Claim Your New User Special: Get your second month free ▶ Second Month Free

Serving leading biopharmaceutical companies globally:

Merck
McKinsey
Boehringer Ingelheim
Colorcon
Mallinckrodt
AstraZeneca

Last Updated: May 24, 2022

FINACEA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

When do Finacea patents expire, and when can generic versions of Finacea launch?

Finacea is a drug marketed by Leo Pharma As and is included in two NDAs. There are eight patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-seven patent family members in twenty countries.

The generic ingredient in FINACEA is azelaic acid. There are eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Finacea

A generic version of FINACEA was approved as azelaic acid by ACTAVIS LABS UT INC on November 19th, 2018.

  Sign up for a Free Trial

Drug patent expirations by year for FINACEA
Drug Prices for FINACEA

See drug prices for FINACEA

Drug Sales Revenue Trends for FINACEA

See drug sales revenues for FINACEA

Recent Clinical Trials for FINACEA

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

SponsorPhase
Clinical Research Center of the CarolinasPhase 4
DPT Laboratories, Ltd.Phase 3
Perrigo CompanyPhase 3

See all FINACEA clinical trials

Paragraph IV (Patent) Challenges for FINACEA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FINACEA Topical Foam azelaic acid 15% 207071 1 2017-09-14
FINACEA Gel azelaic acid 15% 021470 1 2012-07-27

US Patents and Regulatory Information for FINACEA

FINACEA is protected by eight US patents.

Patents protecting FINACEA

Foamable composition combining a polar solvent and a hydrophobic carrier
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA

Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Penetrating pharmaceutical foam
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Penetrating pharmaceutical foam
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA

Foamable carriers
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Foamable composition and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antibiotic kit and composition and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA

Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
Patent Number: See Plans and Pricing
Patent 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 FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 AB 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

Expired US Patents for FINACEA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 See Plans and Pricing See Plans and Pricing
Leo Pharma As FINACEA azelaic acid GEL;TOPICAL 021470-001 Dec 24, 2002 See Plans and Pricing See Plans and Pricing
Leo Pharma As FINACEA azelaic acid GEL;TOPICAL 021470-001 Dec 24, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FINACEA

When does loss-of-exclusivity occur for FINACEA?

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

Australia

Patent: 03279493
Estimated Expiration: See Plans and Pricing

Patent: 04261063
Estimated Expiration: See Plans and Pricing

Patent: 04266502
Estimated Expiration: See Plans and Pricing

Patent: 04313285
Estimated Expiration: See Plans and Pricing

Patent: 04321183
Estimated Expiration: See Plans and Pricing

Patent: 05204341
Estimated Expiration: See Plans and Pricing

Patent: 05204347
Estimated Expiration: See Plans and Pricing

Patent: 06201878
Estimated Expiration: See Plans and Pricing

Patent: 06273697
Estimated Expiration: See Plans and Pricing

Patent: 06283225
Estimated Expiration: See Plans and Pricing

Patent: 06298442
Estimated Expiration: See Plans and Pricing

Patent: 06313443
Estimated Expiration: See Plans and Pricing

Patent: 06339311
Estimated Expiration: See Plans and Pricing

Patent: 07355106
Estimated Expiration: See Plans and Pricing

Patent: 07356328
Estimated Expiration: See Plans and Pricing

Patent: 09211147
Estimated Expiration: See Plans and Pricing

Patent: 10219295
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 14916
Estimated Expiration: See Plans and Pricing

Patent: 0412975
Estimated Expiration: See Plans and Pricing

Patent: 0417287
Estimated Expiration: See Plans and Pricing

Patent: 0612428
Estimated Expiration: See Plans and Pricing

Patent: 0612429
Estimated Expiration: See Plans and Pricing

Patent: 0612448
Estimated Expiration: See Plans and Pricing

Canada

Patent: 02986
Estimated Expiration: See Plans and Pricing

Patent: 34372
Estimated Expiration: See Plans and Pricing

Patent: 36482
Estimated Expiration: See Plans and Pricing

Patent: 49505
Estimated Expiration: See Plans and Pricing

Patent: 65754
Estimated Expiration: See Plans and Pricing

Patent: 02042
Estimated Expiration: See Plans and Pricing

Patent: 06933
Estimated Expiration: See Plans and Pricing

Patent: 09948
Estimated Expiration: See Plans and Pricing

Patent: 09953
Estimated Expiration: See Plans and Pricing

Patent: 10662
Estimated Expiration: See Plans and Pricing

Patent: 11577
Estimated Expiration: See Plans and Pricing

Patent: 11703
Estimated Expiration: See Plans and Pricing

Patent: 14015
Estimated Expiration: See Plans and Pricing

Patent: 76692
Estimated Expiration: See Plans and Pricing

Patent: 57889
Estimated Expiration: See Plans and Pricing

China

Patent: 13891
Estimated Expiration: See Plans and Pricing

Patent: 56294
Estimated Expiration: See Plans and Pricing

Patent: 1267804
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 15989
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 94959
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 56009
Estimated Expiration: See Plans and Pricing

Patent: 63148
Estimated Expiration: See Plans and Pricing

Patent: 70435
Estimated Expiration: See Plans and Pricing

Patent: 99433
Estimated Expiration: See Plans and Pricing

Patent: 68648
Estimated Expiration: See Plans and Pricing

Patent: 63447
Estimated Expiration: See Plans and Pricing

Patent: 65923
Estimated Expiration: See Plans and Pricing

Patent: 88032
Estimated Expiration: See Plans and Pricing

Patent: 90679
Estimated Expiration: See Plans and Pricing

Patent: 93396
Estimated Expiration: See Plans and Pricing

Patent: 19448
Estimated Expiration: See Plans and Pricing

Patent: 19449
Estimated Expiration: See Plans and Pricing

Patent: 42870
Estimated Expiration: See Plans and Pricing

Patent: 29106
Estimated Expiration: See Plans and Pricing

Patent: 51697
Estimated Expiration: See Plans and Pricing

Patent: 73794
Estimated Expiration: See Plans and Pricing

Patent: 97065
Estimated Expiration: See Plans and Pricing

Patent: 57276
Estimated Expiration: See Plans and Pricing

Patent: 22768
Estimated Expiration: See Plans and Pricing

Patent: 94959
Estimated Expiration: See Plans and Pricing

Patent: 77043
Estimated Expiration: See Plans and Pricing

France

Patent: 84713
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 75403
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2486
Estimated Expiration: See Plans and Pricing

Patent: 8399
Estimated Expiration: See Plans and Pricing

Patent: 3092
Estimated Expiration: See Plans and Pricing

Patent: 3093
Estimated Expiration: See Plans and Pricing

Patent: 3094
Estimated Expiration: See Plans and Pricing

Patent: 3095
Estimated Expiration: See Plans and Pricing

Patent: 6923
Estimated Expiration: See Plans and Pricing

Patent: 7275
Estimated Expiration: See Plans and Pricing

Patent: 7276
Estimated Expiration: See Plans and Pricing

Patent: 7277
Estimated Expiration: See Plans and Pricing

Patent: 8602
Estimated Expiration: See Plans and Pricing

Patent: 6363
Estimated Expiration: See Plans and Pricing

Patent: 8687
Estimated Expiration: See Plans and Pricing

Patent: 8688
Estimated Expiration: See Plans and Pricing

Japan

Patent: 06505583
Estimated Expiration: See Plans and Pricing

Patent: 07503428
Estimated Expiration: See Plans and Pricing

Patent: 07508243
Estimated Expiration: See Plans and Pricing

Patent: 07516265
Estimated Expiration: See Plans and Pricing

Patent: 08539222
Estimated Expiration: See Plans and Pricing

Patent: 08540508
Estimated Expiration: See Plans and Pricing

Patent: 08540509
Estimated Expiration: See Plans and Pricing

Patent: 08540511
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05004278
Estimated Expiration: See Plans and Pricing

Patent: 06001381
Estimated Expiration: See Plans and Pricing

Patent: 06002163
Estimated Expiration: See Plans and Pricing

Patent: 06006923
Estimated Expiration: See Plans and Pricing

Patent: 07014101
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0166
Estimated Expiration: See Plans and Pricing

Poland

Patent: 94959
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 94959
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 94959
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0502171
Estimated Expiration: See Plans and Pricing

Patent: 0502180
Estimated Expiration: See Plans and Pricing

Patent: 0503298
Estimated Expiration: See Plans and Pricing

Patent: 0507018
Estimated Expiration: See Plans and Pricing

Patent: 0507019
Estimated Expiration: See Plans and Pricing

Patent: 0706383
Estimated Expiration: See Plans and Pricing

Patent: 0710619
Estimated Expiration: See Plans and Pricing

Patent: 0710621
Estimated Expiration: See Plans and Pricing

Patent: 0711243
Estimated Expiration: See Plans and Pricing

Patent: 1005630
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1108439
Estimated Expiration: See Plans and Pricing

Patent: 050083826
Estimated Expiration: See Plans and Pricing

Patent: 060113657
Estimated Expiration: See Plans and Pricing

Spain

Patent: 30390
Estimated Expiration: See Plans and Pricing

Patent: 32906
Estimated Expiration: See Plans and Pricing

Patent: 41488
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 FINACEA around the world.

Country Patent Number Title Estimated Expiration
South Africa 200502171 Foam carrier containing amphiphilic copolymeric gelling agent See Plans and Pricing
Israel 186923 ערכה סטרואידית ומרקם קצף ומגוון שימושיהם (Steroid kit and foamable composition and uses thereof) See Plans and Pricing
Czech Republic 299116 Prípravek s kyselinou azelainovou (Composition containing azelaic acid) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
McKinsey
Harvard Business School
Baxter
Johnson and Johnson
Boehringer Ingelheim

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.