EMTRIVA Drug Patent Profile
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When do Emtriva patents expire, and what generic alternatives are available?
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. Three 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: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 126 |
Clinical Trials: | 13 |
Patent Applications: | 4,636 |
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 |


Recent Clinical Trials for EMTRIVA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Alzheimer's Association | Phase 1 |
The Miriam Hospital | Phase 1 |
Brown University | Phase 1 |
Pharmacology for EMTRIVA
Drug Class | Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for EMTRIVA
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Gilead | EMTRIVA | emtricitabine | SOLUTION;ORAL | 021896-001 | Sep 28, 2005 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | 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 EMTRIVA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead | EMTRIVA | emtricitabine | SOLUTION;ORAL | 021896-001 | Sep 28, 2005 | See Plans and Pricing | See Plans and Pricing |
Gilead | EMTRIVA | emtricitabine | CAPSULE;ORAL | 021500-001 | Jul 2, 2003 | See Plans and Pricing | See Plans and Pricing |
Gilead | EMTRIVA | emtricitabine | SOLUTION;ORAL | 021896-001 | Sep 28, 2005 | See Plans and Pricing | See Plans and Pricing |
Gilead | EMTRIVA | emtricitabine | CAPSULE;ORAL | 021500-001 | Jul 2, 2003 | See Plans and Pricing | See Plans and Pricing |
Gilead | EMTRIVA | emtricitabine | CAPSULE;ORAL | 021500-001 | Jul 2, 2003 | See Plans and Pricing | See Plans and Pricing |
Gilead | EMTRIVA | emtricitabine | CAPSULE;ORAL | 021500-001 | Jul 2, 2003 | See Plans and Pricing | See Plans and Pricing |
Gilead | EMTRIVA | emtricitabine | SOLUTION;ORAL | 021896-001 | Sep 28, 2005 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EMTRIVA
See the table below for patents covering EMTRIVA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 1437292 | See Plans and Pricing | |
Norway | 970385 | See Plans and Pricing | |
Canada | 2105486 | NUCLEOSIDES THERAPEUTIQUES (THERAPEUTIC NUCLEOSIDES) | See Plans and Pricing |
Romania | 119365 | DERIVAŢI DE 1,3-OXATIOLAN, COMPOZIŢIE FARMACEUTICĂ ŞI METODĂ PENTRU TRATAREA INFECŢIEI HIV (1,3-OXATHIOLANE DERIVATIVES, PHARMACEUTICAL COMPOSITION AND METHOD FOR TREATING HIV INFECTIONS) | See Plans and Pricing |
Finland | 114915 | See Plans and Pricing | |
China | 1065065 | See Plans and Pricing | |
Canada | 2439322 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EMTRIVA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0582455 | SPC/GB08/022 | United Kingdom | See Plans and Pricing | PRODUCT NAME: A COMBINATION OF EFAVIRENZ, EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF, AND TENOFOVIR OR A PHARMACEUTICALLY ACCEPTABLE PRODRUG, SALT OR ESTER THEREOF, PARTICULARLY TENOFOVIR DISOPROXIL, ESPECIALLY TENOFOVIR DISOPROXIL FUMARATE; REGISTERED: UK EU/1/07/430/001 20071213 |
3150586 | 2020C/515 | Belgium | See Plans and Pricing | PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, IN HET BIJZONDER DARUNAVIR ETHANOLATE, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1225 20170925 |
3150586 | 132020000000055 | Italy | See Plans and Pricing | 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 | 15C0071 | France | See Plans and Pricing | 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 | 2015/053 | Ireland | See Plans and Pricing | 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 |
0582455 | 08C0021 | France | See Plans and Pricing | PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213 |
0915894 | 08C0020 | France | See Plans and Pricing | PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |