Eucrisa is a drug owned by Anacor Pharmaceuticals Inc. It is protected by 8 US drug patents filed from 2017 to 2020 out of which none have expired yet. Eucrisa's patents have been open to challenges since 23 September, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 20, 2030. Details of Eucrisa'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. | |||
| US8039451 | Boron-containing small molecules |
Jun, 2029
(4 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). | |||
|
US8168614 (Pediatric) | Boron-containing small molecules as anti-inflammatory agents |
Jul, 2030
(5 years from now) | Active |
| US8168614 | Boron-containing small molecules as anti-inflammatory agents |
Jan, 2030
(4 years from now) | Active |
|
US8039451 (Pediatric) | Boron-containing small molecules |
Dec, 2029
(4 years from now) | Active |
|
US9682092 (Pediatric) | Boron-containing small molecules as anti-inflammatory agents |
Aug, 2027
(2 years from now) | Active |
|
US8501712 (Pediatric) | Boron-containing small molecules as anti-inflammatory agents |
Aug, 2027
(2 years from now) | Active |
| US8501712 | Boron-containing small molecules as anti-inflammatory agents |
Feb, 2027
(1 year, 9 months from now) | Active |
| US9682092 | Boron-containing small molecules as anti-inflammatory agents |
Feb, 2027
(1 year, 9 months 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 Eucrisa's patents.
Latest Legal Activities on Eucrisa's Patents
Given below is the list of recent legal activities going on the following patents of Eucrisa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Oct, 2023 | US8168614 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Mar, 2023 | US8039451 |
| Patent Term Extension Certificate Critical | 10 Dec, 2021 | US8039451 |
| Notice of Final Determination -Election Required | 12 Mar, 2021 | US8168614 |
| Notice of Final Determination -Election Required | 12 Mar, 2021 | US8039451 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Sep, 2020 | US9682092 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Sep, 2020 | US8501712 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Oct, 2019 | US8168614 |
| FDA Final Eligibility Letter Critical | 16 Sep, 2019 | US8039451 |
| FDA Final Eligibility Letter Critical | 16 Sep, 2019 | US8168614 |
FDA has granted several exclusivities to Eucrisa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Eucrisa, 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 Eucrisa.
Exclusivity Information
Eucrisa holds 4 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Eucrisa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 14, 2021 |
| New Patient Population(NPP) | Mar 23, 2023 |
| Pediatric Exclusivity(PED) | Sep 23, 2023 |
| New Dosing Schedule(D-191) | Apr 03, 2026 |
US patents provide insights into the exclusivity only within the United States, but Eucrisa 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 Eucrisa's family patents as well as insights into ongoing legal events on those patents.
Eucrisa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Eucrisa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 20, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Eucrisa Generics:
There are no approved generic versions for Eucrisa as of now.
How can I launch a generic of Eucrisa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Eucrisa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Eucrisa's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Eucrisa -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.02 | 14 Jun, 2021 | 5 | 20 Jan, 2030 |
About Eucrisa
Eucrisa is a drug owned by Anacor Pharmaceuticals Inc. It is used for managing mild to moderate atopic dermatitis. Eucrisa uses Crisaborole as an active ingredient. Eucrisa was launched by Anacor Pharms Inc in 2016.
Approval Date:
Eucrisa was approved by FDA for market use on 14 December, 2016.
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 Eucrisa is 14 December, 2016, its NCE-1 date is estimated to be 23 September, 2022.
Active Ingredient:
Eucrisa uses Crisaborole as the active ingredient. Check out other Drugs and Companies using Crisaborole ingredient
Treatment:
Eucrisa is used for managing mild to moderate atopic dermatitis.
Dosage:
Eucrisa is available in ointment form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2% | OINTMENT | Prescription | TOPICAL |