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Last Updated: October 24, 2021

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Details for New Drug Application (NDA): 206353


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NDA 206353 describes EVOTAZ, which is a drug marketed by Bristol-myers Squibb and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EVOTAZ profile page.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the atazanavir sulfate; cobicistat profile page.
Summary for 206353
Tradename:EVOTAZ
Applicant:Bristol-myers Squibb
Ingredient:atazanavir sulfate; cobicistat
Patents:2
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 206353
Generic Entry Date for 206353*:
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: 206353
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EVOTAZ atazanavir sulfate; cobicistat TABLET;ORAL 206353 NDA E.R. Squibb & Sons, L.L.C. 0003-3641 0003-3641-11 30 TABLET in 1 BOTTLE (0003-3641-11)
Paragraph IV (Patent) Challenges for 206353
Tradename Dosage Ingredient NDA Submissiondate
EVOTAZ TABLET;ORAL atazanavir sulfate; cobicistat 206353 2017-09-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE;150MG
Approval Date:Jan 29, 2015TE:RLD:Yes
Patent:⤷  Free Forever TrialPatent Expiration:Oct 6, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Free Forever TrialPatent Expiration:Sep 3, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE

Expired US Patents for NDA 206353

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol-myers Squibb EVOTAZ atazanavir sulfate; cobicistat TABLET;ORAL 206353-001 Jan 29, 2015 ⤷  Free Forever Trial ⤷  Free Forever Trial
Bristol-myers Squibb EVOTAZ atazanavir sulfate; cobicistat TABLET;ORAL 206353-001 Jan 29, 2015 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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