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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- What is the 5 year forecast for ENSTILAR?
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Summary for ENSTILAR
| International Patents: | 36 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 16 |
| Patent Applications: | 66 |
| Drug Prices: | Drug price information for ENSTILAR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ENSTILAR |
| What excipients (inactive ingredients) are in ENSTILAR? | ENSTILAR excipients list |
| DailyMed Link: | ENSTILAR at DailyMed |
Recent Clinical Trials for ENSTILAR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lipidor AB | Phase 3 |
| Aarhus University Hospital | Phase 4 |
| University of Alabama at Birmingham | Phase 4 |
Pharmacology for ENSTILAR
| Drug Class | Corticosteroid Vitamin D Analog |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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
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 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 | ||
| 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 | ||
| 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 |
Expired US Patents for ENSTILAR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Leo Pharma As | ENSTILAR | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 207589-001 | Oct 16, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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: ⤷ Sign Up
Brazil
Patent: 2012030653
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 00181
Estimated Expiration: ⤷ Sign Up
China
Patent: 2939078
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
Estimated Expiration: ⤷ Sign Up
Patent: 59886
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 82321
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 2865
Estimated Expiration: ⤷ Sign Up
Patent: 7260
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
Estimated Expiration: ⤷ Sign Up
Patent: 18065850
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 7691
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 12013591
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 3470
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 79852
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 79852
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 76607
Estimated Expiration: ⤷ Sign Up
Patent: 13100996
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 809
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 5521
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 79852
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1208281
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1619077
Estimated Expiration: ⤷ Sign Up
Patent: 1749514
Estimated Expiration: ⤷ Sign Up
Patent: 130109096
Estimated Expiration: ⤷ Sign Up
Patent: 160054614
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 29506
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 9785
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 |
|---|---|---|---|
| Japan | 2013075923 | PHARMACEUTICAL COMPOSITION | ⤷ Sign Up |
| Norway | 20015175 | ⤷ Sign Up | |
| Cyprus | 1113967 | ⤷ Sign Up | |
| Japan | 2015155451 | 医薬組成物 (PHARMACEUTICAL COMPOSITION) | ⤷ Sign Up |
| Spain | 2671785 | ⤷ Sign Up | |
| European Patent Office | 2579852 | COMPOSITION PHARMACEUTIQUE PULVERISABLE COMPRENANT UN VITAMINE D ANALOGUE ET UN COTICOSTEROID (A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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