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Last Updated: November 2, 2024

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ENSTILAR Drug Patent Profile


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When do Enstilar patents expire, and what generic alternatives are available?

Enstilar is a drug marketed by Leo Pharma As and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-six patent family members in twenty-five countries.

The generic ingredient in ENSTILAR is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.

DrugPatentWatch® Generic Entry Outlook for Enstilar

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ENSTILAR
Drug Prices for ENSTILAR

See drug prices for ENSTILAR

Recent Clinical Trials for ENSTILAR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Lipidor ABPhase 3
Aarhus University HospitalPhase 4
University of Alabama at BirminghamPhase 4

See all ENSTILAR clinical trials

Pharmacology for ENSTILAR
Paragraph IV (Patent) Challenges for ENSTILAR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ENSTILAR Topical Foam betamethasone dipropionate; calcipotriene 0.005%/0.064% 207589 1 2020-06-22

US Patents and Regulatory Information for ENSTILAR

ENSTILAR is protected by eight US patents.

Patents protecting ENSTILAR

Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical spray composition comprising a vitamind D analogue and a corticosteroid
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Patent Expiration: ⤷  Sign Up

Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 12 YEARS AND OLDER

Pharmaceutical spray composition comprising a vitamind D analogue and a corticosteroid
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 12 YEARS AND OLDER

Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ENSTILAR

When does loss-of-exclusivity occur for ENSTILAR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 11264198
Patent: A pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2012030653
Patent: composição tópica em aerosol, estável ao armazenamento e substancialmente anidra, e, recipiente pressurizado
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 00181
Patent: COMPOSITION PHARMACEUTIQUE POUR AEROSOL COMPRENANT UN ANALOGUE DE VITAMINE D ET UN CORTICOSTEROIDE (A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID)
Estimated Expiration: ⤷  Sign Up

China

Patent: 2939078
Patent: A pharmaceutical spray composition comprising a vitamin d analogue and a corticosteroid
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0150154
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 15991
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 79852
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 79852
Patent: COMPOSITION PHARMACEUTIQUE PULVERISABLE COMPRENANT UN VITAMINE D ANALOGUE ET UN COTICOSTEROID (A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID)
Estimated Expiration: ⤷  Sign Up

Patent: 59886
Patent: Composition pharmaceutique pulverisable (A pharmaceutical spray composition)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 82321
Patent: 含有維生素 類似物和皮質類固醇的藥用噴霧劑組合物 (A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN ANALOGUE AND A CORTICOSTEROID)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 2865
Patent: הרכב תרסיס רוקחי המכיל אנלוג של ויטמין d וקורטיקוסטרואיד (Pharmaceutical spray composition comprising a vitamin d analogue and a corticosteroid)
Estimated Expiration: ⤷  Sign Up

Patent: 7260
Patent: הרכב תרסיס רוקחי המכיל אנלוג של ויטמין d וקורטיקוסטרואיד (A pharmaceutical spray composition comprising a vitamin d analogue and a corticosteroid)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 45268
Estimated Expiration: ⤷  Sign Up

Patent: 58402
Estimated Expiration: ⤷  Sign Up

Patent: 03445
Estimated Expiration: ⤷  Sign Up

Patent: 13533859
Estimated Expiration: ⤷  Sign Up

Patent: 16188223
Patent: ビタミンD類似体およびコルチコステロイドを含むスプレー医薬組成物 (PHARMACEUTICAL SPRAY COMPOSITION COMPRISING VITAMIN D ANALOGUE AND CORTICOSTEROID)
Estimated Expiration: ⤷  Sign Up

Patent: 18065850
Patent: ビタミンD類似体およびコルチコステロイドを含むスプレー医薬組成物 (PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOG AND A CORTICOSTEROID)
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 7691
Patent: A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 12013591
Patent: COMPOSICION FARMACEUTICA EN AEROSOL QUE COMPRENDE ANALOGO DE VITAMINA D Y CORTICOSTEROIDE. (A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 3470
Patent: A pharmaceutical spray composition comprising a vitamin d analogue and a corticosteroid
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 79852
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 79852
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 76607
Patent: КОМПОЗИЦИЯ ФАРМАЦЕВТИЧЕСКОГО АЭРОЗОЛЯ, ВКЛЮЧАЮЩАЯ АНАЛОГ ВИТАМИНА D И КОРТИКОСТЕРОИД (PHARMACEUTICAL AEROSOL FORMULATION CONTAINING VITAMIN D ANALOGUE AND CORTICOSTEROID)
Estimated Expiration: ⤷  Sign Up

Patent: 13100996
Patent: КОМПОЗИЦИЯ ФАРМАЦЕВТИЧЕСКОГО АЭРОЗОЛЯ, ВКЛЮЧАЮЩАЯ АНАЛОГ ВИТАМИНА D И КОРТИКОСТЕРОИД
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 809
Patent: FARMACEUTSKA KOMPOZICIJA SPREJA ZA KOŽU KOJA SADRŽI ANALOG VITAMINA D I KORTIKOSTEROID (A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 5521
Patent: A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 79852
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1208281
Patent: A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1619077
Estimated Expiration: ⤷  Sign Up

Patent: 1749514
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Patent: 130109096
Patent: A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID
Estimated Expiration: ⤷  Sign Up

Patent: 160054614
Patent: 비타민 D 유사체 및 코르티코스테로이드를 포함하는 약제학적 분무 조성물 (A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 29506
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 9785
Patent: КОМПОЗИЦІЯ ФАРМАЦЕВТИЧНОГО АЕРОЗОЛЮ, ЯКА ВКЛЮЧАЄ АНАЛОГ ВІТАМІНУ D І КОРТИКОСТЕРОЇД
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ENSTILAR around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2915534 Composition pharmaceutique pour le traitement dermique du psoriasis comprenant une vitamine D et une corticostéroïde (Pharmaceutical composition for dermal use to treat psoriasis comprising a vitamin D and a corticosteroid) ⤷  Sign Up
Lithuania 3146969 ⤷  Sign Up
Spain 2529506 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.