Enstilar is a drug owned by Leo Pharma As. It is protected by 11 US drug patents filed from 2015 to 2020. Out of these, 10 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 10, 2031. Details of Enstilar's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US10130640 (Pediatric) | Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid |
Dec, 2031
(6 years from now) | Active |
|
US9119781 (Pediatric) | Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid |
Dec, 2031
(6 years from now) | Active |
| US10688108 | Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid |
Jun, 2031
(6 years from now) | Active |
| US9566286 | Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid |
Jun, 2031
(6 years from now) | Active |
| US10130640 | Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid |
Jun, 2031
(6 years from now) | Active |
| US10682364 | Pharmaceutical spray composition comprising a vitamind D analogue and a corticosteroid |
Jun, 2031
(6 years from now) | Active |
| US10716799 | Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid |
Jun, 2031
(6 years from now) | Active |
| US10660908 | Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid |
Jun, 2031
(6 years from now) | Active |
| US10617698 | Pharmaceutical spray composition comprising a vitamind D analogue and a corticosteroid |
Jun, 2031
(6 years from now) | Active |
| US9119781 | Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid |
Jun, 2031
(6 years from now) | Active |
| US6753013 | Pharmaceutical composition |
Jan, 2020
(5 years ago) |
Expired
|
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 Enstilar's patents.
Latest Legal Activities on Enstilar's Patents
Given below is the list of recent legal activities going on the following patents of Enstilar.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Jul, 2024 | US9566286 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 Nov, 2023 | US10716799 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 31 Oct, 2023 | US10688108 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Oct, 2023 | US10682364 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Oct, 2023 | US10660908 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 16 Aug, 2023 | US10617698 |
| Post Issue Communication - Certificate of Correction | 03 Jan, 2023 | US10660908 |
| Post Issue Communication - Certificate of Correction | 03 Jan, 2023 | US10617698 |
| Post Issue Communication - Certificate of Correction | 03 Jan, 2023 | US10682364 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Jan, 2023 | US9119781 |
FDA has granted several exclusivities to Enstilar. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Enstilar, 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 Enstilar.
Exclusivity Information
Enstilar holds 3 exclusivities. All of its exclusivities have expired in 2023. Details of Enstilar's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 16, 2018 |
| New Patient Population(NPP) | Jul 30, 2022 |
| Pediatric Exclusivity(PED) | Jan 30, 2023 |
Several oppositions have been filed on Enstilar's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Enstilar's generic, the next section provides detailed information on ongoing and past EP oppositions related to Enstilar patents.
Enstilar's Oppositions Filed in EPO
Enstilar has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 28, 2015, by Pentafarma Sociedade Técnico-Medicinal S.A.. This opposition was filed on patent number EP11726055A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP11726055A | Sep, 2015 | Pentafarma Sociedade Técnico-Medicinal S.A. | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Enstilar 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 Enstilar's family patents as well as insights into ongoing legal events on those patents.
Enstilar's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Enstilar's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 10, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Enstilar Generic API suppliers:
Betamethasone Dipropionate; Calcipotriene is the generic name for the brand Enstilar. 5 different companies have already filed for the generic of Enstilar, with Padagis Israel having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Enstilar's generic
How can I launch a generic of Enstilar before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Enstilar's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Enstilar'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 Enstilar -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.005%/0.064% | 22 Jun, 2020 | 1 | 21 Mar, 2023 | 10 Jun, 2031 | Eligible |
Alternative Brands for Enstilar
Enstilar which is used for treating plaque psoriasis in patients 12 years and older., has several other brand drugs in the same treatment category and using the same active ingredient (Betamethasone Dipropionate; Calcipotriene). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Betamethasone Dipropionate; Calcipotriene. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Mc2 |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Betamethasone Dipropionate; Calcipotriene, Enstilar's active ingredient. Check the complete list of approved generic manufacturers for Enstilar
About Enstilar
Enstilar is a drug owned by Leo Pharma As. It is used for treating plaque psoriasis in patients 12 years and older. Enstilar uses Betamethasone Dipropionate; Calcipotriene as an active ingredient. Enstilar was launched by Leo Pharma As in 2015.
Approval Date:
Enstilar was approved by FDA for market use on 16 October, 2015.
Active Ingredient:
Enstilar uses Betamethasone Dipropionate; Calcipotriene as the active ingredient. Check out other Drugs and Companies using Betamethasone Dipropionate; Calcipotriene ingredient
Treatment:
Enstilar is used for treating plaque psoriasis in patients 12 years and older.
Dosage:
Enstilar is available in aerosol, foam form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.064%;0.005% | AEROSOL, FOAM | Prescription | TOPICAL |