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-three patent family members in twenty-four countries.
One supplier is listed for this compound.
Summary for INOTERSEN SODIUM
| International Patents: | 33 |
| 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
Generic Entry Date for INOTERSEN SODIUM*:
Constraining patent/regulatory exclusivity:
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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for INOTERSEN SODIUM
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 2012012624 | MODULACION DE LA EXPRESION DE TRANSTIRETINA. (MODULATION OF TRANSTHYRETIN EXPRESSION.) | ⤷ Try a Trial |
| Slovenia | 2563920 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2011139917 | ⤷ Try a Trial | |
| Brazil | 112012027547 | composto compreendendo oligonucleotídeo, composição, e seus usos para prevenir tratar, melhorar ou retardar a progressão da amiloidose transtirretina ou para reduzir a expressão de mrna ou de proteína de transtirretina | ⤷ Try a Trial |
| South Korea | 101835386 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INOTERSEN SODIUM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2563920 | 300963 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: INOTERSEN OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1296 20180710 |
| 2563920 | 2019001 | Norway | ⤷ Try a Trial | PRODUCT NAME: FORBINDELSE OMFATTENDE ET MODIFISERT OLIGONUKLEOTID SOM HAR EN NUKLEOBASESEKVENS BESTAENDE AV 20 KOBLEDE NUKLEOSIDER IFOELGE EP B1 2563920 KRAV 1 (SEQ ID NO: 80), HVOR DET MODIFISERTE OLIGONUKLEOTIDET OMFATTER: ET AVSTANDSSEGMENT BESTAENDE AV TI KOBLEDE DEOKSYNUKLEOSIDER; ET 5'- VINGESEGMENT BESTAENDE AV FEM KOBLEDE NUKLEOSIDER; OG ET 3'-VINGESEGMENT BESTAENDE AV FEM KOBLEDE NUKLEOSIDER; HVOR AVSTANDSSEGMENTET ER PLASSERT MELLOM 5'- VINGESEGMENTET OG 3'- VINGESEGMENTET, HVOR HVERT NUKLEOSID AV HVERT VINGESEGMENT OMFATTER ET 2'- 0-METOKSYETYLSUKKER; HVOR HVER CYTOSIN AV DET MODIFISERTE OLIGONUKLEOTID ER EN 5-METYLCYTOSIN, OG HVOR HVER INTERNUKLEOSID-BINDING AV DET MODIFISERTE OL |
| 2563920 | PA2019001,C2563920 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: INOTERSENAS IR JO DRUSKOS; REGISTRATION NO/DATE: EU/1/18/1296 20180706 |
| 2563920 | C20190002 00303 | Estonia | ⤷ Try a Trial | PRODUCT NAME: INOTERSEEN;REG NO/DATE: EU/1/18/1296 10.07.2018 |
| 2563920 | 2019/001 | Ireland | ⤷ Try a Trial | PRODUCT NAME: INOTERSEN AND SALTS THEREOF; REGISTRATION NO/DATE: EU/1/18/1296 20180710 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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