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COMPLERA Drug Profile
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See Plans and PricingWhen 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 twelve patents protecting this drug and one Paragraph IV challenge.
This drug has four hundred and fifty-six patent family members in fifty countries.
The generic ingredient in COMPLERA is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.
US ANDA Litigation and 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 December 9, 2025. This may change due to patent challenges or generic licensing.
There have been twenty 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: | 456 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 8 |
| Patent Applications: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for COMPLERA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for COMPLERA |
| DailyMed Link: | COMPLERA at DailyMed |
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 |
| Ottawa Hospital Research Institute | Phase 3 |
| CIHR Canadian HIV Trials Network | Phase 3 |
Recent Litigation for COMPLERA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| United States v. Gilead Sciences, Inc. | 2019-11-06 |
| GILEAD SCIENCES, INC. v. ZYDUS PHARMACEUTICALS (USA) INC. | 2019-01-15 |
| GILEAD SCIENCES, INC. v. STRIDES PHARMA, INC. | 2018-06-27 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| 2014-06-04 | |
| Mylan Pharmaceuticals Inc. | 2014-06-04 |
Pharmacology for COMPLERA
Synonyms for COMPLERA
| 1436864-99-1 |
| DQEFVRYFVZNIMK-FEDPJRJMSA-N |
| Emtricitabine / rilpivirine / tenofovir disoproxil fumarate |
| Emtricitabine mixture with rilpivirine and tenofovir disoproxil fumarate |
| Emtricitabine, rilpivirine, tenofovir mixture |
| Eviplera |
Paragraph IV (Patent) Challenges for COMPLERA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| COMPLERA | TABLET;ORAL | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | 202123 | 2015-05-20 |
US Patents and Regulatory Information for COMPLERA
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 | Start Trial | Start Trial |
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | Start Trial | Start Trial |
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | Start Trial | Start Trial |
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | Start Trial | Start Trial |
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for COMPLERA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1278735 | Start Trial |
| New Zealand | 545306 | Start Trial |
| Canada | 2678778 | Start Trial |
| European Patent Office | 1439177 | Start Trial |
| European Patent Office | 0574487 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for COMPLERA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1663240 | 15C0071 | France | Start Trial | PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
| 1663240 | 1690062-3 | Sweden | Start Trial | PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623 |
| 1419152 | 2012C/020 | Belgium | Start Trial | PRODUCT NAME: RILPIVIRINE; AUTHORISATION NUMBER AND DATE: EU/1/11/736/001 20111130 |
| 1663240 | CA 2016 00064 | Denmark | Start Trial | PRODUCT NAME: RILPIVIRINHYDROCHLORID, EMTRICITABIN OG TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623 |
| 1663240 | C20150039 00166 | Estonia | Start Trial | PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA) JA EMTRITSITABIINI;REG NO/DATE: EU/1/11/737/001-002 28.11.2011 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
