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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.

Summary for stavudine

International Patents:	28
US Patents:	1
Tradenames:	3
Applicants:	7
NDAs:	9
Drug Master File Entries:	14
Suppliers / Packagers:	5
Bulk Api Vendors:	105
Clinical Trials:	153
Patent Applications:	5,886
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for stavudine
DailyMed Link:	stavudine at DailyMed

Pharmacology for stavudine

Drug Class	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for stavudine

Anti-HIV Agents

Antimetabolites

Reverse Transcriptase Inhibitors

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
		40MG; 150MG; 200MG	TABLET; ORAL
		40MG; 150MG	TABLET; ORAL
		40MG; 150MG; 200MG	TABLET; 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
Aurobindo Pharma	STAVUDINE	stavudine	CAPSULE;ORAL	077672-002	Dec 29, 2008	AB	RX	No	No
Mylan Labs Ltd	STAVUDINE	stavudine	CAPSULE;ORAL	078775-002	Jan 5, 2009		DISCN	No	No

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
Bristol Myers Squibb	ZERIT	stavudine	CAPSULE;ORAL	020412-004	Jun 24, 1994
Bristol Myers Squibb	ZERIT	stavudine	CAPSULE;ORAL	020412-005	Jun 24, 1994

International Patents for stavudine

Country	Patent Number	Estimated Expiration
European Patent Office	1267879
Czech Republic	20023003
Latvia	12939

Supplementary Protection Certificates for stavudine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0273277	SPC/GB96/049	United Kingdom		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		PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 19960508
0273277	C960024	Netherlands		PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 - EU/1/96/009/009 19960508