FINACEA Drug Patent Profile
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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 five 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. Nine 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.
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- What is the 5 year forecast for FINACEA?
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Summary for FINACEA
| International Patents: | 137 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 148 |
| Clinical Trials: | 12 |
| Patent Applications: | 4,129 |
| Drug Prices: | Drug price information for FINACEA |
| Drug Sales Revenues: | Drug sales revenues for FINACEA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FINACEA |
| What excipients (inactive ingredients) are in FINACEA? | FINACEA excipients list |
| DailyMed Link: | FINACEA at DailyMed |
Recent Clinical Trials for FINACEA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wake Forest University Health Sciences | Early Phase 1 |
| Clinical Research Center of the Carolinas | Phase 4 |
| Padagis LLC | Phase 3 |
Pharmacology for FINACEA
| Physiological Effect | Decreased Protein Synthesis Decreased Sebaceous Gland Activity |
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 five US patents.
Patents protecting FINACEA
Foamable composition combining a polar solvent and a hydrophobic carrier
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA
Penetrating pharmaceutical foam
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Penetrating pharmaceutical foam
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA
Antibiotic kit and composition and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA
Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
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 | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Leo Pharma As | FINACEA | azelaic acid | GEL;TOPICAL | 021470-001 | Dec 24, 2002 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | 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 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 | ⤷ Sign Up | ⤷ Sign Up |
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Leo Pharma As | FINACEA | azelaic acid | GEL;TOPICAL | 021470-001 | Dec 24, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Leo Pharma As | FINACEA | azelaic acid | GEL;TOPICAL | 021470-001 | Dec 24, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FINACEA
See the table below for patents covering FINACEA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2009211147 | Substantially non-aqueous foamable petrolatum based pharmaceutical and cosmetic compositions and their uses | ⤷ Sign Up |
| Israel | 198687 | ⤷ Sign Up | |
| Japan | 5612263 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2007102052 | ⤷ Sign Up | |
| Poland | 202454 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2009087578 | ⤷ 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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