Tegsedi is a drug owned by Akcea Therapeutics Inc. It is protected by 6 US drug patents filed in 2018. Out of these, 4 drug patents are active and 2 have expired. Tegsedi's patents have been open to challenges since 05 October, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 29, 2031. Details of Tegsedi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9061044 | Modulation of transthyretin expression |
Apr, 2031
(6 years from now) | Active |
| US8101743 | Modulation of transthyretin expression |
Apr, 2025
(3 months from now) | Active |
| US7101993 | Oligonucleotides containing 2′-O-modified purines |
Sep, 2023
(1 year, 3 months ago) |
Expired
|
| US7015315 | Gapped oligonucleotides |
Mar, 2023
(1 year, 9 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9399774 | Modulation of transthyretin expression |
Apr, 2031
(6 years from now) | Active |
| US8697860 | Diagnosis and treatment of disease |
Apr, 2031
(6 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Tegsedi's patents.
Latest Legal Activities on Tegsedi's Patents
Given below is the list of recent legal activities going on the following patents of Tegsedi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Term Extension Application under 35 USC 156 Filed | 16 Feb, 2024 | US8101743 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Jan, 2024 | US9399774 |
| FDA Final Eligibility Letter Critical | 14 Nov, 2023 | US8101743 |
| FDA Final Eligibility Letter Critical | 14 Nov, 2023 | US9061044 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Jul, 2023 | US8101743 |
| transaction for FDA Determination of Regulatory Review Period | 28 Mar, 2023 | US9061044 |
| transaction for FDA Determination of Regulatory Review Period | 28 Mar, 2023 | US8101743 |
| transaction for FDA Determination of Regulatory Review Period | 28 Mar, 2023 | US9399774 |
| transaction for FDA Determination of Regulatory Review Period | 23 Mar, 2023 | US9061044 |
| transaction for FDA Determination of Regulatory Review Period | 23 Mar, 2023 | US9399774 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Tegsedi and ongoing litigations to help you estimate the early arrival of Tegsedi generic.
Tegsedi's Litigations
Tegsedi been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 18, 2000, against patent number US7015315. The petitioner , challenged the validity of this patent, with COOK et al as the respondent. Click below to track the latest information on how companies are challenging Tegsedi's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7015315 | September, 2004 |
Decision
(27 Apr, 2005) | COOK et al | |
| US7015315 | October, 2000 |
Decision
(31 Oct, 2002) | COOK et al | |
FDA has granted some exclusivities to Tegsedi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tegsedi, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Tegsedi.
Exclusivity Information
Tegsedi holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Tegsedi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 05, 2023 |
| Orphan Drug Exclusivity(ODE-212) | Oct 05, 2025 |
US patents provide insights into the exclusivity only within the United States, but Tegsedi is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Tegsedi's family patents as well as insights into ongoing legal events on those patents.
Tegsedi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tegsedi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 29, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tegsedi Generics:
There are no approved generic versions for Tegsedi as of now.
About Tegsedi
Tegsedi is a drug owned by Akcea Therapeutics Inc. It is used for treating polyneuropathy in individuals with hereditary transthyretin amyloidosis. Tegsedi uses Inotersen Sodium as an active ingredient. Tegsedi was launched by Akcea Theraps in 2018.
Approval Date:
Tegsedi was approved by FDA for market use on 05 October, 2018.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Tegsedi is 05 October, 2018, its NCE-1 date is estimated to be 05 October, 2022.
Active Ingredient:
Tegsedi uses Inotersen Sodium as the active ingredient. Check out other Drugs and Companies using Inotersen Sodium ingredient
Treatment:
Tegsedi is used for treating polyneuropathy in individuals with hereditary transthyretin amyloidosis.
Dosage:
Tegsedi is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) | SOLUTION | Discontinued | SUBCUTANEOUS |