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Emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate - Generic Drug Details
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What are the generic sources for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate and what is the scope of freedom to operate?
Emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate has four hundred and fifty-six patent family members in fifty countries.
There are eighteen drug master file entries for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. Three suppliers are listed for this compound.
Summary for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
International Patents: | 456 |
US Patents: | 12 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 18 |
Suppliers / Packagers: | 3 |
Clinical Trials: | 10 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate |
DailyMed Link: | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate at DailyMed |
Recent Clinical Trials for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Janssen Pharmaceutical K.K. | Phase 4 |
Azienda Ospedaliera San Gerardo di Monza | Phase 4 |
Gilead Sciences | Phase 4 |
See all emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate clinical trials
Recent Litigation for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
Identify potential future generic entrants
District Court Litigation
Case Name | Date |
---|---|
GILEAD SCIENCES, INC. v. ZYDUS PHARMACEUTICALS (USA) INC. | 2019-01-15 |
GILEAD SCIENCES, INC. v. STRIDES PHARMA, INC. | 2018-06-27 |
Gilead Sciences, Inc. v. Aurobindo Pharma Ltd. | 2018-05-18 |
See all emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate litigation
PTAB Litigation
Petitioner | Date |
---|---|
Mylan Pharmaceuticals Inc. | 2014-06-04 |
See all emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate litigation
Pharmacology for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
COMPLERA | TABLET;ORAL | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | 202123 | 2015-05-20 |
US Patents and Regulatory Information for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
Expired US Patents for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
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 | Start Trial | Start Trial |
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | Start Trial | Start Trial |
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | Start Trial | Start Trial |
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | Start Trial | Start Trial |
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
Country | Patent Number | Estimated Expiration |
---|---|---|
Croatia | P20120265 | Start Trial |
Lithuania | PA2016045 | Start Trial |
Japan | 2015044839 | Start Trial |
Eurasian Patent Organization | 200501134 | Start Trial |
European Patent Office | 1419152 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1663240 | 300767 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN DIE BESCHERMD WORDT DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE, EN TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT; REGISTRATION NO/DATE: EU/1/11/737/001 20111128 |
1419152 | CA 2012 00019 | Denmark | Start Trial | |
0513200 | SZ 7/2004 | Austria | Start Trial | |
1663240 | C20150040 00167 | Estonia | Start Trial | PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA), TENOFOVIIR-;REG NO/DATE: EU/1/11/737/001-002 28.11.2011 |
1663240 | 2015/054 | Ireland | Start Trial | PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, AND TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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