Daurismo is a drug owned by Pfizer Inc. It is protected by 5 US drug patents filed from 2018 to 2024 out of which none have expired yet. Daurismo's patents have been open to challenges since 21 November, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 13, 2036. Details of Daurismo'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. | |||
| US10414748 | Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate |
Apr, 2036
(11 years from now) | Active |
| US8148401 | Benzimidazole derivatives |
Jan, 2031
(6 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). | |||
| US11891372 | Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate |
Apr, 2036
(11 years from now) | Active |
| US11168066 | Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate |
Apr, 2036
(11 years from now) | Active |
| US8431597 | Benzimidazole derivatives |
Jun, 2028
(3 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Daurismo's patents.
Latest Legal Activities on Daurismo's Patents
Given below is the list of recent legal activities going on the following patents of Daurismo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 13 Mar, 2024 | US8148401 |
| transaction for FDA Determination of Regulatory Review Period | 13 Mar, 2024 | US8431597 |
| transaction for FDA Determination of Regulatory Review Period | 28 Feb, 2024 | US8431597 |
| Post Issue Communication - Certificate of Correction | 28 Feb, 2024 | US11891372 |
| transaction for FDA Determination of Regulatory Review Period | 28 Feb, 2024 | US8148401 |
| Mail Examiner Interview Summary (PTOL - 413) | 26 Feb, 2024 | US11891372 |
| Email Notification Critical | 26 Feb, 2024 | US11891372 |
| Interview Summary Record | 21 Feb, 2024 | US11891372 |
| Interview Summary - Applicant Initiated - Telephonic | 21 Feb, 2024 | US11891372 |
| Patent Issue Date Used in PTA Calculation Critical | 06 Feb, 2024 | US11891372 |
FDA has granted several exclusivities to Daurismo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Daurismo, 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 Daurismo.
Exclusivity Information
Daurismo holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Daurismo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 21, 2023 |
| Orphan Drug Exclusivity(ODE-224) | Nov 21, 2025 |
US patents provide insights into the exclusivity only within the United States, but Daurismo 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 Daurismo's family patents as well as insights into ongoing legal events on those patents.
Daurismo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Daurismo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 13, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Daurismo Generics:
There are no approved generic versions for Daurismo as of now.
About Daurismo
Daurismo is a drug owned by Pfizer Inc. It is used for treating newly-diagnosed acute myeloid leukemia in adult patients over 75 years old or with comorbidities. Daurismo uses Glasdegib Maleate as an active ingredient. Daurismo was launched by Pfizer in 2018.
Approval Date:
Daurismo was approved by FDA for market use on 21 November, 2018.
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 Daurismo is 21 November, 2018, its NCE-1 date is estimated to be 21 November, 2022.
Active Ingredient:
Daurismo uses Glasdegib Maleate as the active ingredient. Check out other Drugs and Companies using Glasdegib Maleate ingredient
Treatment:
Daurismo is used for treating newly-diagnosed acute myeloid leukemia in adult patients over 75 years old or with comorbidities.
Dosage:
Daurismo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 25MG BASE | TABLET | Prescription | ORAL |
| EQ 100MG BASE | TABLET | Prescription | ORAL |