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Atazanavir sulfate - Generic Drug Details

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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 three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has ninety-three patent family members in forty-two countries.

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

Summary for Generic Name: atazanavir sulfate

Tradenames:3
Patents:3
Applicants:3
NDAs:4
Drug Master File Entries: see list22
Suppliers / Packaging: see list4
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices

Tentative approvals for ATAZANAVIR SULFATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL300MG/100MG
<disabled><disabled>CAPSULE; ORAL100MG
<disabled><disabled>CAPSULE; ORAL150MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol-myers Squibb
EVOTAZ
atazanavir sulfate; cobicistat
TABLET;ORAL206353-001Jan 29, 2015RXYes6,087,383*PED► subscribeY► subscribe
Bristol Myers Squibb
REYATAZ
atazanavir sulfate
CAPSULE;ORAL021567-003Jun 20, 2003RXNo6,087,383*PED► subscribeY► subscribe
Bristol Myers Squibb
REYATAZ
atazanavir sulfate
CAPSULE;ORAL021567-002Jun 20, 2003RXNo5,849,911*PED► subscribeY► 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
6,300,519 Antivirally active heterocyclic azahexane derivatives► subscribe
6,110,946 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
Lithuania4780► subscribe
European Patent Office1056722► subscribe
Slovenia0900210► 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
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
2005 00037Denmark► subscribe
0900210/01Switzerland► subscribePRODUCT NAME: ATAZANAVIR; REGISTRATION NUMBER/DATE: SWISSMEDIC 56288 06.05.2004
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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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