Eucrisa Patent Expiration

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

(5 years from now)

Active
US8039451

(Pediatric)

Boron-containing small molecules
Dec, 2029

(5 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

(2 years from now)

Active
US9682092 Boron-containing small molecules as anti-inflammatory agents
Feb, 2027

(2 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 Eucrisa's patents.

Given below is the list of recent legal activities going on the following patents of Eucrisa.

Activity Date Patent Number
Patent litigations
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 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 16 Sep, 2019 US8039451
FDA Final Eligibility Letter 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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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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

Eucrisa has patent protection in a total of 27 countries. It's US patent count contributes only to 27.2% of its total global patent coverage. Click below to unlock the full patent family tree for Eucrisa.

Family Patents

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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