Wainua (autoinjector) is a drug owned by Astrazeneca Ab. It is protected by 4 US drug patents filed in 2024 out of which none have expired yet. Wainua (Autoinjector)'s patents will be open to challenges from 22 December, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 25, 2034. Details of Wainua (autoinjector)'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. | |||
| US10683499 | Compositions and methods for modulating TTR expression |
Aug, 2034
(9 years from now) | Active |
| US9127276 | Conjugated antisense compounds and their use |
May, 2034
(9 years from now) | Active |
| US9181549 | Conjugated antisense compounds and their use |
May, 2034
(9 years from now) | Active |
| US8101743 | Modulation of transthyretin expression |
Apr, 2025
(3 months 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 Wainua (autoinjector)'s patents.
Latest Legal Activities on Wainua (autoinjector)'s Patents
Given below is the list of recent legal activities going on the following patents of Wainua (autoinjector).
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Term Extension Application under 35 USC 156 Filed | 16 Feb, 2024 | US9181549 |
| Patent Term Extension Application under 35 USC 156 Filed | 16 Feb, 2024 | US8101743 |
| Patent Term Extension Application under 35 USC 156 Filed | 16 Feb, 2024 | US10683499 |
| Patent Term Extension Application under 35 USC 156 Filed | 16 Feb, 2024 | US9127276 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 Nov, 2023 | US10683499 |
| FDA Final Eligibility Letter Critical | 14 Nov, 2023 | US8101743 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Jul, 2023 | US8101743 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Apr, 2023 | US9181549 |
| transaction for FDA Determination of Regulatory Review Period | 28 Mar, 2023 | US8101743 |
| transaction for FDA Determination of Regulatory Review Period | 23 Mar, 2023 | US8101743 |
FDA has granted several exclusivities to Wainua (autoinjector). Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Wainua (autoinjector), 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 Wainua (autoinjector).
Exclusivity Information
Wainua (autoinjector) holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Wainua (autoinjector)'s exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 21, 2028 |
| Orphan Drug Exclusivity(ODE-461) | Dec 21, 2030 |
US patents provide insights into the exclusivity only within the United States, but Wainua (autoinjector) 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 Wainua (autoinjector)'s family patents as well as insights into ongoing legal events on those patents.
Wainua (autoinjector)'s Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Wainua (autoinjector)'s generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 25, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Wainua (autoinjector) Generics:
There are no approved generic versions for Wainua (autoinjector) as of now.
Alternative Brands for Wainua (autoinjector)
Wainua (autoinjector) which is used for treating polyneuropathy associated with hereditary transthyretin-mediated amyloidosis., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Alnylam Pharms Inc |
| |||
About Wainua (autoinjector)
Wainua (Autoinjector) is a drug owned by Astrazeneca Ab. It is used for treating polyneuropathy associated with hereditary transthyretin-mediated amyloidosis. Wainua (Autoinjector) uses Eplontersen Sodium as an active ingredient. Wainua (Autoinjector) was launched by Astrazeneca Ab in 2023.
Approval Date:
Wainua (autoinjector) was approved by FDA for market use on 21 December, 2023.
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 Wainua (autoinjector) is 21 December, 2023, its NCE-1 date is estimated to be 22 December, 2027.
Active Ingredient:
Wainua (autoinjector) uses Eplontersen Sodium as the active ingredient. Check out other Drugs and Companies using Eplontersen Sodium ingredient
Treatment:
Wainua (autoinjector) is used for treating polyneuropathy associated with hereditary transthyretin-mediated amyloidosis.
Dosage:
Wainua (autoinjector) is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) | SOLUTION | Prescription | SUBCUTANEOUS |