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TEGSEDI Drug Profile

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Which patents cover Tegsedi, and when can generic versions of Tegsedi launch?

Tegsedi is a drug marketed by Akcea Theraps and is included in one NDA. There are six patents protecting this drug.

This drug has five hundred and twenty-eight patent family members in twenty-eight countries.

The generic ingredient in TEGSEDI is inotersen sodium. One supplier is listed for this compound. Additional details are available on the inotersen sodium profile page.

Summary for TEGSEDI

International Patents:	528
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Prior Art and Litigation Support	Order Prior Art and Litigation support for TEGSEDI
DailyMed Link:	TEGSEDI at DailyMed

Generic Entry Opportunity Date for TEGSEDI

Constraining patent/regulatory exclusivity:

INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

NDA:

211172

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.

US Patents and Regulatory Information for TEGSEDI

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
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

International Patents for TEGSEDI

Country	Patent Number	Estimated Expiration
European Patent Office	1119580
Germany	69128250
Canada	2333087
Australia	1783002

Supplementary Protection Certificates for TEGSEDI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2019001	Lithuania		PRODUCT NAME: INOTERSENAS; REGISTRATION NO/DATE: EU/1/18/1296 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	300963	Netherlands		PRODUCT NAME: MODULATION OF TRANSTHYRETIN EXPRESSION; REGISTRATION NO/DATE: EU/1/18/1296 20180710