SIGNIFOR LAR KIT Drug Patent Profile

Which patents cover Signifor Lar Kit, and what generic alternatives are available?

Signifor Lar Kit is a drug marketed by Recordati Rare and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and thirty-five patent family members in fifty-three countries.

The generic ingredient in SIGNIFOR LAR KIT is pasireotide pamoate. One supplier is listed for this compound. Additional details are available on the pasireotide pamoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Signifor Lar Kit

Signifor Lar Kit was eligible for patent challenges on December 14, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 23, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SIGNIFOR LAR KIT

International Patents:	135
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	7
DailyMed Link:	SIGNIFOR LAR KIT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SIGNIFOR LAR KIT

NDA:

203255

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.

Recent Clinical Trials for SIGNIFOR LAR KIT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Colorado, Denver	Phase 1
Hospices Civils de Lyon	Phase 2
Zealand University Hospital	Phase 4

See all SIGNIFOR LAR KIT clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for SIGNIFOR LAR KIT

H01CB	Somatostatin and analogues
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for SIGNIFOR LAR KIT

SIGNIFOR LAR KIT is protected by four US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SIGNIFOR LAR KIT

FDA Regulatory Exclusivity protecting SIGNIFOR LAR KIT

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	Y
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	203255-001	Dec 15, 2014		RX	Yes	No			Y	Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-004	Jun 29, 2018		RX	Yes	No
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-005	Jun 29, 2018		RX	Yes	No			Y

Expired US Patents for SIGNIFOR LAR KIT

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	203255-003	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

International Patents for SIGNIFOR LAR KIT

See the table below for patents covering SIGNIFOR LAR KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	2012012
Slovakia	177097	SOMATOSTATIN PEPTIDES
Norway	317867
Cuba	20090200	UNA COMPOSICIÓN DE LIBERACIÓN PROLONGADA QUE COMPRENDE UN DERIVADO DE SOMATOSTATINA EN MICROPARTÍCULAS
Malaysia	158342	PHARMACEUTICAL COMPOSITION

Supplementary Protection Certificates for SIGNIFOR LAR KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	1290022-1	Sweden		PRODUCT NAME: PASIREOTID; REG. NO/DATE: EU/1/12/753/001 20120424
1686964	C01686964/01	Switzerland		PRODUCT NAME: PASIREOTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65148 25.02.2015
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