Pasireotide pamoate - Generic Drug Details

What are the generic drug sources for pasireotide pamoate and what is the scope of freedom to operate?

Pasireotide pamoate is the generic ingredient in one branded drug marketed by Recordati Rare and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pasireotide pamoate has one hundred and thirty-five patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for pasireotide pamoate

International Patents:	135
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Patent Applications:	25
DailyMed Link:	pasireotide pamoate at DailyMed

US Patents and Regulatory Information for pasireotide pamoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014		RX	Yes	No
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-005	Jun 29, 2018		RX	Yes	No
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-004	Jun 29, 2018		RX	Yes	No			Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014		RX	Yes	No			Y	Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014		RX	Yes	No			Y

Expired US Patents for pasireotide pamoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014

International Patents for pasireotide pamoate

Country	Patent Number	Title	Estimated Expiration
Argentina	066677	FORMULACION DE PASIREOTIDA. COMPOSICION FARMACEUTICA PARA LIBERACION PROLONGADA. MICROPARTICULAS.
South Africa	200907168	An extended-release composition comprising a somatostatin derivative in microparticles
Eurasian Patent Organization	018203	КОМПОЗИЦИЯ ПРОЛОНГИРОВАННОГО ВЫСВОБОЖДЕНИЯ, СОДЕРЖАЩАЯ ПАМОАТ ПАСИРЕОТИДА В МИКРОЧАСТИЦАХ С ПОЛИМЕРНОЙ МАТРИЦЕЙ, СПОСОБ ПОЛУЧЕНИЯ МИКРОЧАСТИЦ И СПОСОБ ЛЕЧЕНИЯ (AN EXTENDED-RELEASE COMPOSITION COMPRISING PASIREOTIDE PAMOAT IN MICROPARTICLES WITH A POLYMER MATRIX, PROCESS OF MAKING MICROPARTICLES AND METHOD OF TREATING)
European Patent Office	1307486	ANALOGUES DE SOMATOSTATINE (SOMATOSTATIN ANALOGUES)
Israel	175286	MICROPARTICLES COMPRISING CYCLO [{4-(NH2-C2H4-NH-CO-O)PRO}-PHG-DTRP-LYS-TYR(4-BZL)-PHE] IN FREE FORM, SALT FORM OR PROTECTED FORM EMBEDED IN A POLYMER MATRIX, PHARMACEUTICAL COMPOSITIONS COMPRISING THEM AND USE THEREOF IN THE PREPARATION OF MEDICAMENTS

Supplementary Protection Certificates for pasireotide pamoate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1307486	122012000045	Germany		PRODUCT NAME: PASIREOTID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON ODER EIN KOMPLEX HIERVON; REGISTRATION NO/DATE: EU/1/12/753/001-012 20120424
1686964	92701	Luxembourg		PRODUCT NAME: PASIREOTIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE OU UN HYDRATE QUI EN DERIVE; AUTHORISATION NUMBER AND DATE: EU/1/12/753 SIGNIFOR-PASIREOTIDE 20141121
1307486	CA 2012 00024	Denmark
1307486	SPC/GB12/030	United Kingdom		PRODUCT NAME: CYCLO((4R)-4-(2-AMINOETHYLCARBAMOYLOXY)-L-PROLYL-L-PHENYLGLYCYL-D-TRYPTOPHYL-L-LYSYL-4-O-BENZYL-L-TYROSYL-L-PHENYLALANYL-)), PASIREOTIDE, OR SALTS THEREOF; REGISTERED: UK EU/1/12/753/001-012 20120424
1686964	CR 2015 00026	Denmark		PRODUCT NAME: PASIREOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER ET HVILKET SOM HELST HYDRAT DERAF, HERUNDER PASIREOTIDDIASPARTAT; REG. NO/DATE: EU/1/12/753, C(2014)8916 20141121