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Lanreotide acetate - Generic Drug Details

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

Lanreotide acetate is the generic ingredient in one branded drug marketed by Ipsen Pharma and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Lanreotide acetate has seventy-one patent family members in seventeen countries.

There are three drug master file entries for lanreotide acetate. One supplier is listed for this compound.

Summary for lanreotide acetate

International Patents:	71
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Suppliers / Packagers:	1
Bulk Api Vendors:	27
Clinical Trials:	3
Patent Applications:	4,826
DailyMed Link:	lanreotide acetate at DailyMed

Pharmacology for lanreotide acetate

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

Synonyms for lanreotide acetate

10-(4-Aminobutyl)-19-[(2-amino-3-naphthalen-2-yl-propanoyl)amino]-N-(1 -carbamoyl-2-hydroxy-propyl)-16-[(4-hydroxyphenyl)methyl]-13-(1H-indol -3-ylmethyl)-6,9,12,15,18-pentaoxo-7-propan-2-yl-1,2-dithia-5,8,11,14, 17-pentazacy

10-(4-aminobutyl)-19-[[2-amino-3-(2-naphthyl)propanoyl]amino]-N-(1-carbamoyl-2-hydroxy-propyl)-16-[(4-hydroxyphenyl)methyl]-13-(1H-indol-3-ylmethyl)-7-isopropyl-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosan

10-(4-aminobutyl)-N-(1-amino-3-hydroxy-1-oxobutan-2-yl)-19-[(2-amino-3-naphthalen-2-ylpropanoyl)amino]-16-[(4-hydroxyphenyl)methyl]-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-7-propan-2-yl-1,2-dithia-5,8,11,14,17-pentazac

108736-35-2

127984-74-1

3-(2-Naphthalenyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide cyclic (2-->7)-disulfide acetate

33928-EP2272827A1

33928-EP2275420A1

33928-EP2295055A2

33928-EP2295416A2

33928-EP2295426A1

33928-EP2295427A1

33928-EP2298748A2

33928-EP2298764A1

33928-EP2298765A1

33928-EP2305642A2

33928-EP2311453A1

33928-EP2311808A1

33928-EP2311829A1

AC1L2FZT

AN-33681

Angiopeptin

Angiopeptin acetate

Autogel

BIM 23014

Bim-23014

C54H69N11O10S2

CHEBI:135901

CTK8G7572

D0M2YE

D0V1SB

DB06791

DC 13-116

GTPL2031

L-Threoninamide, 3-(1-naphthalenyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-, cyclic (2-7)-disulfide

L-Threoninamide, 3-(2-naphthalenyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-, cyclic (2-7)-disulfide

L000343

Lanreotida [INN-Spanish]

Lanreotide

Lanreotide [INN:BAN]

Lanreotide Autogel

Lanreotidum [INN-Latin]

LS-153748

LS-172394

Nal-cyclo(cys-tyr-trp-lys-val-cys)-thr-NH2

NCGC00181321-01

PUDHBTGHUJUUFI-UHFFFAOYSA-N

SCHEMBL14802383

SCHEMBL34091

Somatulin

Somatulin-Autogel

Somatuline

Somatuline lp (TN)

US Patents and Regulatory Information for lanreotide acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-003	Aug 30, 2007		RX	Yes	Yes
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-001	Aug 30, 2007		RX	Yes	Yes
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-002	Aug 30, 2007		RX	Yes	Yes
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-003	Aug 30, 2007		RX	Yes	Yes			Y

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Non-Orange Book US Patents for lanreotide acetate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
5,582,591	Delivery of solid drug compositions
5,616,123	Delivery of solid drug compositions
5,660,846	Methods and apparatus for the delivery of solid drug compositions
5,837,276	Apparatus for the delivery of elongate solid drug compositions

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International Patents for lanreotide acetate

Country	Document Number	Estimated Expiration
Denmark	0779805
Spain	2188669
Spain	2248206
Denmark	0778767

Supplementary Protection Certificates for lanreotide acetate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
037	Luxembourg		91037, EXPIRES: 20160511
2002 00032	Denmark