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Last Updated: August 11, 2022

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
Anatomical Therapeutic Chemical (ATC) Classes for ENSTILAR
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D07AC Corticosteroids, potent (group III)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XC Corticosteroids, potent, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
R03BA Glucocorticoids
R03B OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R Respiratory system
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs
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 and two FDA Regulatory Exclusivities.

Patents protecting ENSTILAR

Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical spray composition comprising a vitamind D analogue and a corticosteroid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting ENSTILAR

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2012030653
Estimated Expiration: See Plans and Pricing

Canada

Patent: 00181
Estimated Expiration: See Plans and Pricing

China

Patent: 2939078
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0150154
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 15991
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 79852
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 79852
Estimated Expiration: See Plans and Pricing

Patent: 59886
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 82321
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2865
Estimated Expiration: See Plans and Pricing

Patent: 7260
Estimated Expiration: See Plans and Pricing

Japan

Patent: 45268
Estimated Expiration: See Plans and Pricing

Patent: 58402
Estimated Expiration: See Plans and Pricing

Patent: 03445
Estimated Expiration: See Plans and Pricing

Patent: 13533859
Estimated Expiration: See Plans and Pricing

Patent: 16188223
Estimated Expiration: See Plans and Pricing

Patent: 18065850
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 7691
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 12013591
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3470
Estimated Expiration: See Plans and Pricing

Poland

Patent: 79852
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 79852
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 76607
Estimated Expiration: See Plans and Pricing

Patent: 13100996
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 809
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 5521
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 79852
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1208281
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1619077
Estimated Expiration: See Plans and Pricing

Patent: 1749514
Estimated Expiration: See Plans and Pricing

Patent: 130109096
Estimated Expiration: See Plans and Pricing

Patent: 160054614
Estimated Expiration: See Plans and Pricing

Spain

Patent: 29506
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 9785
Estimated Expiration: See Plans and Pricing

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
Czech Republic 20013739 See Plans and Pricing
Japan 5886999 See Plans and Pricing
Czech Republic 303142 Farmaceutický prostredek pro dermální použití (Pharmaceutical composition for dermal use) See Plans and Pricing
South Korea 20130109096 A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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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.