Inotersen sodium - Generic Drug Details

What are the generic sources for inotersen sodium and what is the scope of freedom to operate?

Inotersen sodium is the generic ingredient in one branded drug marketed by Akcea Theraps and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Inotersen sodium has thirty-four patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for inotersen sodium

International Patents:	34
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
DailyMed Link:	inotersen sodium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for inotersen sodium

Dosage:

SOLUTION;SUBCUTANEOUS

^*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.

Pharmacology for inotersen sodium

Drug Class	Antisense Oligonucleotide Transthyretin-directed RNA Interaction
Physiological Effect	Decreased RNA Integrity Increased Protein Breakdown

Anatomical Therapeutic Chemical (ATC) Classes for inotersen sodium

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for inotersen sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		RX	Yes	Yes
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		RX	Yes	Yes			Y
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		RX	Yes	Yes				Y
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		RX	Yes	Yes			Y	Y
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		RX	Yes	Yes

Expired US Patents for inotersen sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018

International Patents for inotersen sodium

Country	Patent Number	Title	Estimated Expiration
Portugal	2563920
Cyprus	2019001
Canada	2994063	MODULATION DE L'EXPRESSION DE LA TRANSTHYRETINE (MODULATION OF TRANSTHYRETIN EXPRESSION)
Denmark	2563920
Spain	2625689
Lithuania	PA2019001
Cyprus	1119070

Supplementary Protection Certificates for inotersen sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2563920	C201930001	Spain		PRODUCT NAME: INOTERSEN Y SUS SALES FARMACEUTICAMENTE ACEPTABLES, EN PARTICULAR LA SAL SODICA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1296; DATE OF AUTHORISATION: 20180706; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1296; DATE OF FIRST AUTHORISATION IN EEA: 20180706
2563920	2019C/001	Belgium		PRODUCT NAME: UN OLIGONUCLEOTIDE MODIFIE AYANT UNE SEQUENCE CONSTITUEE DE NUCLEOSIDES RELIES TELLE QUE DEFINIE AU BREVET EP-B1-2563920, ET SPECIFIQUEMENT L'INOTERSEN; ET SES DERIVES, TELS QUE SES SELS, EN CE COMPRIS LES SELS SODIQUES; AUTHORISATION NUMBER AND DATE: EU/1/18/1296 20180710
2563920	354 1-2019	Slovakia		PRODUCT NAME: INOTERSEN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1296 20180710
2563920	C20190002 00303	Estonia		PRODUCT NAME: INOTERSEEN;REG NO/DATE: EU/1/18/1296 10.07.2018
2563920	132019000000004	Italy		PRODUCT NAME: INOTERSEN(TEGSEDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1296, 20180710
2563920	LUC00096	Luxembourg		PRODUCT NAME: INOTERSEN AND SALTS THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1296 20180710
2563920	PA2019001	Lithuania		PRODUCT NAME: INOTERSENAS; REGISTRATION NO/DATE: EU/1/18/1296 20180706