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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
UBS
Dow
Chubb
Healthtrust
Farmers Insurance
Johnson and Johnson
Baxter
Cerilliant
Daiichi Sankyo

Generated: October 20, 2017

DrugPatentWatch Database Preview

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 sixteen 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.

Summary for NDA: 202123

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:17
Formulation / Manufacturing:see details

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 Physicians Total Care, Inc. 54868-6360 54868-6360-0 30 TABLET, FILM COATED in 1 BOTTLE (54868-6360-0)
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;EQ 25MG BASE;300MG
Approval Date:Aug 10, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 13, 2016
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:► SubscribePatent Expiration:Jan 2, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Jan 25, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 202123

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

US Army
Harvard Business School
AstraZeneca
Healthtrust
Boehringer Ingelheim
Cantor Fitzgerald
Farmers Insurance
Citi
Federal Trade Commission
Fish and Richardson

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