Leqselvi is a drug owned by Sun Pharmaceutical Industries Inc. It is protected by 3 US drug patents filed in 2024 out of which none have expired yet. Leqselvi's patents will be open to challenges from 25 July, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be May 21, 2041. Details of Leqselvi'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). | |||
| US11919907 | Deuterated JAK inhibitor and uses thereof |
May, 2041
(16 years from now) | Active |
| US10561659 | Treatment of hair loss disorders with deuterated JAK inhibitors |
May, 2037
(12 years from now) | Active |
| US12076323 | Treatment of hair loss disorders with deuterated JAK inhibitors |
May, 2037
(12 years from now) | Active |
FDA has granted several exclusivities to Leqselvi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Leqselvi, 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 Leqselvi.
Exclusivity Information
Leqselvi holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Leqselvi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 25, 2029 |
US patents provide insights into the exclusivity only within the United States, but Leqselvi 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 Leqselvi's family patents as well as insights into ongoing legal events on those patents.
Leqselvi's Family Patents
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Generic Launch
Generic Release Date:
Leqselvi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 21, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Leqselvi Generics:
There are no approved generic versions for Leqselvi as of now.
About Leqselvi
Leqselvi is a drug owned by Sun Pharmaceutical Industries Inc. Leqselvi uses Deuruxolitinib Phosphate as an active ingredient. Leqselvi was launched by Sun Pharm Inds Inc in 2024.
Approval Date:
Leqselvi was approved by FDA for market use on 25 July, 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 Leqselvi is 25 July, 2024, its NCE-1 date is estimated to be 25 July, 2028.
Active Ingredient:
Leqselvi uses Deuruxolitinib Phosphate as the active ingredient. Check out other Drugs and Companies using Deuruxolitinib Phosphate ingredient
Dosage:
Leqselvi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 8MG BASE | TABLET | Prescription | ORAL |