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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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Inotersen sodium has five hundred and thirty-one patent family members in twenty-nine countries.
Summary for INOTERSEN SODIUM
| International Patents: | 531 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 1 |
| DailyMed Link: | INOTERSEN SODIUM at DailyMed |
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 | Start Trial | Start Trial | Start Trial | ||||
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for INOTERSEN SODIUM
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hungary | 217179 | Start Trial |
| European Patent Office | 0656790 | Start Trial |
| Australia | 668604 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for INOTERSEN SODIUM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2563920 | 354 1-2019 | Slovakia | Start Trial | PRODUCT NAME: INOTERSEN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1296 20180710 |
| 2563920 | 132019000000004 | Italy | Start Trial | PRODUCT NAME: INOTERSEN(TEGSEDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1296, 20180710 |
| 2563920 | 2019001 | Norway | Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
