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Last Updated: December 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203100

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NDA 203100 describes STRIBILD, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from four suppliers. There are thirteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the STRIBILD profile page.

The generic ingredient in STRIBILD is cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 203100
Generic Entry Opportunity Date for 203100
Generic Entry Date for 203100*:
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: 203100
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100 NDA A-S Medication Solutions 50090-1318 50090-1318-0 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1318-0)
STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100 NDA State of Florida DOH Central Pharmacy 53808-0887 53808-0887-1 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0887-1)
Paragraph IV (Patent) Challenges for 203100
Tradename Dosage Ingredient NDA Submissiondate
STRIBILD TABLET;ORAL cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate 203100 2018-10-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG;150MG;200MG;300MG
Approval Date:Aug 27, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 27, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:  Start TrialPatent Expiration:Oct 4, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:May 4, 2021Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 203100

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