Agamree is a drug owned by Catalyst Pharmaceuticals Inc. It is protected by 6 US drug patents filed in 2023 out of which none have expired yet. Agamree's patents will be open to challenges from 27 October, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 16, 2040. Details of Agamree'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. | |||
| US11382922 | Aqueous oral pharmaceutical suspension compositions |
Jul, 2040
(15 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11471471 | Aqueous oral pharmaceutical suspension compositions |
Mar, 2040
(15 years from now) | Active |
| US11690853 | Non-hormonal steroid modulators of NF-κβ for treatment of disease |
Mar, 2033
(8 years from now) | Active |
| US10857161 | Non-hormonal steroid modulators of NF-kB for treatment of disease |
May, 2029
(4 years from now) | Active |
| US8334279 | Non-hormonal steroid modulators of NF-κB for treatment of disease |
May, 2029
(4 years from now) | Active |
| US11833159 | Non-hormonal steroid modulators of NF-kB for treatment of disease |
May, 2029
(4 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 Agamree's patents.
Latest Legal Activities on Agamree's Patents
Given below is the list of recent legal activities going on the following patents of Agamree.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 10 Jun, 2024 | US10857161 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 05 Jun, 2024 | US8334279 |
| Second letter to regulating agency to determine regulatory review period | 15 May, 2024 | US10857161 |
| Second letter to regulating agency to determine regulatory review period | 15 May, 2024 | US11690853 |
| Second letter to regulating agency to determine regulatory review period | 15 May, 2024 | US8334279 |
| Letter from FDA or Dept of Agriculture re PTE application | 08 May, 2024 | US11690853 |
| Letter from FDA or Dept of Agriculture re PTE application | 08 May, 2024 | US8334279 |
| Letter from FDA or Dept of Agriculture re PTE application | 08 May, 2024 | US10857161 |
| Initial letter Re: PTE Application to regulating agency | 22 Dec, 2023 | US10857161 |
| Initial letter Re: PTE Application to regulating agency | 22 Dec, 2023 | US11690853 |
FDA has granted several exclusivities to Agamree. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Agamree, 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 Agamree.
Exclusivity Information
Agamree holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Agamree's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 26, 2028 |
| Orphan Drug Exclusivity(ODE-450) | Oct 26, 2030 |
US patents provide insights into the exclusivity only within the United States, but Agamree 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 Agamree's family patents as well as insights into ongoing legal events on those patents.
Agamree's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Agamree's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 16, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Agamree Generics:
There are no approved generic versions for Agamree as of now.
About Agamree
Agamree is a drug owned by Catalyst Pharmaceuticals Inc. It is used for treating Duchenne Muscular Dystrophy. Agamree uses Vamorolone as an active ingredient. Agamree was launched by Catalyst Pharms in 2023.
Approval Date:
Agamree was approved by FDA for market use on 26 October, 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 Agamree is 26 October, 2023, its NCE-1 date is estimated to be 27 October, 2027.
Active Ingredient:
Agamree uses Vamorolone as the active ingredient. Check out other Drugs and Companies using Vamorolone ingredient
Treatment:
Agamree is used for treating Duchenne Muscular Dystrophy.
Dosage:
Agamree is available in suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG/ML | SUSPENSION | Prescription | ORAL |