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Generic Otezla Availability

Last updated on Oct 6, 2021.

Otezla is a brand name of apremilast, approved by the FDA in the following formulation(s):

OTEZLA (apremilast - tablet;oral)

  • Manufacturer: AMGEN INC
    Approval date: March 21, 2014
    Strength(s): 10MG [RLD] [AB], 20MG [RLD] [AB], 30MG [RLD] [AB]

Has a generic version of Otezla been approved?

A generic version of Otezla 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 Otezla and have been approved by the FDA:

apremilast tablet;oral

  • Manufacturer: ALKEM LABS LTD
    Approval date: September 21, 2021
    Strength(s): 10MG [AB], 20MG [AB], 30MG [AB]
  • Manufacturer: AMNEAL
    Approval date: June 30, 2021
    Strength(s): 10MG [AB], 20MG [AB], 30MG [AB]
  • Manufacturer: ZYDUS PHARMS
    Approval date: September 21, 2021
    Strength(s): 10MG [AB], 20MG [AB], 30MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Otezla. 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 FAQ.

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.

  • Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast
    Patent 10,092,541
    Issued: October 9, 2018
    Assignee(s): Celgene Corporation

    Methods of treating, managing or preventing diseases ameliorated by inhibiting PDE4 such as psoriasis, ankylosing spondylitis, Behcet's disease, rheumatoid arthritis, atopic dermatitis, Crohn's disease, and ulcerative colitis are disclosed. Specific methods encompass the administration of apremilast in specific dosage titration schedule, alone or in combination with a second active agent.

    Patent expiration dates:

    • May 29, 2034
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      Patent use: TREATMENT OF PSORIASIS USING A DOSAGE TITRATION SCHEDULE
    • May 29, 2034
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE USING A DOSAGE TITRATION SCHEDULE
  • (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione: methods of using and compositions thereof
    Patent 6,962,940
    Issued: November 8, 2005
    Inventor(s): Muller; George W. & Schafer; Peter H. & Man; Hon-Wah & Ge; Chuansheng
    Assignee(s): Celgene Corporation

    Stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, substantially free of its (−) isomer, and prodrugs, metabolites, polymorphs, salts, solvates, hydrates, and clathrates thereof are discussed. Also discussed are methods of using and pharmaceutical compositions comprising the (+) enantiomer of 2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-α or the inhibition of PDE4.

    Patent expiration dates:

    • March 19, 2023
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
    • March 19, 2023
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
    • March 19, 2023
      ✓ 
      Patent use: TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
    • March 19, 2023
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      Patent use: USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4
  • Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione
    Patent 7,208,516
    Issued: April 24, 2007
    Inventor(s): Muller; George W. & Schafer; Peter H. & Rohane; Patricia E. W.
    Assignee(s): Celgene Corporation

    Methods of treating, managing or preventing psoriatic arthritis are disclosed. Specific methods encompass the administration of (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione alone or in combination with a second active agent. Pharmaceutical compositions and single unit dosage forms are also disclosed.

    Patent expiration dates:

    • March 19, 2023
      ✓ 
      Patent use: USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
  • (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof
    Patent 7,427,638
    Issued: September 23, 2008
    Inventor(s): Muller; George W. & Schafer; Peter H. & Man; Hon-Wah & Ge; Chuansheng
    Assignee(s): Celgene Corporation

    Stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, substantially free of its (−) isomer, and prodrugs, metabolites, polymorphs, salts, solvates, hydrates, and clathrates thereof are discussed. Also discussed are methods of using and pharmaceutical compositions comprising the (+) enantiomer of 2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-α or the inhibition of PDE4.

    Patent expiration dates:

    • February 16, 2028
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      Drug substance
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      Drug product
  • Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione
    Patent 7,659,302
    Issued: February 9, 2010
    Inventor(s): Muller; George W. & Schafer; Peter H. & Man; Hon-Wah & Ge; Chuansheng
    Assignee(s): Celgene Corporation

    Stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, substantially free of its (−) isomer, and prodrugs, metabolites, polymorphs, salts, solvates, hydrates, and clathrates thereof are discussed. Also discussed are methods of using and pharmaceutical compositions comprising the (+) enantiomer of 2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-α or the inhibition of PDE4.

    Patent expiration dates:

    • March 19, 2023
      ✓ 
      Patent use: USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
    • March 19, 2023
      ✓ 
      Patent use: USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
    • March 19, 2023
      ✓ 
      Patent use: TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
    • March 19, 2023
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
  • Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof
    Patent 7,893,101
    Issued: February 22, 2011
    Inventor(s): Muller; George W. & Schafer; Peter H. & Man; Hon-Wah & Ge; Chuansheng & Xu; Jean
    Assignee(s): Celgene Corporation

    Solid forms comprising (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions comprising the solid forms, methods of making the solid forms and methods of their use are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-α or the inhibition of PDE4.

    Patent expiration dates:

    • December 9, 2023
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione
    Patent 8,455,536
    Issued: June 4, 2013
    Assignee(s): Celgene Corporation

    Stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, substantially free of its (−) isomer, and prodrugs, metabolites, polymorphs, salts, solvates, hydrates, and clathrates thereof are discussed. Also discussed are methods of using and pharmaceutical compositions comprising the (+) enantiomer of 2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-α or the inhibition of PDE4.

    Patent expiration dates:

    • March 19, 2023
      ✓ 
      Patent use: USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
    • March 19, 2023
      ✓ 
      Patent use: TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
    • March 19, 2023
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
    • March 19, 2023
      ✓ 
      Patent use: USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
  • Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione
    Patent 8,802,717
    Issued: August 12, 2014
    Assignee(s): Celgene Corporation

    Stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, substantially free of its (−) isomer, and prodrugs, metabolites, polymorphs, salts, solvates, hydrates, and clathrates thereof are discussed. Also discussed are methods of using and pharmaceutical compositions comprising the (+) enantiomer of 2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-α or the inhibition of PDE4.

    Patent expiration dates:

    • March 19, 2023
      ✓ 
      Patent use: USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
  • Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof
    Patent 9,018,243
    Issued: April 28, 2015
    Assignee(s): Celgene Corporation

    Solid forms comprising (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions comprising the solid forms, methods of making the solid forms and methods of their use are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-α or the inhibition of PDE4.

    Patent expiration dates:

    • March 19, 2023
      ✓ 
      Patent use: USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
    • March 19, 2023
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
    • March 19, 2023
      ✓ 
      Patent use: TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
    • March 19, 2023
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
    • March 19, 2023
      ✓ 
      Patent use: USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
  • Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione
    Patent 9,724,330
    Issued: August 8, 2017
    Assignee(s): Celgene Corporation

    Stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, substantially free of its (−) isomer, and prodrugs, metabolites, polymorphs, salts, solvates, hydrates, and clathrates thereof are discussed. Also discussed are methods of using and pharmaceutical compositions comprising the (+) enantiomer of 2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-α or the inhibition of PDE4.

    Patent expiration dates:

    • March 19, 2023
      ✓ 
      Patent use: USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
    • March 19, 2023
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
    • March 19, 2023
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
    • March 19, 2023
      ✓ 
      Patent use: TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
    • March 19, 2023
      ✓ 
      Patent use: USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
  • Methods for the treatment of psoriatic arthritis using apremilast
    Patent 9,872,854
    Issued: January 23, 2018
    Assignee(s): Celgene Corporation

    Methods of treating, managing or preventing psoriatic arthritis are disclosed. Specific methods encompass the administration of apremilast, alone or in combination with a second active agent.

    Patent expiration dates:

    • May 29, 2034
      ✓ 
      Patent use: TREATMENT OF PSORIATIC ARTHRITIS USING A DOSAGE TITRATION SCHEDULE
    • May 29, 2034
      ✓ 
      Patent use: TREATMENT OF PSORIATIC ARTHRITIS WITH APREMILAST USING A DOSAGE TITRATION SCHEDULE AND A SECOND ACTIVE AGENT

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • July 19, 2022 - TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
    • April 10, 2023 - INFORMATION ADDED TO THE CLINICAL STUDIES SECTION OF THE LABELING REGARDING THE USE OF PLAQUE PSORIASIS OF THE SCALP
    • July 19, 2026 -

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 (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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.

Further information

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