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Generated: September 23, 2018

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Atazanavir sulfate - Generic Drug Details

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What are the generic 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 Aurobindo Pharma Ltd, Cipla Ltd, Teva Pharms Usa, Bristol Myers Squibb, and Bristol-myers Squibb, and is included in six NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

Medical Subject Heading (MeSH) Categories for atazanavir sulfate
Synonyms for atazanavir sulfate
111996-EP2272516A2
111996-EP2298761A1
111996-EP2298783A1
2,5,6,10,13-Pentaazatetradecanedioic acid, 3-12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-((-4-(2-pyridinyl)phenyl)methyl)-, dimethyl ester, (3S,8S,9S,12S)-, sulfate (1:1) (salt)
2,5,6,10,13-Pentaazatetradecanedioic acid, 3,12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-((4-(2-pyridinyl)phenyl)methyl)-, dimethyl ester, (3S,8S,9S,12S)-, sulfate (1:1) (salt)
229975-97-7
4MT4VIE29P
975A977
AB0015721
AC1L4K4Y
AK-97253
AKOS016000176
AM020583
AOB5599
AS-14954
Atazanavir (sulfate)
Atazanavir sulfate (BMS-232632-05)
Atazanavir sulfate (JAN/USAN)
Atazanavir sulfate [USAN]
Atazanavir sulphate
atazanavir; sulfuric acid
Atazanavirsulfate
BC677640
BMS-232632-05
C38H52N6O7.H2SO4
CHEBI:31243
CHEMBL1200678
CS-1890
D01276
Dimethyl (3S,8S,9S,12S)-9-benzyl-3,12,di-tert-butyl-8-hydroxy-4,11-dioxo-6-(p-2-pyridylbenzyl)-2,5,6,10,13-pentaazatetradecanedioate, sulfate (1:1) (salt)
DQSGVVGOPRWTKI-QVFAWCHISA-N
FT-0662312
HE073604
HY-17367A
J-014934
KS-00000FO1
LS-186585
methyl ((5S,10S,11S,14S)-11-benzyl-5-(tert-butyl)-10-hydroxy-15,15-dimethyl-3,6,13-trioxo-8-(4-(pyridin-2-yl)benzyl)-2-oxa-4,7,8,12-tetraazahexadecan-14-yl)carbamate sulfate
methyl N-[(2S)-1-[[(2S,3S)-3-hydroxy-4-[[[(2S)-2-(methoxycarbonylamino)-3,3-dimethylbutanoyl]amino]-[(4-pyridin-2-ylphenyl)methyl]amino]-1-phenylbutan-2-yl]amino]-3,3-dimethyl-1-oxobutan-2-yl]carbamate sulfate
methyl N-[(2S)-1-[2-[(2S,3S)-2-hydroxy-3-[[(2S)-2-(methoxycarbonylamino)-3,3-dimethylbutanoyl]amino]-4-phenylbutyl]-2-[(4-pyridin-2-ylphenyl)methyl]hydrazinyl]-3,3-dimethyl-1-oxobutan-2-yl]carbamate; sulfuric acid
methyl N-[(2S)-1-[2-[(2S,3S)-2-hydroxy-3-[[(2S)-2-(methoxycarbonylamino)-3,3-dimethylbutanoyl]amino]-4-phenylbutyl]-2-[(4-pyridin-2-ylphenyl)methyl]hydrazinyl]-3,3-dimethyl-1-oxobutan-2-yl]carbamate;s
MFCD08067748
MLS003915641
MLS006010199
MolPort-016-633-312
N349
Reyataz
s1457
SCHEMBL341700
SMR002544693
ST24030092
ulfuric acid
UNII-4MT4VIE29P
Z-3316
Tentative approvals for ATAZANAVIR SULFATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up300MG/100MGTABLET; ORAL
➤ Sign Up➤ Sign Up200MGCAPSULE; ORAL
➤ Sign Up➤ Sign Up150MGCAPSULE; ORAL

US Patents and Regulatory Information for atazanavir sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol-myers Squibb EVOTAZ atazanavir sulfate; cobicistat TABLET;ORAL 206353-001 Jan 29, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bristol-myers Squibb EVOTAZ atazanavir sulfate; cobicistat TABLET;ORAL 206353-001 Jan 29, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Aurobindo Pharma Ltd ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 204806-002 Jun 25, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bristol Myers Squibb REYATAZ atazanavir sulfate POWDER;ORAL 206352-001 Jun 2, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for atazanavir sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-001 Jun 20, 2003 ➤ Sign Up ➤ Sign Up
Bristol Myers Squibb REYATAZ atazanavir sulfate POWDER;ORAL 206352-001 Jun 2, 2014 ➤ Sign Up ➤ Sign Up
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-004 Oct 16, 2006 ➤ Sign Up ➤ Sign Up
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-003 Jun 20, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for atazanavir sulfate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0030 France ➤ Sign Up PRODUCT 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
2016000120 Germany ➤ Sign Up PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCHES AKZEPTABLES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE ATAZANAVIRSULFAT; REGISTRATION NO/DATE: EU/1/15/1025 20150713
/2016 Austria ➤ Sign Up PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715
90002-8 Sweden ➤ Sign Up PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REG. NO/DATE: EU/1/15/1025 20150715
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Harvard Business School
Fuji
Cerilliant
UBS
Colorcon
Mallinckrodt
Fish and Richardson
US Department of Justice

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