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 nine patents protecting this drug and one Paragraph IV challenge.
This drug has three hundred and fifteen patent family members in forty-nine 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 sixteen 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: | 315 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 6 |
Patent Applications: | 122 |
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 Generic Entry Opportunity 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 nine US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of COMPLERA is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
HIV inhibiting pyrimidines derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION
HIV inhibiting pyrimidines derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION
Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION
Combinations of a pyrimidine containing NNRTI with RT inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION
Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION
Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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 | See Plans and Pricing | See Plans and Pricing |
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | See Plans and Pricing | See Plans and Pricing |
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | See Plans and Pricing | See Plans and Pricing |
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | See Plans and Pricing | See Plans and Pricing |
>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: See Plans and Pricing
Argentina
Patent: 4500
Estimated Expiration: See Plans and Pricing
Australia
Patent: 11329642
Estimated Expiration: See Plans and Pricing
Patent: 16208417
Estimated Expiration: See Plans and Pricing
Patent: 18202635
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2013012245
Estimated Expiration: See Plans and Pricing
Canada
Patent: 18097
Estimated Expiration: See Plans and Pricing
Chile
Patent: 13001402
Estimated Expiration: See Plans and Pricing
China
Patent: 3491948
Estimated Expiration: See Plans and Pricing
Patent: 6511357
Estimated Expiration: See Plans and Pricing
Colombia
Patent: 61300
Estimated Expiration: See Plans and Pricing
Costa Rica
Patent: 130293
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0140946
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 16115
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 40362
Estimated Expiration: See Plans and Pricing
Ecuador
Patent: 13012700
Estimated Expiration: See Plans and Pricing
Patent: 19078196
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 5852
Estimated Expiration: See Plans and Pricing
Patent: 1390651
Estimated Expiration: See Plans and Pricing
Patent: 1691695
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 40362
Estimated Expiration: See Plans and Pricing
Patent: 26466
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 90064
Estimated Expiration: See Plans and Pricing
Patent: 06592
Estimated Expiration: See Plans and Pricing
Israel
Patent: 6300
Estimated Expiration: See Plans and Pricing
Japan
Patent: 38851
Estimated Expiration: See Plans and Pricing
Patent: 14500261
Estimated Expiration: See Plans and Pricing
Patent: 15131853
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 7512
Estimated Expiration: See Plans and Pricing
Patent: 13005669
Estimated Expiration: See Plans and Pricing
Montenegro
Patent: 980
Estimated Expiration: See Plans and Pricing
Morocco
Patent: 735
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 0729
Estimated Expiration: See Plans and Pricing
Peru
Patent: 140163
Estimated Expiration: See Plans and Pricing
Patent: 170521
Estimated Expiration: See Plans and Pricing
Patent: 211657
Estimated Expiration: See Plans and Pricing
Poland
Patent: 40362
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 40362
Estimated Expiration: See Plans and Pricing
San Marino
Patent: 01400150
Estimated Expiration: See Plans and Pricing
Serbia
Patent: 691
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 0333
Estimated Expiration: See Plans and Pricing
Patent: 201509521W
Estimated Expiration: See Plans and Pricing
Patent: 201912527X
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 40362
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 1304481
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1923103
Estimated Expiration: See Plans and Pricing
Patent: 140037799
Estimated Expiration: See Plans and Pricing
Spain
Patent: 24408
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 56840
Estimated Expiration: See Plans and Pricing
Patent: 1238612
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 4075
Estimated Expiration: See Plans and Pricing
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 | 7300491 | See Plans and Pricing | |
Germany | 122005000041 | See Plans and Pricing | |
Taiwan | 201268 | See Plans and Pricing | |
Brazil | PI0414027 | combinações de uma pirimidina que contêm nnrti com inibidores de tr | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for COMPLERA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1632232 | 122016000111 | Germany | See Plans and Pricing | PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621 |
0915894 | 08C0020 | France | See Plans and Pricing | PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213 |
0513200 | SZ 7/2004 | Austria | See Plans and Pricing | |
1663240 | 93382 | Luxembourg | See Plans and Pricing | PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |