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Octreotide acetate - Generic Drug Details

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

Octreotide acetate is the generic ingredient in five branded drugs marketed by Fresenius Kabi Usa, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, West-ward Pharms Int, Wockhardt Usa, Mylan Institutional, and Novartis, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for octreotide acetate. Nine suppliers are listed for this compound.

Summary for octreotide acetate

US Patents:	0
Tradenames:	5
Applicants:	8
NDAs:	18
Drug Master File Entries:	19
Suppliers / Packagers:	9
Bulk Api Vendors:	92
Clinical Trials:	28
Patent Applications:	2,694
Formulation / Manufacturing:	see details
DailyMed Link:	octreotide acetate at DailyMed

Pharmacology for octreotide acetate

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

Medical Subject Heading (MeSH) Categories for octreotide acetate

Antineoplastic Agents, Hormonal

Gastrointestinal Agents

Synonyms for octreotide acetate

(4R,7S,10S,13R,16S,19R)-10-(4-aminobutyl)-19-[[(2R)-2-amino-1-oxo-3-phenylpropyl]amino]-N-[(2R,3R)-1,3-dihydroxybutan-2-yl]-7-[(1R)-1-hydroxyethyl]-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-16-(phenylmethyl)-1,2-dithia-5

(4R,7S,10S,13R,16S,19R)-10-(4-aminobutyl)-19-[[(2R)-2-amino-3-phenyl-propanoyl]amino]-16-benzyl-7-[(1R)-1-hydroxyethyl]-N-[(1R,2R)-2-hydroxy-1-(hydroxymethyl)propyl]-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5

(4R,7S,10S,13R,16S,19R)-10-(4-aminobutyl)-19-[[(2R)-2-amino-3-phenylpropanoyl]amino]-16-benzyl-N-[(2R,3R)-1,3-dihydroxybutan-2-yl]-7-[(1R)-1-hydroxyethyl]-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17

(4R,7S,10S,13R,16S,19R)-10-(4-azanylbutyl)-19-[[(2R)-2-azanyl-3-phenyl-propanoyl]amino]-N-[(2R,3R)-1,3-bis(oxidanyl)butan-2-yl]-13-(1H-indol-3-ylmethyl)-7-[(1R)-1-oxidanylethyl]-6,9,12,15,18-pentakis(oxidanylidene)-16-(phenyl

(4R,7S,10S,13R,16S,19R)-13-((1H-indol-3-yl)methyl)-19-((R)-2-amino-3-phenylpropanamido)-10-(4-aminobutyl)-16-benzyl-N-((2R,3R)-1,3-dihydroxybutan-2-yl)-7-((R)-1-hydroxyethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pent

(4R,7S,10S,13R,16S,19R)-13-((1H-indol-3-yl)methyl)-19-((R)-2-amino-3-phenylpropanamido)-10-(4-aminobutyl)-16-benzyl-N-(1,3-dihydroxybutan-2-yl)-7-((R)-1-hydroxyethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycl

10-(4-Amino-butyl)-19-(2-amino-3-phenyl-propionylamino)-16-benzyl-7-(1-hydroxy-ethyl)-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaaza-cycloicosane-4-carboxylic acid (2-hydroxy-1-

10-(4-Amino-butyl)-19-(2-amino-3-phenyl-propionylamino)-16-benzyl-7-(1-hydroxy-ethyl)-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaaza-cycloicosane-4-carboxylic acid (2-hydroxy-1-hydroxymethyl-p

10-(4-aminobutyl)-16-benzyl-N-(1,3-dihydroxybutan-2-yl)-7-(1-hydroxyethyl)-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-19-(phenylalanylamino)-1,2-dithia-5,8,11,14,17-pentaazacycloicosane-4-carboxam

10-(4-Aminobutyl)-19-((2-amino-3-phenylpropanoyl)amino)-16-benzyl-7-(1-hydroxyethyl)-N-(2-hydroxy-1-(hydroxymethyl)propyl)-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaa

10-(4-Aminobutyl)-19-((2-amino-3-phenylpropanoyl)amino)-16-benzyl-7-(1-hydroxyethyl)-N-(2-hydroxy-1-(hydroxymethyl)propyl)-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosane-4-carboxam

10-(4-aminobutyl)-19-[(2-amino-3-phenyl-propanoyl)amino]-16-benzyl-7-(1-hydroxyethyl)-N-[2-hydroxy-1-(hydroxymethyl)propyl]-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carboxam

10-(4-aminobutyl)-19-[(2-amino-3-phenylpropanoyl)amino]-16-benzyl-N-(1,3-dihydroxybutan-2-yl)-7-(1-hydroxyethyl)-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carboxamide

10-(4-aminobutyl)-19-[(2-amino-3-phenylpropanoyl)amino]-16-benzyl-N-[(2R,3R)-1,3-dihydroxybutan-2-yl]-7-(1-hydroxyethyl)-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carboxamide

10-(4-aminobutyl)-19-[(2-amino-3-phenylpropanoyl)amino]-N-(1,3-dihydroxybutan-2-yl)-7-(1-hydroxyethyl)-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-16-(phenylmethyl)-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carboxamide

13-((1H-indol-3-yl)methyl)-19-(2-amino-3-phenylpropanamido)-10-(4-aminobutyl)-16-benzyl-N-(1,3-dihydroxybutan-2-yl)-7-(1-hydroxyethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-

17O014

19-(2-amino-3-phenylpropanamido)-10-(4-aminobutyl)-16-benzyl-N-[(2R,3R)-1,3-dihydroxybutan-2-yl]-7-(1-hydroxyethyl)-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosane-4-carboxamide; bi

2-{[(13R,16S,19R)-10-(4-Amino-butyl)-19-((S)-2-amino-3-phenyl-propionylamino)-16-benzyl-7-(1-hydroxy-ethyl)-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaaza-cycloicosane-4-carbonyl]-amino}-3-hyd

3944AH

517O014

75R0U2568I

79517-01-4

79517-01-4 (acetate salt)

79517-01-4b

83150-76-9

83150-76-9 (Parent)

A840511

AB0091082

AB01275486-01

AC-28733

AC-663

AC1L1GVR

AC1L8LCA

AC1L8LCD

AC1L9AUI

AC1L9M4X

AC1OCEUW

AC1Q2BPN

acetic acid; (4R,7S,10S,13R,16S,19R)-10-(4-aminobutyl)-19-[[(2R)-2-amino-3-phenylpropanoyl]amino]-16-benzyl-N-[(2R,3R)-1,3-dihydroxybutan-2-yl]-7-[(1R)-1-hydroxyethyl]-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia

acetic acid; 10-(4-aminobutyl)-19-[(2-amino-3-phenyl-propanoyl)amino]-16-benzyl-7-(1-hydroxyethyl)-N-[(1R,2R)-2-hydroxy-1-(hydroxymethyl)propyl]-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacy

acetic acid; 10-(4-aminobutyl)-19-[(2-amino-3-phenylpropanoyl)amino]-16-benzyl-N-(1,3-dihydroxybutan-2-yl)-7-(1-hydroxyethyl)-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carbox

acetic acid; 10-(4-aminobutyl)-19-[(2-amino-3-phenylpropanoyl)amino]-16-benzyl-N-[(2R,3R)-1,3-dihydroxybutan-2-yl]-7-(1-hydroxyethyl)-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-

acetic acid; 10-(4-aminobutyl)-19-[(2-amino-3-phenylpropanoyl)amino]-N-[(2R,3R)-1,3-dihydroxybutan-2-yl]-7-(1-hydroxyethyl)-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-16-(phenylmethyl)-1,2-dithia-5,8,11,14,17-pentazacyclo

AKOS015994656

AKOS025402226

AKOS026750549

AKOS030485976

AM033020

AM034456

AN-15653

AN-36562

BC220531

BDBM50272772

C07306

C2L

C49H66N10O10S2.C2H4O2

C5H12O2.C4H10

CCRIS 8708

CHEMBL1200480

CHEMBL1680

CHEMBL2000504

CHEMBL262746

CO-022

CS-0944

CS-7590

D-Phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L- threonyl-N-((1R,2R)-2-hydroxy-1-(hydroxymethyl)propyl)-L- cysteinamide cyclic (2->7)-disulfide

D-Phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-L-cysteinyl-L-threoninol cyclic (2-7)-disulfide

D-Phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-((1R,2R)-2-hydroxy-1-(hydroxymethyl)propyl)-L-cysteinamide cyclic (2->7)-disulfide

D-Phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-((1R,2R)-2-hydroxy-1-(hydroxymethyl)propyl)-L-cysteinamide cyclic (2->7)-disulfide acetate (salt)

D-Phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-((1R,2R)-2-hydroxy-1-(hydroxymethyl)propyl)-L-cysteinamide cyclic (2-7)-disulfide

D-Phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-((1R,2R)-2-hydroxy-1-(hydroxymethyl)propyl)-L-cysteinamide cyclic (2-7)-disulfide acetate (salt)

D-Phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[(1R,2R)-2-hydroxy-1-(hydroxymethyl)propyl]-L-cysteinamide Cyclic (2-7)-Disulfide Acetate

D-Phenylalanyl-L-hemicystyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-L-hemicystyl-L-threoninol cyclic (2->7)-disulfide acetate (salt)

D-Phenylalanyl-L-hemicystyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-L-hemicystyl-L-threoninol cyclic (2-7)-disulfide acetate (salt)

D-phenylalanyl-L-hemicystyl-L-phenylalanyl-D-trytophyl-L-lysyl-L-threonyl-L-hemicystyl-L-threoninol, acetate

D00442

D00TIG

D02250

D02XIY

D06495

DARAMONOL

DB00104

DEQANNDTNATYII-OULOTJBUSA-N

DR003664

DR003690

DRG-0115

FT-0630867

FT-0630918

GTPL2055

H-D-Phe-Cys-Phe-D-Trp-Lys-Thr-Cys-L-threoninol disulfide bond acetate salt

HMS2090C09

HS-2020

HY-17365

HY-P0036

KS-000011F3

L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L- threonyl-N-(2-hydroxy-1-(hydroxymethyl)propyl)-, cyclic (2->7)-disulfide, (R-(R*,R*))-

L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-(2-hydroxy-1-(hydroxymethyl)propyl)-, cyclic (2->7)-disulfide

L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-(2-hydroxy-1-(hydroxymethyl)propyl)-, cyclic (2-7)-disulfide, (R-(R*,R*))-

L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-(2-hydroxy-1-(hydroxymethyl)propyl)-, cyclic (2-7)-disulfide, (R-(R*,R*))-, acetate (salt)

L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-(2-hydroxy-1-(hydroxymethyl)propyl)-, cyclic(2-7)-disulfide, (R-(R*,R*))-, acetate (salt)

L000453

Longastatin

Longastatina

Longastatina LAR

LS-177735

LS-187135

LS-58978

MFCD00871400

MFCD08277638

MolPort-006-069-387

MolPort-009-194-181

NCI60_025753

NSC-671663

NSC-672461

NSC-685403

NSC671663

NSC672461

Octeotride SDI

Octreolin

Octreotida

Octreotida [Spanish]

Octreotide

Octreotide (acetate)

Octreotide (USAN/INN)

Octreotide [USAN:INN:BAN]

Octreotide acetate (JAN)

Octreotide acetate (preservative free)

Octreotide acetate (USAN)

Octreotide acetate [USAN:JAN]

Octreotide Acetate Depot

Octreotide Acetate Salt

Octreotide diacetate

Octreotide LAR

Octreotide-LAR

Octreotide, >=98% (HPLC)

Octreotideacetate

Octreotidum

Octreotidum [Latin]

Octrotide

pentaazacycloicosane-4-carboxamide

Q-201501

RG3806

RWM8CCW8GP

SAN 201-995

Sandostatin

Sandostatin (TN)

Sandostatin LAR

Sandostatin LAR Depot

Sandostatine

Sandoz 201-995

SCHEMBL10044649

SCHEMBL15926145

SCHEMBL58453

SCHEMBL678434

SM 201-995

SMS 201-995

SMS 201-995 AC

SMS 201-995ac

SMS 201,995

SMS-201-995

SMS-201-995 AC

SMS-201995

SMS-995

STL483734

UNII-75R0U2568I

UNII-RWM8CCW8GP

VAP-003

VP-003

XQEJFZYLWPSJOV-XJQYZYIXSA-N

zacycloicosane-4-carboxamide acetate

US Patents and Regulatory Information for octreotide acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wockhardt Usa	OCTREOTIDE ACETATE PRESERVATIVE FREE	octreotide acetate	INJECTABLE;INJECTION	090985-002	May 11, 2011		DISCN	No	No
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-003	Oct 21, 1988	AP	RX	Yes	Yes
West-ward Pharms Int	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	octreotide acetate	INJECTABLE;INJECTION	076313-002	Mar 28, 2005	AP	RX	No	Yes
Teva Pharms Usa	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	075957-001	Oct 3, 2005	AP	RX	No	No

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Expired US Patents for octreotide acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-001	Nov 25, 1998
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-004	Jun 12, 1991
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-001	Oct 21, 1988

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