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Generic Finacea Availability

Finacea is a brand name of azelaic acid topical, approved by the FDA in the following formulation(s):

FINACEA (azelaic acid - aerosol, foam;topical)

  • Manufacturer: LEO PHARMA AS
    Approval date: July 29, 2015
    Strength(s): 15% [RLD]

FINACEA (azelaic acid - gel;topical)

  • Manufacturer: LEO PHARMA AS
    Approval date: December 24, 2002
    Strength(s): 15% [RLD] [AB]

Has a generic version of Finacea been approved?

A generic version of Finacea has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Finacea and have been approved by the FDA:

azelaic acid gel;topical

  • Manufacturer: ACTAVIS LABS UT INC
    Approval date: November 19, 2018
    Strength(s): 15% [AB]
  • Manufacturer: GLENMARK PHARMS
    Approval date: November 19, 2018
    Strength(s): 15% [AB]
  • Manufacturer: TOLMAR
    Approval date: November 19, 2018
    Strength(s): 15% [AB]

Note: No generic formulation of the following product is available.

  • azelaic acid - aerosol, foam;topical

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Finacea. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Foamable composition combining a polar solvent and a hydrophobic carrier
    Patent 10,117,812
    Issued: November 6, 2018
    Assignee(s): Foamix Pharmaceuticals Ltd.

    The present invention relates to a foamable vehicle or cosmetic or pharmaceutical composition, comprising: (1) an organic carrier, at a concentration of 10% to 70% by weight, wherein said organic carrier concurrently comprises: (i) at least one hydrophobic organic carrier, and (ii) at least one polar solvent; (2) at least one surface-active agent; (3) water; and (4) at least one liquefied or compressed gas propellant at a concentration of 3% to 25% by weight of the total composition. The present invention further provides a method of treating, alleviating or preventing a disorder of mammalian subject, comprising administering the above-mentioned compositions to an afflicted target site.

    Patent expiration dates:

    • October 18, 2027
      ✓ 
      Patent use: TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA
      ✓ 
      Drug product
  • Mousse composition
    Patent 6,730,288
    Issued: May 4, 2004
    Inventor(s): Albert Zorko; Abram
    Assignee(s): Connetics Australia Pty Ltd

    A pharmaceutical aerosol foam composition including an effective amount of a pharmaceutically active ingredient; an occlusive agent; an aqueous solvent; and an organic cosolvent, the pharmaceutically active ingredient being insoluble in both water and the occlusive agent; the occlusive agent being present in an amount sufficient to form an occlusive layer on the skin, in use.

    Patent expiration dates:

    • September 8, 2019
      ✓ 
      Drug product
  • Penetrating pharmaceutical foam
    Patent 7,700,076
    Issued: April 20, 2010
    Inventor(s): Tamarkin; Dov & Friedman; Doron & Eini; Meir
    Assignee(s): Foamix, Ltd.

    The invention relates to an alcohol-free cosmetic or pharmaceutical foam composition comprising water, a hydrophobic solvent, a surface-active agent, a gelling agent, an active component selected from the group of urea, hydroxy acid and a therapeutic enhancer and a propellant. The foam further comprises active agents and excipients with therapeutic properties having enhanced skin penetration.

    Patent expiration dates:

    • September 18, 2027
      ✓ 
      Drug product
  • Penetrating pharmaceutical foam
    Patent 8,435,498
    Issued: May 7, 2013
    Assignee(s): Foamix Ltd.

    The invention relates to an alcohol-free cosmetic or pharmaceutical foam composition comprising water, a hydrophobic solvent, a surface-active agent, a gelling agent, an active component selected from the group of urea, hydroxy acid and a therapeutic enhancer and a propellant. The foam further comprises active agents and excipients with therapeutic properties having enhanced skin penetration.

    Patent expiration dates:

    • March 1, 2024
      ✓ 
      Patent use: TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA
  • Foamable carriers
    Patent 8,722,021
    Issued: May 13, 2014
    Assignee(s): Foamix Ltd.

    The invention relates to an alcohol-free cosmetic or therapeutic foam carrier comprising water, a hydrophobic organic carrier, a foam adjuvant agent, a surface-active agent and a gelling agent. The cosmetic or therapeutic foam carrier does not contain aliphatic alcohols, making it non-irritating and non-drying. The alcohol-free foam carrier is suitable for inclusion of both water-soluble and oil soluble therapeutic and cosmetic agents.

    Patent expiration dates:

    • October 24, 2023
      ✓ 
      Drug product
  • Foamable composition and uses thereof
    Patent 8,900,554
    Issued: December 2, 2014
    Assignee(s): Foamix Pharmaceuticals Ltd.

    The present invention provides a safe and effective insecticide composition suitable for treating a subject infested with a parasitic anthropode or to prevent infestation by an arthropod. The insecticide composition is a foamable composition, including a first insecticide; at least one organic carrier selected from a hydrophobic organic carrier, a polar solvent, an emollient and mixtures thereof, at a concentration of about 2% to about 5%, or about 5% to about 10%; or about 10% to about 20%; or about 20% to about 50% by weight; about 0.1% to about 5% by weight of a surface-active agent; about 0.01% to about 5% by weight of at least one polymeric agent selected from a bioadhesive agent, a gelling agent, a film forming agent and a phase change agent; and (5) a liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the total composition.

    Patent expiration dates:

    • October 24, 2023
      ✓ 
      Drug product
  • Antibiotic kit and composition and uses thereof
    Patent 9,211,259
    Issued: December 15, 2015
    Assignee(s): Foamix Pharmaceuticals Ltd.

    The present invention relates to a therapeutic kit to provide a safe and effective dosage of an antibiotic agent, including an aerosol packaging assembly including: a container accommodating a pressurized product; and an outlet capable of releasing the pressurized product as a foam, wherein the pressurized product comprises a foamable composition including: an antibiotic agent; at least one organic carrier selected from the group consisting of a hydrophobic organic carrier, an organic polar solvent, an emollient and mixtures thereof, at a concentration of about 2% to about 50% by weight, a surface-active agent, about 0.01% to about 5% by weight of at least one polymeric additive selected from the group consisting of a bioadhesive agent, a gelling agent, a film forming agent and a phase change agent, water; and liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the total composition.

    Patent expiration dates:

    • February 28, 2029
      ✓ 
      Patent use: TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA
  • Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
    Patent 9,265,725
    Issued: February 23, 2016
    Assignee(s): Foamix Pharmaceuticals Ltd.

    The present invention teaches a foamable pharmaceutical carrier comprising a benefit agent, selected from the group consisting of a dicarboxylic acid and a dicarboxylic acid ester; a stabilizer selected from the group consisting of at least one surface-active agent; at least one polymeric agent and mixtures thereof; a solvent selected from the group consisting of water, a hydrophilic solvent, a hydrophobic solvent, a potent solvent, a polar solvent, a silicone, an emollient, and mixtures thereof, wherein the benefit agent, stabilizer and solvent are selected to provide a composition that is substantially resistant to aging and to phase separation and or can substantially stabilize other active ingredients. The invention further relates to a foamable composition further containing a liquefied hydrocarbon gas propellant.

    Patent expiration dates:

    • December 8, 2027
      ✓ 
      Drug product

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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