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TEGSEDI Drug Profile
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See Plans and PricingWhich patents cover Tegsedi, and when can generic versions of Tegsedi launch?
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 twenty-nine patent family members in twenty-nine 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.
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: | 529 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 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 |
Pharmacology for TEGSEDI
| Drug Class | Transthyretin-directed RNA Interaction Antisense Oligonucleotide |
| Physiological Effect | Decreased RNA Integrity Increased Protein Breakdown |
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 | 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 | |||
| >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 |
|---|---|---|
| Japan | 3585583 | Start Trial |
| Australia | 2002319635 | Start Trial |
| Germany | 69333344 | Start Trial |
| Australia | 2003237260 | Start Trial |
| Australia | 2002365920 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TEGSEDI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 2563920 | LUC00096 | Luxembourg | Start Trial | 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), WHEREIN THE MODIFIED OLIGONUCLEOTIDE COMPRISES: A GAP SEGMENT CONSISTING OF TEN LINKED DEOXYNUCLEOSIDES; A 5' WING SEGMENT CONSISTING OF FIVE LINKED NUCLEOSIDES; AND A 3' WING SEGMENT CONSISTING OF FIVE LINKED NUCLEOSIDES; WHEREIN THE GAP SEGMENT IS POSITIONED BETWEEN THE 5' WING SEGMENT AND THE 3' WING SEGMENT, WHEREIN EACH NUCLEOSIDE OF EACH WING SEGMENT COMPRISES A 2'-O-METHOXYETHYL SUGAR; (...); AUTHORISATION NUMBER AND DATE: EU/1/18/1296 20180710 |
| 2563920 | CA 2019 00001 | Denmark | Start Trial | 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 | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
