Crenessity is a drug owned by Neurocrine Biosciences Inc. It is protected by 4 US drug patents filed in 2025 out of which none have expired yet. Crenessity's patents will be open to challenges from 13 December, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 09, 2041. Details of Crenessity'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. | |||
| US12128033 | Synthetic methods for preparation of 4-(2-chloro-4-methoxy-5-methylphenyl)-n-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-n-prop-2-ynyl-1,3-thiazol-2-amine |
Jun, 2041
(16 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10905690 | Treatment of congenital adrenal hyperplasia |
Jan, 2035
(9 years from now) | Active |
| US11311544 | Treatment of congenital adrenal hyperplasia |
Jan, 2035
(9 years from now) | Active |
| US11730739 | Treatment of congenital adrenal hyperplasia |
Jan, 2035
(9 years from now) | Active |
FDA has granted several exclusivities to Crenessity. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Crenessity, 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 Crenessity.
Exclusivity Information
Crenessity holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Crenessity's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 13, 2029 |
| Orphan Drug Exclusivity(ODE-503) | Dec 13, 2031 |
US patents provide insights into the exclusivity only within the United States, but Crenessity 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 Crenessity's family patents as well as insights into ongoing legal events on those patents.
Crenessity's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Crenessity's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 09, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Crenessity Generics:
There are no approved generic versions for Crenessity as of now.
About Crenessity
Crenessity is a drug owned by Neurocrine Biosciences Inc. Crenessity uses Crinecerfont as an active ingredient. Crenessity was launched by Neurocrine in 2024.
Approval Date:
Crenessity was approved by FDA for market use on 13 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 Crenessity is 13 December, 2024, its NCE-1 date is estimated to be 13 December, 2028.
Active Ingredient:
Crenessity uses Crinecerfont as the active ingredient. Check out other Drugs and Companies using Crinecerfont ingredient
Dosage:
Crenessity is available in the following dosage forms - solution form for oral use, capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG | CAPSULE | Prescription | ORAL |
| 100MG | CAPSULE | Prescription | ORAL |
| 50MG | CAPSULE | Prescription | ORAL |
| 50MG/ML | SOLUTION | Prescription | ORAL |