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Octreotide acetate - Generic Drug Details

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, Usv North America, West-ward Pharms Int, Wockhardt Usa, Mylan Institutional, and Novartis, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for octreotide acetate. Ten suppliers are listed for this compound.

Summary for octreotide acetate

US Patents:	0
Tradenames:	5
Applicants:	9
NDAs:	19
Drug Master File Entries:	20
Suppliers / Packagers:	10
Bulk Api Vendors:	94
Clinical Trials:	29
Patent Applications:	26
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for octreotide acetate
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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
West-ward Pharms Int	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	076330-001	Apr 8, 2005	AP	RX	No	Yes	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
West-ward Pharms Int	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	octreotide acetate	INJECTABLE;INJECTION	076313-001	Mar 28, 2005	AP	RX	No	Yes	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Fresenius Kabi Usa	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	octreotide acetate	INJECTABLE;INJECTION	077457-001	Feb 10, 2006	AP	RX	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-002	Oct 21, 1988	AP	RX	Yes	Yes	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Sun Pharm Inds	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	077331-001	Mar 4, 2008		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 octreotide acetate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-002	Oct 21, 1988	➤ Try a Free Trial	➤ Try a Free Trial
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-005	Jun 12, 1991	➤ Try a Free Trial	➤ Try a Free Trial
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-001	Nov 25, 1998	➤ Try a Free Trial	➤ Try a Free Trial
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-001	Oct 21, 1988	➤ Try a Free Trial	➤ Try a Free Trial
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration