DrugPatentWatch Database Preview
COMPLERA Drug Profile
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 seventeen patents protecting this drug and one Paragraph IV challenge.
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 eighteen drug master file entries for this compound. Three 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: | 3 |
| 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.
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
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 |
International Patents for COMPLERA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 0513200 | ➤ Try a Free Trial |
| South Korea | 20080032014 | ➤ Try a Free Trial |
| Germany | 69130166 | ➤ Try a Free Trial |
| South Korea | 100860136 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for COMPLERA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2015000085 | Germany | ➤ Try a Free Trial | PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
| 4 5022-2015 | Slovakia | ➤ Try a Free Trial | PRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128 |
| C/GB04/016 | United Kingdom | ➤ Try a Free Trial | PRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024 |
| C0020 | France | ➤ Try a Free Trial | PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
