Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Citi
Colorcon
Farmers Insurance
Covington
Healthtrust
Julphar
Boehringer Ingelheim
Argus Health

Generated: July 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202123

« Back to Dashboard

NDA 202123 describes COMPLERA, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from four 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. Four suppliers are listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.
Summary for 202123
Tradename:COMPLERA
Applicant:Gilead Sciences Inc
Ingredient:emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
Patents:17
Formulation / Manufacturing:see details
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 N 50090-1248-0
COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123 NDA Physicians Total Care, Inc. 54868-6360 E 54868-6360-0

Profile for product number 001

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

Expired US Patents for NDA 202123

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Express Scripts
Accenture
QuintilesIMS
Mallinckrodt
US Department of Justice
Merck
AstraZeneca
Farmers Insurance

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.