DrugPatentWatch Database Preview
COMPLERA Drug Profile
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When do Complera patents expire, and what generic alternatives are available?
This drug has five hundred and thirty-six patent family members in fifty-one countries.
The generic ingredient in COMPLERA is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There are seventeen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.
Summary for COMPLERA
| International Patents: | 536 |
| US Patents: | 17 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 8 |
| Formulation / Manufacturing: | see details |
| 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.
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 |
US Patents and Regulatory Information for COMPLERA
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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 Free Trial | ➤ Try a Free Trial |
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for COMPLERA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 200 mg/25 mg/300 mg | ➤ Subscribe | ➤ Try a Free Trial |
Non-Orange Book US Patents for COMPLERA
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 6,069,252 | Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers | ➤ Try a Free Trial |
| 7,402,588 | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane | ➤ Try a Free Trial |
| 5,700,937 | Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds | ➤ Try a Free Trial |
| RE38333 | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for COMPLERA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| India | 190780 | ➤ Try a Free Trial |
| Israel | 160328 | ➤ Try a Free Trial |
| Romania | 108564 | ➤ Try a Free Trial |
| Finland | 116222 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for COMPLERA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 008 | Luxembourg | ➤ Try a Free Trial | 92008, EXPIRES: 20261128 |
| 855 | Luxembourg | ➤ Try a Free Trial | 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 , TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL, ET L'EMTRICITABINE. |
| 2016000111 | Germany | ➤ Try a Free Trial | 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 |
| 2015037 | Lithuania | ➤ Try a Free Trial | PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001 2011 11 28, EU/1/11/737/002 20111128 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
