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TEGSEDI Drug Profile
» See Plans and Pricing
When do Tegsedi patents expire, and what generic alternatives are available?
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 thirty-one patent family members in twenty-nine countries.
The generic ingredient in TEGSEDI is inotersen sodium. Additional details are available on the inotersen sodium profile page.
US ANDA Litigation and Generic Entry Outlook for Tegsedi
Tegsedi will be eligible for patent challenges on October 5, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 29, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for TEGSEDI
| International Patents: | 531 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 1 |
| Drug Prices: | Drug price information for TEGSEDI |
| DailyMed Link: | TEGSEDI at DailyMed |
Generic Entry Opportunity Date for TEGSEDI
Generic Entry Date for TEGSEDI*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Recent Clinical Trials for TEGSEDI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Akcea Therapeutics | Phase 3 |
| Ionis Pharmaceuticals, Inc. | Phase 3 |
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 | Start Trial | Start Trial | Y | Start Trial | |||
| 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 | Start Trial | |||
| 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 | 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 | 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 TEGSEDI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 730916 | Start Trial |
| Australia | 8440391 | Start Trial |
| European Patent Office | 0544757 | Start Trial |
| Denmark | 0517859 | Start Trial |
| Spain | 2188581 | Start Trial |
| Canada | 2074523 | Start Trial |
| Japan | 5896175 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TEGSEDI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2563920 | 1990001-8 | Sweden | Start Trial | PRODUCT NAME: INOTERSEN AND SALTS THEREOF; REG. NO/DATE: EU/1/18/1296 20180710 |
| 2563920 | 2019C/001 | Belgium | Start Trial | 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 | 122019000001 | Germany | Start Trial | PRODUCT NAME: VERBINDUNG, UMFASSEND EIN MODIFIZIERTES OLIGONUKLEOTID MIT EINER NUKLEOBASENSEQUENZ BESTEHEND AUS 20 VERKNUEPFTEN NUKLEOSIDEN GEMAESS EP B1 2563920, ANSPRUCH 1 (SEQ ID NO: 80), WOBEI DAS MODIFIZIERTE OLIGONUKLEOTID UMFASST: EIN LUECKENSEGMENT, DAS AUS ZEHN VERKNUEPFTEN DESOXYNUKLEOSIDEN BESTEHT ; EIN 5'-FLUEGELSEGMENT BESTEHEND AUS FUENF VERKNUEPFTEN NUKLEOSIDEN; UND EIN 3'-FLUEGELSEGMENT BESTEHEND AUS FUEN; REGISTRATION NO/DATE: EU/1/18/1296 20180706 |
| 2563920 | PA2019001,C2563920 | Lithuania | Start Trial | PRODUCT NAME: INOTERSENAS IR JO DRUSKOS; REGISTRATION NO/DATE: EU/1/18/1296 20180706 |
| 2563920 | C201930001 | Spain | Start Trial | PRODUCT NAME: INOTERSEN Y SUS SALES FARMACEUTICAMENTE ACEPTABLES, EN PARTICULAR LA SAL SODICA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1296; DATE OF AUTHORISATION: 20180706; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1296; DATE OF FIRST AUTHORISATION IN EEA: 20180706 |
| 2563920 | PA2019001 | Lithuania | Start Trial | PRODUCT NAME: INOTERSENAS; REGISTRATION NO/DATE: EU/1/18/1296 20180706 |
| 2563920 | 300963 | Netherlands | Start Trial | PRODUCT NAME: MODULATION OF TRANSTHYRETIN EXPRESSION; REGISTRATION NO/DATE: EU/1/18/1296 20180710 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
