EMTRIVA Drug Patent Profile
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Which patents cover Emtriva, and when can generic versions of Emtriva launch?
Emtriva is a drug marketed by Gilead and is included in two NDAs.
The generic ingredient in EMTRIVA is emtricitabine. There are eighteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the emtricitabine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Emtriva
A generic version of EMTRIVA was approved as emtricitabine by CIPLA on July 2nd, 2018.
Summary for EMTRIVA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 139 |
Clinical Trials: | 13 |
Patent Applications: | 5,194 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for EMTRIVA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EMTRIVA |
What excipients (inactive ingredients) are in EMTRIVA? | EMTRIVA excipients list |
DailyMed Link: | EMTRIVA at DailyMed |
Paragraph IV (Patent) Challenges for EMTRIVA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EMTRIVA | Capsules | emtricitabine | 200 mg | 021500 | 1 | 2012-07-16 |
US Patents and Regulatory Information for EMTRIVA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead | EMTRIVA | emtricitabine | CAPSULE;ORAL | 021500-001 | Jul 2, 2003 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Gilead | EMTRIVA | emtricitabine | SOLUTION;ORAL | 021896-001 | Sep 28, 2005 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 EMTRIVA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead | EMTRIVA | emtricitabine | CAPSULE;ORAL | 021500-001 | Jul 2, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead | EMTRIVA | emtricitabine | SOLUTION;ORAL | 021896-001 | Sep 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead | EMTRIVA | emtricitabine | CAPSULE;ORAL | 021500-001 | Jul 2, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead | EMTRIVA | emtricitabine | SOLUTION;ORAL | 021896-001 | Sep 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead | EMTRIVA | emtricitabine | SOLUTION;ORAL | 021896-001 | Sep 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for EMTRIVA
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Ireland UC | Emtriva | emtricitabine | EMEA/H/C/000533 Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens.When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate. |
Authorised | no | no | no | 2003-10-24 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for EMTRIVA
See the table below for patents covering EMTRIVA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 4031995 | ⤷ Try a Trial | |
Canada | 2105486 | NUCLEOSIDES THERAPEUTIQUES (THERAPEUTIC NUCLEOSIDES) | ⤷ Try a Trial |
Norway | 20065640 | ⤷ Try a Trial | |
Romania | 108564 | DERIVATI DE NUCLEOZIDE, PROCEDEU DE OBTINERE A LOR SI INTERMEDIARI PENTRU ACESTIA (NUCLEOSIDASE DERIVATES, PREPARATION PROCESS AND INTERMEDIARIES THEREFOR) | ⤷ Try a Trial |
Australia | 665187 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EMTRIVA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1663240 | 15C0071 | France | ⤷ Try a 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 |
3150586 | 132020000000055 | Italy | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, DARUNAVIR O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO, E EMTRICITABINE O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO(SYMTUZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1225, 20170925 |
1663240 | 2015/053 | Ireland | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
1663240 | 1590057-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF RILPIVIRINE, OR A PHARMACEUTICAL LY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND TENOFOVIR DISOPROXIL, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737 20111128 |
0915894 | SPC/GB08/033 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |