Xatmep is a drug owned by Azurity Pharmaceuticals Inc. It is protected by 6 US drug patents filed from 2017 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 02, 2033. Details of Xatmep's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10231927 | Methotrexate composition |
Jan, 2033
(8 years from now) | Active |
| US11116724 | Methotrexate composition |
Jan, 2033
(8 years from now) | Active |
| US11969503 | Methotrexate composition |
Jan, 2033
(8 years from now) | Active |
| US10610485 | Methotrexate composition |
Jan, 2033
(8 years from now) | Active |
| US9855215 | Methotrexate composition |
Jan, 2033
(8 years from now) | Active |
| US9259427 | Methotrexate composition |
Jan, 2033
(8 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 Xatmep's patents.
Latest Legal Activities on Xatmep's Patents
Given below is the list of recent legal activities going on the following patents of Xatmep.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Sep, 2023 | US10610485 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Aug, 2022 | US10231927 |
| Patent Issue Date Used in PTA Calculation | 14 Sep, 2021 | US11116724 |
| Recordation of Patent Grant Mailed | 14 Sep, 2021 | US11116724 |
| Email Notification | 26 Aug, 2021 | US11116724 |
| Issue Notification Mailed | 25 Aug, 2021 | US11116724 |
| Dispatch to FDC | 16 Aug, 2021 | US11116724 |
| Application Is Considered Ready for Issue | 16 Aug, 2021 | US11116724 |
| Issue Fee Payment Received | 10 Aug, 2021 | US11116724 |
| Issue Fee Payment Verified | 10 Aug, 2021 | US11116724 |
FDA has granted several exclusivities to Xatmep. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xatmep, 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 Xatmep.
Exclusivity Information
Xatmep holds 3 exclusivities. All of its exclusivities have expired in 2024. Details of Xatmep's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE-137) | Apr 25, 2024 |
| Orphan Drug Exclusivity(ODE-138) | Apr 25, 2024 |
| Orphan Drug Exclusivity(ODE) | Apr 25, 2024 |
US patents provide insights into the exclusivity only within the United States, but Xatmep 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 Xatmep's family patents as well as insights into ongoing legal events on those patents.
Xatmep's family patents
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Generic Launch
Generic Release Date:
Xatmep's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 02, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xatmep Generics:
Methotrexate Sodium is the generic name for the brand Xatmep. 27 different companies have already filed for the generic of Xatmep, with Pharmachemie Bv having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xatmep's generic
About Xatmep
Xatmep is a drug owned by Azurity Pharmaceuticals Inc. It is used for treating acute lymphoblastic leukemia and juvenile rheumatoid arthritis. Xatmep uses Methotrexate Sodium as an active ingredient. Xatmep was launched by Azurity in 2017.
Market Authorisation Date:
Xatmep was approved by FDA for market use on 25 April, 2017.
Active Ingredient:
Xatmep uses Methotrexate Sodium as the active ingredient. Check out other Drugs and Companies using Methotrexate Sodium ingredient
Treatment:
Xatmep is used for treating acute lymphoblastic leukemia and juvenile rheumatoid arthritis.
Dosage:
Xatmep is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 2.5MG BASE/ML | SOLUTION | Prescription | ORAL |