Copiktra is a drug owned by Secura Bio Inc. It is protected by 5 US drug patents filed from 2018 to 2022 out of which none have expired yet. Copiktra's patents have been open to challenges since 24 September, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be May 17, 2032. Details of Copiktra'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. | |||
| USRE46621 | Processes for preparing isoquinolinones and solid forms of isoquinolinones |
May, 2032
(7 years from now) | Active |
| US8193182 | Substituted isoquinolin-1(2H)-ones, and methods of use thereof |
Feb, 2030
(5 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). | |||
| US11312718 | Formulations of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one |
Jan, 2032
(7 years from now) | Active |
| US9840505 | Solid forms of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1 (2H)-one and methods of use thereof |
Jan, 2032
(7 years from now) | Active |
| US9216982 | Certain chemical entities, compositions and methods |
Jan, 2029
(4 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 Copiktra's patents.
Latest Legal Activities on Copiktra's Patents
Given below is the list of recent legal activities going on the following patents of Copiktra.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 22 Dec, 2023 | US8193182 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 Dec, 2023 | US8193182 |
| Requirement for information sent under 37 CFR 1.750 | 18 Aug, 2023 | US8193182 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Jun, 2023 | US9216982 |
| Patent Issue Date Used in PTA Calculation Critical | 26 Apr, 2022 | US11312718 |
| Recordation of Patent Grant Mailed Critical | 26 Apr, 2022 | US11312718 |
| Letter from FDA or Dept of Agriculture re PTE application | 13 Apr, 2022 | US8193182 |
| Email Notification Critical | 07 Apr, 2022 | US11312718 |
| Issue Notification Mailed Critical | 06 Apr, 2022 | US11312718 |
| Mail Miscellaneous Communication to Applicant | 04 Apr, 2022 | US11312718 |
FDA has granted several exclusivities to Copiktra. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Copiktra, 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 Copiktra.
Exclusivity Information
Copiktra holds 3 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Copiktra's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 24, 2023 |
| Orphan Drug Exclusivity(ODE-208) | Sep 24, 2025 |
| Orphan Drug Exclusivity(ODE-209) | Sep 24, 2025 |
US patents provide insights into the exclusivity only within the United States, but Copiktra 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 Copiktra's family patents as well as insights into ongoing legal events on those patents.
Copiktra's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Copiktra's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 17, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Copiktra Generics:
There are no approved generic versions for Copiktra as of now.
About Copiktra
Copiktra is a drug owned by Secura Bio Inc. It is used for treating chronic lymphocytic leukemia, small lymphocytic leukemia, and follicular lymphoma. Copiktra uses Duvelisib as an active ingredient. Copiktra was launched by Secura in 2018.
Can you believe Copiktra received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Copiktra was approved by FDA for market use on 24 September, 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 Copiktra is 24 September, 2018, its NCE-1 date is estimated to be 24 September, 2022.
Active Ingredient:
Copiktra uses Duvelisib as the active ingredient. Check out other Drugs and Companies using Duvelisib ingredient
Treatment:
Copiktra is used for treating chronic lymphocytic leukemia, small lymphocytic leukemia, and follicular lymphoma.
Dosage:
Copiktra is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG | CAPSULE | Prescription | ORAL |
| 15MG | CAPSULE | Prescription | ORAL |