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Generated: September 24, 2019

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Stavudine - Generic Drug Details

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

Stavudine is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Aurobindo Pharma, Hetero Labs Ltd Iii, Mylan, Mylan Labs Ltd, Cipla Ltd, and Bristol-myers Squibb, and is included in nine NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Stavudine has twenty-eight patent family members in twenty-five countries.

There are fourteen drug master file entries for stavudine. Five suppliers are listed for this compound. There are ten tentative approvals for this compound.

Medical Subject Heading (MeSH) Categories for stavudine
Synonyms for stavudine
056S175
1-((2R,5S)-5-(hydroxymethyl)-2,5-dihydrofuran-2-yl)-5-methylpyrimidine-2,4(1H,3H)-dione
1-((2R,5S)-5-Hydroxymethyl-2,5-dihydro-furan-2-yl)-5-methyl-1H-pyrimidine-2,4-dione
1-(2,3-Dideoxy-.beta.-D-glycero-pent-2-enofuranosyl)thymine
1-(2,3-Dideoxy-beta-D-glycero-2-pentenofuranosyl)thymine
1-(2,3-Dideoxy-beta-D-glycero-pent-2-enofuranosyl)thymine
1-(5-Hydroxymethyl-2,5-dihydro-furan-2-yl)-5-methyl-1H-pyrimidine-2,4-dione
1-(5-Hydroxymethyl-2,5-dihydro-furan-2-yl)-5-methyl-1H-pyrimidine-2,4-dione (ddeThd)
1-[(2R,5S)-2,5-Dihydro-5-(hydroxymethyl)-2-furanyl]-5-methyl-2,4(1H,3H)-pyrimidinedione
1-[(2R,5S)-5-(HYDROXYMETHYL)-2,5-DIHYDROFURAN-2-YL]-5-METHYL-1,2,3,4-TETRAHYDROPYRIMIDINE-2,4-DIONE
1-[(2R,5S)-5-(hydroxymethyl)-2,5-dihydrofuran-2-yl]-5-methyl-pyrimidine-2,4-dione
1-[(2R,5S)-5-(Hydroxymethyl)-2,5-dihydrofuran-2-yl]-5-methylpyrimidine-2,4-(1H,3H)-dione
1-[(2R,5S)-5-(hydroxymethyl)-2,5-dihydrofuran-2-yl]-5-methylpyrimidine-2,4-dione
1-[(2R,5S)-5-(hydroxymethyl)-2,5-dihydrofuran-2-yl]-5-methylpyrimidine-2,4(1H,3H)-dione
1-[5-(hydroxymethyl)-2,5-dihydro-2-furanyl]-5-methyl-2,4(1H,3H)-pyrimidinedione & Colony-stimulating factor 2
132425-31-1
2'-Thymidinene, 3'-deoxy-
2',3'-Anhydrothymidine
2',3'-Anhydrothymidine; d4T
2',3'-didehydro-2',3'-dideoxythymidine
2',3'-Didehydro-3'-deoxy-thymidine
2',3'-Didehydro-3'-deoxythimidine
2',3'-Didehydro-3'-deoxythymidine
2',3'-DIDEHYDRO-3'-DEOXYTHYMIDINE (DDI)
2',3'-Didehydro-3'-deoxythymidine, >=98% (TLC)
2'',3''-didehydro-3''-deoxythymidine
2'',3''-dideoxy-2'',3''-didehydrothymidine
3'- Azido-3'-deoxythymidine & Granulocyte-macrophage colony-stimulating factor
3'-Deoxy-2'-thymidinene
3'-Deoxy-2',3'-didehydro-D-thymidine
3'-Deoxy-2',3'-didehydrothymidine
3'-Deoxy-2',3'-didehydrothymidine, 98%
3'-deoxythymidin-2'-ene
3''-deoxy-2''-thymidine
3''-deoxy-2'',3''-didehydrothymidine
3056-17-5
A820433
AB0013374
AB00383018_18
AB1009564
ABP000995
AC-5263
AC1L2BQ9
AC1Q6BSH
AJ-12338
AK-77340
AKOS005622554
AN-7246
ANW-26914
BBL033763
BC203877
BCP02952
BDBM50013111
BIDD:GT0082
BMY 27857
BMY-27857
BO9LE4QFZF
BR-77340
BRN 0618327
C07312
CAS-3056-17-5
CCG-100902
CHEBI:63581
CHEMBL991
cid_18283
cid_5155
CPD000058350
CPD000673569
CS-1872
CTK8B1419
D 1413
D 4T
D 4T (nucleoside)
D00445
D3580
d4T
D4T & GM-CSF
D4TMBY-27857-3
DB00649
ddeThd
ddeTyd
Dideoxydidehydrothymidine
DSSTox_CID_3819
DSSTox_GSID_23819
DSSTox_RID_77198
DTXSID1023819
Estavudina
Estavudina [INN-Spanish]
EU-0100336
FT-0082665
FT-0603625
H940
HMS2051O20
HMS2234C10
HMS3039O05
HMS3259L21
HMS3261C13
HMS3428C07
HMS3714N22
HSDB 7338
HY-B0116
J-700246
J10003
KS-00000H34
KS-1115
Lopac0_000336
LP00336
LS-1160
MCULE-9252477726
MFCD00132921
MLS000028546
MLS000759504
MLS001055348
MLS001077292
MLS001424091
MLS006011922
MolPort-002-507-283
NC00152
NC00684
NCGC00023212-03
NCGC00023212-04
NCGC00023212-05
NCGC00023212-07
NCGC00023212-08
NCGC00023212-09
NCGC00023212-10
NCGC00023212-11
NCGC00023212-12
NCGC00023212-13
NCGC00023212-14
NCGC00254372-01
NCGC00258944-01
NCGC00261021-01
NSC 163661
NSC-759897
NSC163661
NSC759897
Opera_ID_1281
Pharmakon1600-01502339
PubChem5805
Q-201742
RP07238
S-2155
SAM001246729
SAM002589948
sanilvudine
Sanilvudine (JAN)
SC-03292
SCHEMBL38661
SMR000058350
SMR000673569
SR-01000075802
SR-01000075802-1
SR-01000075802-4
Stavudin
Stavudine (USAN/INN)
Stavudine [USAN:BAN:INN]
Stavudine [USAN:INN:BAN]
Stavudine [USAN:USP:INN:BAN]
Stavudine for system suitability, European Pharmacopoeia (EP) Reference Standard
Stavudine, European Pharmacopoeia (EP) Reference Standard
Stavudine, United States Pharmacopeia (USP) Reference Standard
Stavudinum
Stavudinum [INN-Latin]
STK801888
STV
Thymidine, 2',3'-didehydro-, 3'-deoxy-
Thymidine, 2',3'-didehydro-3'-deoxy-
Thymine, 1-(2,3-dideoxy-beta-D-glycero-pent-2-enofuranosyl)- (7CI,8CI)
Tox21_110886
Tox21_110886_1
Tox21_201393
Tox21_300583
Tox21_500336
UNII-BO9LE4QFZF
XNKLLVCARDGLGL-JGVFFNPUSA-N
Z1695906749
ZB004848
Zent
Zerit
Zerit (TN)
Zerit Xr
Zerit(TM)
Zerut XR
ZINC137884
Generic filers with tentative approvals for STAVUDINE
Applicant Application No. Strength Dosage Form
  Try a Free Trial  Try a Free Trial40MG; 150MG; 200MGTABLET; ORAL
  Try a Free Trial  Try a Free Trial40MG; 150MGTABLET; ORAL
  Try a Free Trial  Try a Free Trial40MG; 150MG; 200MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for stavudine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd Iii STAVUDINE stavudine CAPSULE;ORAL 078957-002 Dec 29, 2008 AB RX No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Aurobindo Pharma STAVUDINE stavudine CAPSULE;ORAL 077672-002 Dec 29, 2008 AB RX No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Mylan Labs Ltd STAVUDINE stavudine CAPSULE;ORAL 078775-002 Jan 5, 2009 DISCN No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for stavudine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-001 Dec 31, 2002   Try a Free Trial   Try a Free Trial
Bristol Myers Squibb ZERIT stavudine CAPSULE;ORAL 020412-004 Jun 24, 1994   Try a Free Trial   Try a Free Trial
Bristol Myers Squibb ZERIT stavudine CAPSULE;ORAL 020412-005 Jun 24, 1994   Try a Free Trial   Try a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for stavudine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0273277 SPC/GB96/049 United Kingdom   Try a Free Trial PRODUCT NAME: STAVUDINE; REGISTERED: UK EU/1/96/009/001 19960508; UK EU/1/96/009/002 19960508; UK EU/1/96/009/003 19960508; UK EU/1/96/009/004 19960508; UK EU/1/96/009/005 19960508; UK EU/1/96/009/006 19960508; UK EU/1/96/009/007 19960508; UK EU/1/96/009/008 19960508; UK EU/1/96/009/009 19960508
0273277 96C0039 Belgium   Try a Free Trial PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 19960508
0273277 C960024 Netherlands   Try a Free Trial PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 - EU/1/96/009/009 19960508
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Accenture
Cantor Fitzgerald
Johnson and Johnson
Medtronic
Queensland Health

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