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Last Updated: August 7, 2020

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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 one supplier. 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. One supplier is 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 Gilead Sciences, Inc. 61958-1201 61958-1201-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1201-1)
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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Merck
Dow
Colorcon
Boehringer Ingelheim
Johnson and Johnson

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 verification 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.