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Serving 500+ biopharmaceutical companies globally:

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Generated: June 23, 2017

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Atazanavir sulfate - Generic Drug Details

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What are the generic drug sources for atazanavir sulfate and what is the scope of atazanavir sulfate freedom to operate?

Atazanavir sulfate
is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Teva Pharms Usa, and Bristol-myers Squibb, and is included in four NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Atazanavir sulfate has ninety-three patent family members in forty-two countries.

There are twenty-three drug master file entries for atazanavir sulfate. Five suppliers are listed for this compound. There are seven tentative approvals for this compound.

Summary for Generic Name: atazanavir sulfate

Tradenames:3
Patents:4
Applicants:3
NDAs:4
Drug Master File Entries: see list23
Suppliers / Packagers: see list5
Bulk Api Vendors: see list36
Clinical Trials: see list810
Patent Applications: see list34
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:atazanavir sulfate at DailyMed

Tentative approvals for ATAZANAVIR SULFATE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe300MG/100MGTABLET; ORAL
► Subscribe► Subscribe100MGCAPSULE; ORAL
► Subscribe► Subscribe200MGCAPSULE; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
ATAZANAVIR SULFATE
atazanavir sulfate
CAPSULE;ORAL091673-002Apr 22, 2014ABRXNoNo► Subscribe► Subscribe
Bristol-myers Squibb
EVOTAZ
atazanavir sulfate; cobicistat
TABLET;ORAL206353-001Jan 29, 2015RXYesYes6,087,383*PED► SubscribeY► Subscribe
Bristol Myers Squibb
REYATAZ
atazanavir sulfate
CAPSULE;ORAL021567-004Oct 16, 2006ABRXYesYes5,849,911*PED► SubscribeY► Subscribe
Bristol-myers Squibb
EVOTAZ
atazanavir sulfate; cobicistat
TABLET;ORAL206353-001Jan 29, 2015RXYesYes5,849,911*PED► SubscribeY► Subscribe
Teva Pharms Usa
ATAZANAVIR SULFATE
atazanavir sulfate
CAPSULE;ORAL091673-003Apr 22, 2014ABRXNoNo► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: atazanavir sulfate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,110,946 Antivirally active heterocyclic azahexane derivatives► Subscribe
6,300,519 Antivirally active heterocyclic azahexane derivatives► Subscribe
6,166,004 Combinations of HIV protease inhibitors with reverse transcriptase inhibitors► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: atazanavir sulfate

Country Document Number Estimated Expiration
Australia706183► Subscribe
European Patent Office1056722► Subscribe
Spain2178300► Subscribe
Argentina006720► Subscribe
Brazil9701877► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ATAZANAVIR SULFATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB05/036United Kingdom► SubscribeSPC/GB05/036: 20060206, EXPIRES: 20190301
2005 00037Denmark► Subscribe
C023/2005Ireland► SubscribeSPC023/2005, 20060612, EXPIRES: 20190301
0203Netherlands► Subscribe300203, 20170414, EXPIRES: 20190301
C0030France► SubscribePRODUCT NAME: ATAZANAVIR ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/03/267/001 DU 20040302; REGISTRATION NO/DATE AT EEC: EU/1/03/237/001 DU 20040302
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Baxter
Deloitte
McKinsey
Healthtrust
US Department of Justice
Teva
QuintilesIMS
McKesson
Argus Health
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 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.

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