Ensacove is a drug owned by Xcovery Holdings Inc. It is protected by 4 US drug patents filed in 2025 out of which none have expired yet. Ensacove's patents will be open to challenges from 18 December, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 01, 2037. Details of Ensacove'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. | |||
| US10899744 | Crystalline form of compound suppressing protein kinase activity, and application thereof |
Jun, 2037
(12 years from now) | Active |
| US9126947 | Substituted pyridazine carboxamide compounds |
Nov, 2031
(6 years from now) | Active |
| US9296724 | Substituted pyridazinecarboxamides as kinase inhibitors |
Jun, 2029
(4 years from now) | Active |
| US8551995 | Kinase inhibitor compounds |
Feb, 2029
(3 years from now) | Active |
FDA has granted several exclusivities to Ensacove. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ensacove, 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 Ensacove.
Exclusivity Information
Ensacove holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Ensacove's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 18, 2029 |
US patents provide insights into the exclusivity only within the United States, but Ensacove 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 Ensacove's family patents as well as insights into ongoing legal events on those patents.
Ensacove's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ensacove's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 01, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ensacove Generics:
There are no approved generic versions for Ensacove as of now.
About Ensacove
Ensacove is a drug owned by Xcovery Holdings Inc. Ensacove uses Ensartinib Hydrochloride as an active ingredient. Ensacove was launched by Xcovery in 2024.
Approval Date:
Ensacove was approved by FDA for market use on 18 December, 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 Ensacove is 18 December, 2024, its NCE-1 date is estimated to be 18 December, 2028.
Active Ingredient:
Ensacove uses Ensartinib Hydrochloride as the active ingredient. Check out other Drugs and Companies using Ensartinib Hydrochloride ingredient
Dosage:
Ensacove is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 25MG BASE | CAPSULE | Prescription | ORAL |
| EQ 100MG BASE | CAPSULE | Prescription | ORAL |