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Inotersen sodium - Generic Drug Details

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What are the generic drug sources for inotersen sodium and what is the scope of patent protection?

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

Inotersen sodium has five hundred and twenty-nine patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for inotersen sodium

International Patents:	529
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
DailyMed Link:	inotersen sodium at DailyMed

Pharmacology for inotersen sodium

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

Synonyms for inotersen sodium

1432726-13-0

950736UC77

Inotersen sodium [USAN]

ISIS 420915 salt

UNII-950736UC77

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			Y	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
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

International Patents for inotersen sodium

Country	Patent Number	Estimated Expiration
Australia	652152
Denmark	2563920
Canada	2437887
Australia	2002346631
Hungary	9500979

Supplementary Protection Certificates for inotersen sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2563920	LUC00096	Luxembourg		PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), WHEREIN THE MODIFIED OLIGONUCLEOTIDE COMPRISES: A GAP SEGMENT CONSISTING OF TEN LINKED DEOXYNUCLEOSIDES; A 5' WING SEGMENT CONSISTING OF FIVE LINKED NUCLEOSIDES; AND A 3' WING SEGMENT CONSISTING OF FIVE LINKED NUCLEOSIDES; WHEREIN THE GAP SEGMENT IS POSITIONED BETWEEN THE 5' WING SEGMENT AND THE 3' WING SEGMENT, WHEREIN EACH NUCLEOSIDE OF EACH WING SEGMENT COMPRISES A 2'-O-METHOXYETHYL SUGAR; (...); AUTHORISATION NUMBER AND DATE: EU/1/18/1296 20180710
2563920	CA 2019 00001	Denmark		PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710
2563920	1/2019	Austria		PRODUCT NAME: INOTERSEN; REGISTRATION NO/DATE: EU/1/18/1296 (MITTEILUNG) 20180710
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	PA2019001	Lithuania		PRODUCT NAME: INOTERSENAS; REGISTRATION NO/DATE: EU/1/18/1296 20180706