Beqalzi is a drug owned by Beone Medicines Usa Inc. It is protected by 1 US drug patent filed in 2026 out of which none have expired yet. Beqalzi's patents will be open to challenges from 13 May, 2030. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 29, 2039. Details of Beqalzi'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. | |||
| US11420968 | Bcl-2 Inhibitors |
Apr, 2039
(12 years from now) | Active |
FDA has granted several exclusivities to Beqalzi. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Beqalzi, 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
Beqalzi.
Exclusivity Information
Beqalzi holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Beqalzi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 13, 2031 |
US patents provide insights into the exclusivity only within the United States, but
Beqalzi 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 Beqalzi's family patents as well as insights into
ongoing legal events
on those patents.
Beqalzi's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Beqalzi:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Beqalzi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 29, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Beqalzi Generics:
There are no approved generic versions for Beqalzi as of now.
About Beqalzi
Beqalzi is a drug owned by Beone Medicines Usa Inc. Beqalzi uses Sonrotoclax as an active ingredient. Beqalzi was launched by Beone Medicines in 2026.
Approval Date:
Beqalzi was approved by FDA for market use on 13 May, 2026.
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 Beqalzi is 13 May, 2026, its NCE-1 date is estimated to be 13 May, 2030.
Active Ingredient:
Beqalzi uses Sonrotoclax as the active ingredient. Check out other Drugs and Companies using Sonrotoclax ingredient
Dosage:
Beqalzi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG | TABLET | Prescription | ORAL |
| 1MG | TABLET | Prescription | ORAL |
| 80MG | TABLET | Prescription | ORAL |
| 20MG | TABLET | Prescription | ORAL |