COMPLERA Drug Patent Profile
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When do Complera patents expire, 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
Questions you can ask:
- What is the 5 year forecast for COMPLERA?
- What are the global sales for COMPLERA?
- What is Average Wholesale Price for COMPLERA?
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 |
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
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 ⤷ Subscribe.
This potential generic entry date is based on patent 10,857,102.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Expired US Patents for COMPLERA
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: ⤷ Subscribe
Argentina
Patent: 4500
Patent: TABLETA MULTICAPA PARA TRATAR LA INFECCION POR HIV EN UN HUMANO
Estimated Expiration: ⤷ Subscribe
Patent: 3409
Patent: COMPOSICIONES TERAPÉUTICAS
Estimated Expiration: ⤷ Subscribe
Australia
Patent: 11329642
Patent: Therapeutic compositions comprising rilpivirine HCl and tenofovir disoproxil fumarate
Estimated Expiration: ⤷ Subscribe
Patent: 16208417
Patent: Therapeutic compositions comprising rilpivirine HCl and tenofovir disoproxil fumarate
Estimated Expiration: ⤷ Subscribe
Patent: 18202635
Patent: Therapeutic compositions comprising rilpivirine HCl and tenofovir disoproxil fumarate
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 2013012245
Patent: composições terapêuticas compreendendo hcl de rilpivirina e fumarato de tenofovir disoproxila
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
China
Patent: 3491948
Patent: Therapeutic compositions comprising rilpivirine hcl and tenofovir disoproxil fumarate
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Colombia
Patent: 61300
Patent: Composiciones terapéuticas que comprenden rilvipirina hcl y tenofovir disoproxil fumarato
Estimated Expiration: ⤷ Subscribe
Costa Rica
Patent: 130293
Patent: COMPOSICIONES TERAPÉUTICAS QUE COMPRENDEN RILPIVIRINA HCL Y TENOFOVIR DISOPROXIL FUMARATO
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0140946
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 16115
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 40362
Estimated Expiration: ⤷ Subscribe
Ecuador
Patent: 13012700
Patent: COMPOSICIONES TERAPÉUTICAS QUE COMPRENDEN RILPIVIRINA HCL Y TENOFOVIR DISOPROXIL FUMARATO
Estimated Expiration: ⤷ Subscribe
Patent: 19078196
Patent: COMPOSICIONES TERAPÉUTICAS QUE COMPRENDEN RILPIVIRINA HCL Y TENOFOVIR DISOPROXIL FUMARATO
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent: 1390651
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ РИЛПИВИРИН HCL И ТЕНОФОВИРА ДИЗОПРОКСИЛФУМАРАТ
Estimated Expiration: ⤷ Subscribe
Patent: 1691695
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ РИЛПИВИРИН HCL И ТЕНОФОВИРА ДИЗОПРОКСИЛФУМАРАТ
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Israel
Patent: 6300
Patent: תכשירים טיפוליים המכילים רילפיבירין הידרוכלוריד ודנופוביר דיסאופרוקסיל פומאראט (Therapeutic compositions comprising rilpivirine hcl and tenofovir disoproxil fumarate)
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 38851
Estimated Expiration: ⤷ Subscribe
Patent: 14500261
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Malaysia
Patent: 5604
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Morocco
Patent: 735
Patent: COMPOSITIONS THÉRAPEUTIQUES COMPRENANT UN HYDROCHLORURE DE RILPIVIRINE ET UN FUMARATE DE TÉNOFOVIR DISOPROXIL
Estimated Expiration: ⤷ Subscribe
New Zealand
Patent: 0729
Patent: Therapeutic compositions comprising rilpivirine hcl and tenofovir disoproxil fumarate
Estimated Expiration: ⤷ Subscribe
Peru
Patent: 140163
Patent: COMPOSICIONES TERAPEUTICAS QUE COMPRENDEN RILPIVIRINA HCL Y TENOFOVIR DISOPROXIL FUMARATO
Estimated Expiration: ⤷ Subscribe
Patent: 170521
Patent: COMBINACION FARMACEUTICA QUE COMPRENDE RILPIVIRINA HCL, TENOFOVIR DISOPROXIL FUMARATO Y EMTRICITABINA
Estimated Expiration: ⤷ Subscribe
Patent: 211657
Patent: COMPOSICIONES TERAPEUTICAS QUE COMPRENDEN RILPIVIRINA HCL Y TENOFOVIR DISOPROXIL FUMARATO
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 40362
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 40362
Estimated Expiration: ⤷ Subscribe
San Marino
Patent: 01400150
Patent: Composizioni terapeutiche comprendenti rilpivirinacloridrato e tenofovir disoproxil fumarato
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Singapore
Patent: 0333
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷ Subscribe
Patent: 201509521W
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷ Subscribe
Patent: 201912527X
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 40362
Estimated Expiration: ⤷ Subscribe
South Africa
Patent: 1304481
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1923103
Estimated Expiration: ⤷ Subscribe
Patent: 140037799
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 24408
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 56840
Estimated Expiration: ⤷ Subscribe
Patent: 1238612
Patent: Therapeutic compositions
Estimated Expiration: ⤷ Subscribe
Ukraine
Patent: 4075
Patent: БАГАТОШАРОВА ТАБЛЕТКА, ЩО МІСТИТЬ РИЛПІВІРИН HCl, ЕМТРИЦИТАБІН І ТЕНОФОВІРУ ДИЗОПРОКСИЛФУМАРАТ
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
South Korea | 20130127515 | COMBINATIONS OF A PYRIMIDINE CONTAINING NNRTI WITH RT INHIBITORS | ⤷ Subscribe |
Portugal | 100151 | 2-HIDROXI-METIL-5-(5-FLUOROCITOSIN-1-IL)-1,3-OXATIOLANO E SEUS DERIVADOS COM ACTIVIDADE ANTI-VIRAL E PROCESSO PARA A SUA PREPARACAO | ⤷ Subscribe |
Hong Kong | 1206592 | 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) | ⤷ Subscribe |
Ireland | 920701 | ⤷ Subscribe | |
China | 1416423 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for COMPLERA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0915894 | SPC018/2008 | Ireland | ⤷ Subscribe | SPC018/2008: 20090811, EXPIRES: 20220724 |
1632232 | 93385 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: COMBINAISON DE CHLORHYDRATE DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, EMTRICITABINE, ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE |
1663240 | PA2015038 | Lithuania | ⤷ Subscribe | PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28, EU/1/11/737/002 20111128 |
1419152 | 1290017-1 | Sweden | ⤷ Subscribe | PRODUCT NAME: RILPIVIRIN OCH FARMACEUTISKT GODTAGBARA ADDITIONSSALTER DAERAV, INBEGRIPET VAETEKLORSYRASALTET AV RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128 |
1663240 | CA 2015 00055 | Denmark | ⤷ Subscribe | PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF, SOM ER BESKYTTET AF GRUNDPATENTET, SASOM ET FARMECEUTISK ACCEPTABELT SALT AF RILPIVIRIN, HERUNDER HYDROCHLORIDSALTET AF RILPIVIRIN, TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
COMPLERA Market Analysis and Financial Projection Experimental
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