DrugPatentWatch Database Preview
TEGSEDI Drug Profile
Which 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.
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 | 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 | ||||
| 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 | 3527200 | Start Trial |
| Spain | 2259177 | Start Trial |
| Brazil | 9206026 | Start Trial |
| Israel | 105033 | Start Trial |
| Hungary | 9300373 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TEGSEDI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 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 | 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 | 1/2019 | Austria | Start Trial | PRODUCT NAME: INOTERSEN; REGISTRATION NO/DATE: EU/1/18/1296 (MITTEILUNG) 20180710 |
| 2563920 | PA2019001 | Lithuania | Start Trial | PRODUCT NAME: INOTERSENAS; REGISTRATION NO/DATE: EU/1/18/1296 20180706 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
