni terapeutiche comprendenti rilpivirinacloridrato e tenofovir disoproxil fumarato
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 691
Patent: TERAPEUTSKE KOMPOZICIJE KOJE SADRŽE RILPIVIRIN HCL I TENOVOFIR DIZOPROKSIL FUMARAT (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRIN HCL AND TENOVOFIR DISOPROXIL FUMARATE)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 0333
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷ Sign Up
Patent: 201509521W
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷ Sign Up
Patent: 201912527X
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 40362
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1304481
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1923103
Estimated Expiration: ⤷ Sign Up
Patent: 140037799
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 24408
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 56840
Estimated Expiration: ⤷ Sign Up
Patent: 1238612
Patent: Therapeutic compositions
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 4075
Patent: БАГАТОШАРОВА ТАБЛЕТКА, ЩО МІСТИТЬ РИЛПІВІРИН HCl, ЕМТРИЦИТАБІН І ТЕНОФОВІРУ ДИЗОПРОКСИЛФУМАРАТ
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Argentina | 084500 | TABLETA MULTICAPA PARA TRATAR LA INFECCION POR HIV EN UN HUMANO | ⤷ Sign Up |
| Japan | 3844978 | ⤷ Sign Up | |
| European Patent Office | 1772151 | ⤷ Sign Up | |
| Lithuania | PA2016045 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for COMPLERA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1419152 | C300532 | Netherlands | ⤷ Sign Up | PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE EN ELKE DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN,; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
| 1663240 | 1590057-4 | Sweden | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF RILPIVIRINE, OR A PHARMACEUTICAL LY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND TENOFOVIR DISOPROXIL, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737 20111128 |
| 1632232 | 122016000110 | Germany | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621 |
| 1632232 | SPC/GB17/007 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF RILPIVIRINE HYDROCHLORIDE AND TENOFOVIR ALAFENAMIDE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTERED: UK EU/1/16/1112 (NI) 20160623; UK PLGB 11972/0019 20160623 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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