pasireotide Injection

Brand(s): Signifor
Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: Novartis Pharmaceuticals Corporation (2015-03-17)
Oldest Current Product: 2012-12-14
License(s): NDA

RxNORM: INJECTION\PASIREOTIDE
FDAOB: INTRAMUSCULAR\POWDER\PASIREOTIDE PAMOATE
SUBCUTANEOUS\SOLUTION\PASIREOTIDE DIASPARTATE
SPL Active: INTRAMUSCULAR\INJECTION, POWDER, FOR SUSPENSION\PASIREOTIDE
SUBCUTANEOUS\INJECTION\PASIREOTIDE
SPL Moiety: INTRAMUSCULAR\INJECTION, POWDER, FOR SUSPENSION\PASIREOTIDE
SUBCUTANEOUS\INJECTION\PASIREOTIDE

product(s) by strength(s)

1 ml pasireotide 0.3 mg/ml injection

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	000780633	Signifor	NDA	Novartis Pharmaceuticals Corporation	2012-12-14	PASIREOTIDE	SUBCUTANEOUS	INJECTION	NDA200677	442f0d9d-5c7d-4b81-b329-d71be8cf2be2

1 ml pasireotide 0.6 mg/ml injection

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	000780634	Signifor	NDA	Novartis Pharmaceuticals Corporation	2012-12-14	PASIREOTIDE	SUBCUTANEOUS	INJECTION	NDA200677	442f0d9d-5c7d-4b81-b329-d71be8cf2be2

1 ml pasireotide 0.9 mg/ml injection

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	000780635	Signifor	NDA	Novartis Pharmaceuticals Corporation	2012-12-14	PASIREOTIDE	SUBCUTANEOUS	INJECTION	NDA200677	442f0d9d-5c7d-4b81-b329-d71be8cf2be2

pasireotide 20 mg injection

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	000780641	Signifor	NDA	Novartis Pharmaceuticals Corporation	2014-12-15	PASIREOTIDE	INTRAMUSCULAR	INJECTION, POWDER, FOR SUSPENSION	NDA203255	5504116c-d531-4d47-b160-41c6671d52aa

pasireotide 40 mg injection

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	000780642	Signifor	NDA	Novartis Pharmaceuticals Corporation	2014-12-15	PASIREOTIDE	INTRAMUSCULAR	INJECTION, POWDER, FOR SUSPENSION	NDA203255	5504116c-d531-4d47-b160-41c6671d52aa

pasireotide 60 mg injection

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	000780643	Signifor	NDA	Novartis Pharmaceuticals Corporation	2014-12-15	PASIREOTIDE	INTRAMUSCULAR	INJECTION, POWDER, FOR SUSPENSION	NDA203255	5504116c-d531-4d47-b160-41c6671d52aa

application(s)

#	id	title	applicant	approved	patent	exclusivity	approved drug
1	NDA200677	SIGNIFOR	NOVARTIS PHARMACEUTICALS CORP	2012-12-14	p7473761, SUBSTANCE p6225284, SUBSTANCE p8299209, SUBSTANCE	NEW CHEMICAL ENTITY [2017-12-14] ORPHAN DRUG EXCLUSIVITY [2019-12-14]	NDA200677_001, NDA200677_002, NDA200677_003
2	NDA203255	SIGNIFOR LAR	NOVARTIS PHARMACEUTICALS CORP	2014-12-15	p8822637, METHOD OF TREATING ACROMEGALY p7473761, SUBSTANCE p6225284, METHOD OF TREATING DISORDERS WITH AN ETIOLOGY COMPRISING OR ASSOCIATED WITH EXCESS GH-SECRETION, SUBSTANCE p7759308, SUBSTANCE	NEW CHEMICAL ENTITY [2017-12-14] NEW PRODUCT [2017-12-15] ORPHAN DRUG EXCLUSIVITY [2021-12-15]	NDA203255_001, NDA203255_002, NDA203255_003

application drug(s)

#	id	category/deprecated	ingredient strength(s)	route	dose form	rld	approved	application
1	NDA200677_001	RX	PASIREOTIDE DIASPARTATE (EQ 0.3MG BASE/ML)	SUBCUTANEOUS	SOLUTION	False	2012-12-14	SIGNIFOR
2	NDA200677_002	RX	PASIREOTIDE DIASPARTATE (EQ 0.6MG BASE/ML)	SUBCUTANEOUS	SOLUTION	False	2012-12-14	SIGNIFOR
3	NDA200677_003	RX	PASIREOTIDE DIASPARTATE (EQ 0.9MG BASE/ML)	SUBCUTANEOUS	SOLUTION	True	2012-12-14	SIGNIFOR
4	NDA203255_001	RX	PASIREOTIDE PAMOATE (EQ 20MG BASE/VIAL)	INTRAMUSCULAR	POWDER	False	2014-12-15	SIGNIFOR LAR
5	NDA203255_002	RX	PASIREOTIDE PAMOATE (EQ 40MG BASE/VIAL)	INTRAMUSCULAR	POWDER	False	2014-12-15	SIGNIFOR LAR
6	NDA203255_003	RX	PASIREOTIDE PAMOATE (EQ 60MG BASE/VIAL)	INTRAMUSCULAR	POWDER	True	2014-12-15	SIGNIFOR LAR

patent(s)

#	id	expiration date	application(s)
1	p6225284 (view patent)	2016-06-28	NDA200677, NDA203255
2	p7473761 (view patent)	2025-07-29	NDA200677, NDA203255
3	p7759308 (view patent)	2026-10-25	NDA203255
4	p8299209 (view patent)	2025-12-27	NDA200677
5	p8822637 (view patent)	2023-08-06	NDA203255

spl(s)

#	id	title	category	type	labeler	last update	version	product(s)
1	442f0d9d-5c7d-4b81-b329-d71be8cf2be2 (view SPL)	These highlights do not include all the information needed to use SIGNIFOR safely and effectively. See full prescribing information for SIGNIFOR. SIGNIFOR (pasireotide) injection, for subcutaneous use Initial U.S. Approval: 2012	prescription	Human Prescription	Novartis Pharmaceuticals Corporation	2015-03-17	2	000780633, 000780634, 000780635
2	5504116c-d531-4d47-b160-41c6671d52aa (view SPL)	These highlights do not include all the information needed to use SIGNIFOR LAR safely and effectively. See full prescribing information for SIGNIFOR LAR. SIGNIFOR LAR (pasireotide) for injectable suspension, for intramuscular use Initial U.S. Approval: 2012	prescription	Human Prescription	Novartis Pharmaceuticals Corporation	2014-12-15	2	000780641, 000780642, 000780643

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII