TEGSEDI Drug Patent Profile
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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 four patents protecting this drug.
This drug has thirty-four patent family members in twenty-four 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.
DrugPatentWatch® Generic Entry Outlook for Tegsedi
Tegsedi was eligible for patent challenges on October 5, 2022.
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
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Questions you can ask:
- What is the 5 year forecast for TEGSEDI?
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Summary for TEGSEDI
| International Patents: | 34 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| Drug Prices: | Drug price information for TEGSEDI |
| What excipients (inactive ingredients) are in TEGSEDI? | TEGSEDI excipients list |
| DailyMed Link: | TEGSEDI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TEGSEDI
*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 |
|---|---|
| Ionis Pharmaceuticals, Inc. | Phase 3 |
| Akcea Therapeutics | Phase 3 |
| Ionis Pharmaceuticals, Inc. | Phase 2/Phase 3 |
Pharmacology for TEGSEDI
| Drug Class | Antisense Oligonucleotide Transthyretin-directed RNA Interaction |
| Physiological Effect | Decreased RNA Integrity Increased Protein Breakdown |
US Patents and Regulatory Information for TEGSEDI
TEGSEDI is protected by four US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TEGSEDI is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting TEGSEDI
Modulation of transthyretin expression
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Diagnosis and treatment of disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Modulation of transthyretin expression
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Modulation of transthyretin expression
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN AMYLOIDOSIS
FDA Regulatory Exclusivity protecting TEGSEDI
INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Exclusivity Expiration: ⤷ Sign Up
| 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 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 TEGSEDI
| 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 TEGSEDI
When does loss-of-exclusivity occur for TEGSEDI?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Brazil
Patent: 2012027547
Patent: 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
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 97792
Patent: MODULATION DE L'EXPRESSION DE LA TRANSTHYRETINE (MODULATION OF TRANSTHYRETIN EXPRESSION)
Estimated Expiration: ⤷ Sign Up
Patent: 94063
Patent: MODULATION DE L'EXPRESSION DE LA TRANSTHYRETINE (MODULATION OF TRANSTHYRETIN EXPRESSION)
Estimated Expiration: ⤷ Sign Up
China
Patent: 3038345
Patent: Modulation of transthyretin expression
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0170737
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 19070
Estimated Expiration: ⤷ Sign Up
Patent: 19001
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 63920
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 63920
Patent: MODULATION DE L'EXPRESSION DE LA TRANSTHYRÉTINE (MODULATION OF TRANSTHYRETIN EXPRESSION)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 31909
Estimated Expiration: ⤷ Sign Up
Patent: 900001
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 2697
Patent: איפנון הביטוי של טרנסתירטין (Modulation of transthyretin expression)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 96175
Estimated Expiration: ⤷ Sign Up
Patent: 13526860
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 563920
Estimated Expiration: ⤷ Sign Up
Patent: 2019001
Estimated Expiration: ⤷ Sign Up
Patent: 63920
Estimated Expiration: ⤷ Sign Up
Luxembourg
Patent: 0096
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 3559
Patent: MODULACION DE LA EXPRESION DE TRANSTIRETINA. (MODULATION OF TRANSTHYRETIN EXPRESSION.)
Estimated Expiration: ⤷ Sign Up
Patent: 12012624
Patent: MODULACION DE LA EXPRESION DE TRANSTIRETINA. (MODULATION OF TRANSTHYRETIN EXPRESSION.)
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 0963
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 3339
Patent: Modulation of transthyretin expression
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 19001
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 63920
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 63920
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 92669
Patent: МОДУЛЯЦИЯ ЭКСПРЕССИИ ТРАНСТИРЕТИНА (MODULATION OF EXPRESSION OF TRANSTHYRETIN)
Estimated Expiration: ⤷ Sign Up
Patent: 12150394
Patent: МОДУЛЯЦИЯ ЭКСПРЕССИИ ТРАНСТИРЕТИНА
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 011
Patent: MODULACIJA EKSPRESIJE TRANSTIRETINA (MODULATION OF TRANSTHYRETIN EXPRESSION)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 63920
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1835386
Estimated Expiration: ⤷ Sign Up
Patent: 130098162
Patent: MODULATION OF TRANSTHYRETIN EXPRESSION
Estimated Expiration: ⤷ Sign Up
Patent: 180026798
Patent: 트랜스티레틴 발현의 조절 (MODULATION OF TRANSTHYRETIN EXPRESSION)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 25689
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering TEGSEDI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 4848793 | ⤷ Sign Up | |
| Australia | 2003251387 | ⤷ Sign Up | |
| Australia | 715760 | ⤷ Sign Up | |
| Germany | 69433626 | ⤷ Sign Up | |
| Australia | 3892395 | ⤷ Sign Up | |
| Australia | 2002350042 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TEGSEDI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2563920 | 1/2019 | Austria | ⤷ Sign Up | PRODUCT NAME: INOTERSEN; REGISTRATION NO/DATE: EU/1/18/1296 (MITTEILUNG) 20180710 |
| 2563920 | 1990001-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: INOTERSEN AND SALTS THEREOF; 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 | CR 2019 00001 | Denmark | ⤷ Sign Up | PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710 |
| 2563920 | 122019000001 | Germany | ⤷ Sign Up | 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 | 19C1000 | France | ⤷ Sign Up | PRODUCT NAME: INOTERSEN ET SES SELS; 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.
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