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 patent protection?
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 seven 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 three hundred and thirty-four patent family members in fifty-two countries.
One supplier is listed for this compound.
Summary for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
International Patents: | 334 |
US Patents: | 7 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 11 |
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
Generic Entry Date for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate*:
Constraining patent/regulatory exclusivity:
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.
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
Pharmacology for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
COMPLERA | Tablets | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | 200 mg/25 mg/ 300 mg | 202123 | 1 | 2015-05-20 |
US Patents and Regulatory Information for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | ⤷ Try a Trial | ⤷ Try a 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 | Title | Estimated Expiration |
---|---|---|---|
Spain | 2542017 | ⤷ Try a Trial | |
Japan | 5820045 | ⤷ Try a Trial | |
Singapore | 10201912527X | THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1663240 | 300851 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623 |
1419152 | CR 2012 00019 | Denmark | ⤷ Try a Trial | PRODUCT NAME: RILPIVIRIN OG FARMACEUTISK ACCEPTABLE ADDITIONSSALTE DERAF, HERUNDER HYDROGENCHLORIDSALTET AF RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128 |
1663240 | PA2015038,C1663240-3 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU PRIIMTINOS JO FORMOS, TOKIOS KAIP RILPIVIRINO DRUSKOS,ISKAITANT RILPIVIRINO HIDROCHLORIDA, IR TENOFOVIRO, YPAC TENOFOVIRO DIZOPROKSILIO FUMARATO, DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28, EU/1/11/737/002 20111128 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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