Aphexda is a drug owned by Ayrmid Pharma Ltd. It is protected by 2 US drug patents filed in 2025 out of which none have expired yet. Aphexda's patents will be open to challenges from 09 September, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 29, 2041. Details of Aphexda'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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12257285 | Composition of BL-8040 |
Dec, 2041
(16 years from now) | Active |
| US12268725 | Composition of BL-8040 |
Dec, 2041
(16 years from now) | Active |
FDA has granted several exclusivities to Aphexda. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Aphexda, 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 Aphexda.
Exclusivity Information
Aphexda holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Aphexda's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 08, 2028 |
| Orphan Drug Exclusivity(ODE-442) | Sep 08, 2030 |
US patents provide insights into the exclusivity only within the United States, but Aphexda 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 Aphexda's family patents as well as insights into ongoing legal events on those patents.
Aphexda's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aphexda's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 29, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aphexda Generics:
There are no approved generic versions for Aphexda as of now.
About Aphexda
Aphexda is a drug owned by Ayrmid Pharma Ltd. Aphexda uses Motixafortide Acetate as an active ingredient. Aphexda was launched by Ayrmid Pharma in 2023.
Approval Date:
Aphexda was approved by FDA for market use on 08 September, 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 Aphexda is 08 September, 2023, its NCE-1 date is estimated to be 09 September, 2027.
Active Ingredient:
Aphexda uses Motixafortide Acetate as the active ingredient. Check out other Drugs and Companies using Motixafortide Acetate ingredient
Dosage:
Aphexda is available in powder form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 62MG BASE/VIAL | POWDER | Prescription | SUBCUTANEOUS |