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Didanosine - Generic Drug Details

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

Didanosine is the generic ingredient in three branded drugs marketed by Aurobindo Pharma, Barr, Mylan Pharms Inc, Bristol Myers Squibb, Bristol-myers Squibb, and Aurobindo, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for didanosine. Five suppliers are listed for this compound.

Summary for didanosine

US Patents:	0
Tradenames:	3
Applicants:	6
NDAs:	9
Drug Master File Entries:	8
Suppliers / Packagers:	5
Bulk Api Vendors:	98
Clinical Trials:	144
Patent Applications:	6,487
Formulation / Manufacturing:	see details
DailyMed Link:	didanosine at DailyMed

Pharmacology for didanosine

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

Medical Subject Heading (MeSH) Categories for didanosine

Anti-HIV Agents

Antimetabolites

Reverse Transcriptase Inhibitors

Synonyms for didanosine

2 inverted exclamation mark ,3 inverted exclamation mark -Dideoxyinosine

2,3-dideoxyinosine

2', 3'-dideoxyinosine

2',3'-Dideoxyinosine

2',3'-Dideoxyinosine (AIDS Initiative)

2',3'-Dideoxyinosine (ddI)

2',3'-Dideoxyinosine & Granulocyte-macrophage colony-stimulating factor

2',3'-Dideoxyinosine & Interferon-.alpha.

2',3'-Dideoxyinosine & Interferon-alpha

2',3'-Dideoxyinosine & sCD4(soluble recombinant protein)

2',3'-Dideoxyinosine, >=98% (HPLC)

2',3'-dideoxyinosine, DDI, NSC 612049, Didanosine

2',3'-didesoxyinosin

2'3'-DIDEOXYINOSINE

2DI

3'-Azido-3'-deoxythymidine + 2',3'-Dideoxyinosine

3'-dideoxyinosine

655D056

69655-05-6

9-((2R,5S)-5-(hydroxymethyl)-tetrahydrofuran-2-yl)-1H-purin-6(9H)-one

9-((2R,5S)-5-(hydroxymethyl)tetrahydrofuran-2-yl)-3,9-dihydro-6H-purin-6-one

9-((2R,5S)-5-(hydroxymethyl)tetrahydrofuran-2-yl)-9H-purin-6-ol

9-((2R,5S)-5-Hydroxymethyl-tetrahydro-furan-2-yl)-1,9-dihydro-purin-6-one

9-((2S,5R)-5-Hydroxymethyl-tetrahydro-furan-2-yl)-9H-purin-6-ol

9-(2,3-Dideoxy-beta-D-ribofuranosyl)-6-oxopurine

9-(2,3-Dideoxy-beta-D-ribofuranosyl)hypoxanthine

9-[(2R,5R)-5-(HYDROXYMETHYL)TETRAHYDROFURAN-2-YL]-1,9-DIHYDRO-6H-PURIN-6-ONE

9-[(2R,5S)-5-(hydroxymethyl)oxolan-2-yl]-1H-purin-6-one

9-[(2R,5S)-5-(hydroxymethyl)oxolan-2-yl]-3H-purin-6-one

9-[(2R,5S)-5-(HYDROXYMETHYL)OXOLAN-2-YL]-6,9-DIHYDRO-1H-PURIN-6-ONE

9-[(2R,5S)-5-(HYDROXYMETHYL)OXOLAN-2-YL]-6,9-DIHYDRO-3H-PURIN-6-ONE

9-[(2R,5S)-5-(hydroxymethyl)tetrahydrofuran-2-yl]-1,9-dihydro-6H-purin-6-one

9-[(2R,5S)-5-(hydroxymethyl)tetrahydrofuran-2-yl]-1H-purin-6-one

9-[(2R,5S)-5-(hydroxymethyl)tetrahydrofuran-2-yl]-3H-purin-6-one

AB0014064

AB0069772

AB2000230

AC-12026

AC1L19ET

AJ-64234

AK-87600

AKOS015833088

AKOS015901454

AKOS015963259

AKOS026750545

AN-37869

ANW-35738

BC203896

BDBM50404252

Bio-0685

BMY 40900

BMY-40900

BRN 3619529

BXZVVICBKDXVGW-NKWVEPMBSA-N

C06953

CAS-69655-05-6

CCG-100947

CCG-220153

CCRIS 805

CHEBI:490877

CHEMBL1460

CJ-14439

CPD000058576

CS-2229

D00296

D06FDR

D0P6OM

D2I

D3066

DB-055315

DB00900

DDI

ddI & GM-CSF

ddI & IFN-.alpha.

DdI & IFN-alpha

ddI & sCD4(rsCD4)

ddI + d4T combination

DDI and rIFN.alpha.2

ddIno

Didanosina

Didanosina [INN-Spanish]

Didanosine (JAN/USAN/INN)

Didanosine (Videx)

Didanosine [USAN:USP:INN:BAN]

Didanosine and Interferon-.alpha.-2

Didanosine for system suitability, European Pharmacopoeia (EP) Reference Standard

Didanosine, European Pharmacopoeia (EP) Reference Standard

Didanosine, United States Pharmacopeia (USP) Reference Standard

Didanosinum

Didanosinum [INN-Latin]

DIDEOXYINOSINE

Dideoxyinosine (DDI)

DRG-0016

DS-4152 & ddI

DSSTox_CID_2927

DSSTox_GSID_22927

DSSTox_RID_76791

DTXSID6022927

FT-0082664

GTPL4833

HE301567

HMS2051J11

HMS2089N20

HMS2095O08

HMS2232P22

HSDB 6548

HY-B0249

Hypoxanthine ddN

INO001

Inosine, 2',3'-dideoxy-

Inosine, 2',3'-dideoxy- & Recombinant Interferon-.alpha.-2

Inosine, 2',3'-dideoxy-& Recombinant Interferon-.alpha.-2

Intron A & Videx

J-700356

J10315

K166

K3GDH6OH08

KS-00000FVB

KS-1049

Lecithinized superoxide dismutase & Inosine, 2',3'-dideoxy-

Listera ovata agglutinin & 2',3'-Dideoxyinosine

LOA & ddI

MCULE-2844514954

MFCD00077728

MLS000759469

MLS001055350

MLS001424118

MLS002154216

MLS006011561

MolPort-002-507-371

MolPort-003-846-628

MolPort-006-167-656

NC00197

NCGC00090691-01

NCGC00090691-02

NCGC00090691-03

NCGC00159514-02

NCGC00159514-03

NCGC00159514-04

NCGC00164280-01

NCGC00188983-01

NCGC00254496-01

NCGC00259882-01

NSC 612049

NSC612049

NU000191

NU005155

PC-SOD+ddI

RTR-030612

S1702

SAM001246673

SC-58339

SCHEMBL3363

SMR000058576

SMR004703324

SRI-7013_07

SRI-7013-04

SRI-7013-05

Sulfated polysaccharide-peptidoglycan DS-4152 & 2',3'-Dideoxyinosine

Tox21_111732

Tox21_111732_1

Tox21_202333

Tox21_300575

TR-030612

UNII-K3GDH6OH08

Videx

Videx (TN)

Videx EC

Videx EC (TN)

Videx EC;Videx

Videx EC(TM)(slow-release capsules)

Videx(TM)

W-203551

Z1692482604

ZINC13597823

US Patents and Regulatory Information for didanosine

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	VIDEX	didanosine	FOR SOLUTION;ORAL	020155-003	Oct 9, 1991		DISCN	No	No
Bristol Myers Squibb	VIDEX	didanosine	FOR SOLUTION;ORAL	020155-006	Oct 9, 1991		DISCN	No	No
Mylan Pharms Inc	DIDANOSINE	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	090788-002	Apr 8, 2010		DISCN	No	No
Aurobindo Pharma	DIDANOSINE	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	090094-004	Sep 24, 2008	AB	RX	No	No

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Expired US Patents for didanosine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	VIDEX	didanosine	FOR SOLUTION;ORAL	020155-004	Oct 9, 1991
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-005	Oct 9, 1991
Bristol Myers Squibb	VIDEX	didanosine	FOR SOLUTION;ORAL	020155-006	Oct 9, 1991
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-003	Oct 9, 1991

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