Xolremdi is a drug owned by X4 Pharmaceuticals Inc. It is protected by 5 US drug patents filed in 2024 out of which none have expired yet. Xolremdi's patents will be open to challenges from 26 April, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 11, 2038. Details of Xolremdi'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). | |||
| US10953003 | Methods for treating cancer |
Dec, 2036
(12 years from now) | Active |
| US11219621 | Methods for treating immunodeficiency disease |
Dec, 2036
(12 years from now) | Active |
| US10610527 | Methods for treating immunodeficiency disease |
Dec, 2036
(12 years from now) | Active |
| US11045461 | Compositions of CXCR4 inhibitors and methods of preparation and use |
Dec, 2038
(14 years from now) | Active |
| US10548889 | Compositions of CXCR4 inhibitors and methods of preparation and use |
Dec, 2038
(14 years from now) | Active |
FDA has granted several exclusivities to Xolremdi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xolremdi, 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 Xolremdi.
Exclusivity Information
Xolremdi holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Xolremdi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 26, 2029 |
| Orphan Drug Exclusivity(ODE-480) | Apr 26, 2031 |
US patents provide insights into the exclusivity only within the United States, but Xolremdi 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 Xolremdi's family patents as well as insights into ongoing legal events on those patents.
Xolremdi's Family Patents
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Generic Launch
Generic Release Date:
Xolremdi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 11, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xolremdi Generics:
There are no approved generic versions for Xolremdi as of now.
About Xolremdi
Xolremdi is a drug owned by X4 Pharmaceuticals Inc. Xolremdi uses Mavorixafor as an active ingredient. Xolremdi was launched by X4 Pharms in 2024.
Approval Date:
Xolremdi was approved by FDA for market use on 26 April, 2024.
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 Xolremdi is 26 April, 2024, its NCE-1 date is estimated to be 26 April, 2028.
Active Ingredient:
Xolremdi uses Mavorixafor as the active ingredient. Check out other Drugs and Companies using Mavorixafor ingredient
Dosage:
Xolremdi is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | CAPSULE | Prescription | ORAL |