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.
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Questions you can ask:
- What is the 5 year forecast for EMTRIVA?
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Summary for EMTRIVA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 13 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Gilead | EMTRIVA | emtricitabine | SOLUTION;ORAL | 021896-001 | Sep 28, 2005 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | EMTRIVA | emtricitabine | CAPSULE;ORAL | 021500-001 | Jul 2, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | EMTRIVA | emtricitabine | SOLUTION;ORAL | 021896-001 | Sep 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | EMTRIVA | emtricitabine | SOLUTION;ORAL | 021896-001 | Sep 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | EMTRIVA | emtricitabine | SOLUTION;ORAL | 021896-001 | Sep 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | EMTRIVA | emtricitabine | SOLUTION;ORAL | 021896-001 | Sep 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | EMTRIVA | emtricitabine | CAPSULE;ORAL | 021500-001 | Jul 2, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Norway | 20083728 | ⤷ Sign Up | |
Norway | 970385 | ⤷ Sign Up | |
Portugal | 100198 | UTILIZACAO DE NUCLEOSIDO OXATIOLANO PARA A PREPARACAO DE COMPOSICOES PARA FINS TERAPEUTICOS | ⤷ Sign Up |
Norway | 2005015 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 9214743 | ⤷ Sign Up | |
Hungary | 227823 | PHARMACEUTICAL COMPOSITIONS COMPRISING 2-HYDROXYMETHYL-5-(5-FLUOROCYTOSIN-1-YL)-1,3-OXATHIOLANE AND FURTHER ANTIVIRAL AGENT | ⤷ Sign Up |
Japan | 2005053893 | METHOD AND COMPOSITION FOR SYNTHESIS OF BCH-189 RELATED COMPOUND | ⤷ Sign Up |
>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 | ⤷ Sign Up | 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 |
0513200 | 7/2004 | Austria | ⤷ Sign Up | PRODUCT NAME: EMTRICITABIN; NAT. REGISTRATION NO/DATE: EU/1/03/261/001- EU/1/03/261/003 20031024; FIRST REGISTRATION: EU EU/1/03/261/003 |
3150586 | 132020000000055 | Italy | ⤷ Sign Up | 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 |
3808743 | 301190 | Netherlands | ⤷ Sign Up | PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE OF EEN DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ADDITIEZOUT VAN RILPIVIRINE, MET INBEGRIP VAN HET HYDROCHLORIDE-ZOUT VAN RILPIVIRINE, EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
1632232 | 93385 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE CHLORHYDRATE DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, EMTRICITABINE, ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE |
3808743 | 2022C/531 | Belgium | ⤷ Sign Up | PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ADDITIEZOUT VAN RILPIVIRINE, EN EMTRICITABINE; AUTHORISATION NUMBER AND DATE: EU/1/11/737/001-002 20111128 |
0915894 | SPC/GB05/041 | United Kingdom | ⤷ Sign Up | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020. |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |