PASIREOTIDE PAMOATE - Generic Drug Details

What are the generic drug sources for pasireotide pamoate and what is the scope of patent protection?

Pasireotide pamoate is the generic ingredient in one branded drug marketed by Recordati Rare and is included in one NDA. There are three 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:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Patent Applications:	15
DailyMed Link:	PASIREOTIDE PAMOATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PASIREOTIDE PAMOATE

Dosage:

FOR SUSPENSION;INTRAMUSCULAR

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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	203255-004	Jun 29, 2018		RX	Yes	No			Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014		RX	Yes	No			Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014		RX	Yes	No			Y
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
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014		RX	Yes	No

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	203255-002	Dec 15, 2014
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	203255-001	Dec 15, 2014
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	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
Australia	2001289778
Brazil	0112859
Taiwan	I282341
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)
Norway	337172
Tunisia	2009000447	AN EXTENTED-RELEASE COMPOSITION COMPRISING A SOMATOSTATIN DERIVATIVE IN MICROPARTICLES

Supplementary Protection Certificates for PASIREOTIDE PAMOATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1307486	CA 2012 00024	Denmark
1307486	1290022-1	Sweden		PRODUCT NAME: PASIREOTID; REG. NO/DATE: EU/1/12/753/001 20120424
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	122015000015	Germany		PRODUCT NAME: PASIREOTID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER JEGLICHES HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/12/753/013-017 20141119
1307486	132012902062571	Italy		PRODUCT NAME: PASIREOTIDE DIASPARTATO(SIGNIFOR); AUTHORISATION NUMBER(S) AND DATE(S): EU71/12/753/001-012, 20120424
1307486	12C0041	France		PRODUCT NAME: CYCLO((4R)-4(2-AMINOETHYLCARBAMOYLOXY)-L-PROLYL-L-PHENYLGLYCYL-D-TRYPTOPHYL-L-LYSYL-4-O-BENZYL-L-TYROSYL-L-PHENYLALANYL-) : PASIREOTIDE, OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/12/753/001 20120424