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Generated: November 20, 2018

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Details for New Drug Application (NDA): 202123

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NDA 202123 describes COMPLERA, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from three suppliers. There are seventeen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the COMPLERA profile page.

The generic ingredient in COMPLERA is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There are seventeen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.
Generic Entry Opportunity Date for 202123
Generic Entry Date for 202123*:
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.

Suppliers and Packaging for NDA: 202123
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123 NDA A-S Medication Solutions 50090-1248 50090-1248-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-1248-0)
COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123 NDA Gilead Sciences, Inc. 61958-1101 61958-1101-1 30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;EQ 25MG BASE;300MG
Approval Date:Aug 10, 2011TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jan 2, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jan 25, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jan 25, 2018Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 202123

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