Amvuttra is a drug owned by Alnylam Pharmaceuticals Inc. It is protected by 13 US drug patents filed from 2022 to 2024 out of which none have expired yet. Amvuttra's patents will be open to challenges from 13 June, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 28, 2036. Details of Amvuttra'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. | |||
| US11286486 | Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases |
Jul, 2036
(11 years from now) | Active |
| US10683501 | Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases |
Jul, 2036
(11 years from now) | Active |
| US12049628 | Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases |
Jul, 2036
(11 years from now) | Active |
| US10208307 | Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases |
Jul, 2036
(11 years from now) | Active |
| US10612024 | Modified double-stranded RNA agents |
Aug, 2035
(10 years from now) | Active |
| US11401517 | Modified double-stranded RNA agents |
Aug, 2035
(10 years from now) | Active |
| US9399775 | RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases |
Nov, 2032
(7 years from now) | Active |
| US10570391 | RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases |
Nov, 2032
(7 years from now) | Active |
| US8106022 | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2029
(4 years from now) | Active |
| US9370581 | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2028
(3 years from now) | Active |
| US8828956 | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2028
(3 years from now) | Active |
| US10806791 | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2028
(3 years from now) | Active |
| US10131907 | Glycoconjugates of RNA interference agents |
Aug, 2028
(3 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 Amvuttra's patents.
Latest Legal Activities on Amvuttra's Patents
Given below is the list of recent legal activities going on the following patents of Amvuttra.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Surcharge for Late Payment, Large Entity | 11 Jun, 2024 | US10806791 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Jun, 2024 | US10806791 |
| Maintenance Fee Reminder Mailed Critical | 10 Jun, 2024 | US10806791 |
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US8828956 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US8828956 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Jan, 2024 | US9399775 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Dec, 2023 | US9370581 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Nov, 2023 | US10683501 |
| Letter from FDA or Dept of Agriculture re PTE application | 19 Oct, 2023 | US8106022 |
| Letter from FDA or Dept of Agriculture re PTE application | 19 Oct, 2023 | US10570391 |
FDA has granted several exclusivities to Amvuttra. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Amvuttra, 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 Amvuttra.
Exclusivity Information
Amvuttra holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Amvuttra's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 13, 2027 |
| Orphan Drug Exclusivity(ODE-212) | Jun 13, 2029 |
Several oppositions have been filed on Amvuttra's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Amvuttra's generic, the next section provides detailed information on ongoing and past EP oppositions related to Amvuttra patents.
Amvuttra's Oppositions Filed in EPO
Amvuttra has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 27, 2023, by Awa Sweden Ab. This opposition was filed on patent number EP17209680A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17209680A | Jan, 2023 | AWA Sweden AB | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Amvuttra 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 Amvuttra's family patents as well as insights into ongoing legal events on those patents.
Amvuttra's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Amvuttra's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 28, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Amvuttra Generics:
There are no approved generic versions for Amvuttra as of now.
About Amvuttra
Amvuttra is a drug owned by Alnylam Pharmaceuticals Inc. It is used for treating the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Amvuttra uses Vutrisiran Sodium as an active ingredient. Amvuttra was launched by Alnylam Pharms Inc in 2022.
Approval Date:
Amvuttra was approved by FDA for market use on 13 June, 2022.
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 Amvuttra is 13 June, 2022, its NCE-1 date is estimated to be 13 June, 2026.
Active Ingredient:
Amvuttra uses Vutrisiran Sodium as the active ingredient. Check out other Drugs and Companies using Vutrisiran Sodium ingredient
Treatment:
Amvuttra is used for treating the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Dosage:
Amvuttra is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |