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	203255-005	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	203255-005	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	Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014		RX	Yes	Yes			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	203255-003	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	203255-002	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
Cuba	24028	PROCESO PARA OBTENER MICROPARTÍCULAS MEJORADAS QUE COMPRENDEN UN DERIVADO DE SOMATOSTATINA
Cyprus	1108547
Japan	5507447
Brazil	PI0811904	COMPOSIÇÃO DE LIBERAÇÃO EXTENDIDA COMPREENDENDO UM DERIVADO DE SOMATOSTATINA EM MICROPARTÍCULAS
Montenegro	00955	KOMPOZICIJA SA PRODUŽENIM OSLOBAĐANJEM KOJA SADRŽI DERIVAT SOMATOSTATINA U MIKROČESTICAMA (AN EXTENDED-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
1686964	PA2015009	Lithuania		PRODUCT NAME: PASIREOTIDUM; REGISTRATION NO/DATE: EU/1/12/753/13 - EU/1/12/753/17 20141119
1307486	C 2012 018	Romania		PRODUCT NAME: PASIREOTIDA SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTEIACICLO[(4R)-4-(2-AMINOETILCARBAMOILOXI)-L-PROLIL-L-FENILGLICIL-D-TRIPTOFIL-L-LISIL-4-O-BENZIL-L-TIROSIL-L-FENILALANIL-); NATIONAL AUTHORISATION NUMBER: RO EU/1/12/753/001 - RO EU/1/12/753/012; DATE OF NATIONAL AUTHORISATION: 20120424; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/753/001 - EMEA EU/1/12/753/012; DATE OF FIRST AUTHORISATION IN EEA: 20120424
1686964	C01686964/01	Switzerland		PRODUCT NAME: PASIREOTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65148 25.02.2015
1686964	C 2015 008	Romania		PRODUCT NAME: PASIREOTIDA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIASAU ORICE HIDRAT AL ACESTEIACICLO[(4R)-4-(2-AMINOETILCARBAMOILOXI)-L-PROLIL-L-FENILGLICIL-D-TRIPTOFIL-L-LISIL-4-O-BENZIL-L-TIROSIL-L-FENILALANIL-); NATIONAL AUTHORISATION NUMBER: EU/1/12/753/013, EU/1/12/753/014, EU/1/12/753/015, EU/1/12/753/016, EU/1/12/753/017; DATE OF NATIONAL AUTHORISATION: 20141119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/753/013, EU/1/12/753/014, EU/1/12/753/015, EU/1/12/753/016, EU/1/12/753/017; DATE OF FIRST AUTHORISATION IN EEA: 20141119
1307486	1290022-1	Sweden		PRODUCT NAME: PASIREOTID; REG. NO/DATE: EU/1/12/753/001 20120424