INOTERSEN SODIUM - Generic Drug Details
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What are the generic 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 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
*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
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | ⤷ Sign Up | ⤷ Sign Up |
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for INOTERSEN SODIUM
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Netherlands | 300963 | ⤷ Sign Up | |
| Denmark | 2563920 | ⤷ Sign Up | |
| Hungary | S1900001 | ⤷ Sign Up | |
| Slovenia | 2563920 | ⤷ Sign Up | |
| Canada | 2994063 | MODULATION DE L'EXPRESSION DE LA TRANSTHYRETINE (MODULATION OF TRANSTHYRETIN EXPRESSION) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INOTERSEN SODIUM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2563920 | CA 2019 00001 | Denmark | ⤷ Sign Up | 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 | 354 1-2019 | Slovakia | ⤷ Sign Up | PRODUCT NAME: INOTERSEN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1296 20180710 |
| 2563920 | 2019/001 | Ireland | ⤷ Sign Up | PRODUCT NAME: INOTERSEN AND SALTS THEREOF; REGISTRATION NO/DATE: EU/1/18/1296 20180710 |
| 2563920 | 1/2019 | Austria | ⤷ Sign Up | PRODUCT NAME: INOTERSEN; REGISTRATION NO/DATE: EU/1/18/1296 (MITTEILUNG) 20180710 |
| 2563920 | 2019C/001 | Belgium | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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