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Details for New Drug Application (NDA): 208351

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NDA 208351 describes ODEFSEY, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the ODEFSEY profile page.

The generic ingredient in ODEFSEY is emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate profile page.

Suppliers and Packaging for NDA: 208351

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
TABLET;ORAL 208351 NDA Gilead Sciences, Inc. 61958-2101 61958-2101-1 30 TABLET in 1 BOTTLE, PLASTIC (61958-2101-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;EQ 25MG BASE;EQ 25MG BASE
Approval Date:Mar 1, 2016TE:RLD:Yes
Patent:5,814,639*PEDPatent Expiration:Mar 29, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:5,914,331*PEDPatent Expiration:Jan 2, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:6,642,245*PEDPatent Expiration:May 4, 2021Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 208351

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc
emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
TABLET;ORAL208351-001Mar 1, 20165,814,639*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.