Generic Otezla Availability
Last updated on Oct 7, 2026.
Otezla (see also: Generic Otezla XR) is a brand name of apremilast, approved by the FDA in the following formulations:
| Manufacturer | Approval date | Strengths [RLD] [AB] |
|---|---|---|
| AMGEN INC | March 21, 2014 |
|
Has a generic version of Otezla been approved?
Yes, the FDA has approved a generic version of Otezla. However, FDA approval doesn't guarantee the generic will be available in pharmacies. Drug patents or exclusivity rights that are still active can legally prevent manufacturers from selling the generic even after FDA approval.
| Manufacturer | Approval date | Strengths [AB] |
|---|---|---|
| ALKEM LABS LTD | September 21, 2021 |
|
| SHILPA | April 7, 2023 |
|
| ANNORA | July 26, 2023 |
|
| MANKIND PHARMA | February 7, 2024 |
|
| MSN | December 16, 2024 |
|
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.
Generic Otezla prices
Pricing information is not currently available. While the medication may be approved, it does not appear to be commercially available at this time. Market launch delays can occur. For the most accurate and up-to-date information, consider contacting the manufacturer.
Patent protection
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development. These patents may include claims related to the drug's formulation, manufacturing process, or other aspects.
| Patent Title | Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast |
|---|---|
| Patent Number | 10,092,541 |
| Issue Date | October 9, 2018 |
| Inventor | Day Robert |
| Current Assignee | Celgene Corporation |
| Patent Description |
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 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 Expiry Dates |
|
| Patent Title | Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast |
|---|---|
| Patent Number | 10092541*PE |
| Issue Date | October 9, 2018 |
| Inventor | Day Robert |
| Current Assignee | Celgene Corporation |
| Patent Description |
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 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 Expiry Dates |
November 29, 2034
|
| Patent Title | Formulations of (+)-2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-4-acetylaminoisoindoline-1,3-dione |
|---|---|
| Patent Number | 12,576,034 |
| Issue Date | March 17, 2026 |
| Inventor | Bhat; Sreenivas S. et al. |
| Current Assignee | AMGEN INC. (Thousand Oaks, CA) |
| Patent Description |
Pharmaceutical compositions and single unit dosage forms of (+)-2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-4-acetylaminoisoindoline-1,3-dione, or a pharmaceutically acceptable stereoisomer, prodrug, salt, solvate, hydrate, or...
Pharmaceutical compositions and single unit dosage forms of (+)-2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-4-acetylaminoisoindoline-1,3-dione, or a pharmaceutically acceptable stereoisomer, prodrug, salt, solvate, hydrate, or clathrate thereof, are provided herein. Also provided are methods of treating, managing, or preventing various diseases or disorders.
|
| Patent Expiry Dates |
|
| Patent Title | Formulations of (+)-2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-4-acetylaminoisoindoline-1,3-dione |
|---|---|
| Patent Number | 12576034*PE |
| Issue Date | March 17, 2026 |
| Inventor | Bhat; Sreenivas S. et al. |
| Current Assignee | AMGEN INC. (Thousand Oaks, CA) |
| Patent Description |
Pharmaceutical compositions and single unit dosage forms of (+)-2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-4-acetylaminoisoindoline-1,3-dione, or a pharmaceutically acceptable stereoisomer, prodrug, salt, solvate, hydrate, or...
Pharmaceutical compositions and single unit dosage forms of (+)-2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-4-acetylaminoisoindoline-1,3-dione, or a pharmaceutically acceptable stereoisomer, prodrug, salt, solvate, hydrate, or clathrate thereof, are provided herein. Also provided are methods of treating, managing, or preventing various diseases or disorders.
|
| Patent Expiry Dates |
May 30, 2034
|
| Patent Title | (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof |
|---|---|
| Patent Number | 7,427,638 |
| Issue Date | September 23, 2008 |
| Inventor | Muller; George W. & Schafer; Peter H. & Man; Hon-Wah & Ge; Chuansheng |
| Current Assignee | Celgene Corporation (Summit, NJ) |
| Patent Description |
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...
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 Expiry Dates |
February 16, 2028
Drug Substance: Yes Drug Product: Yes |
| Patent Title | (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof |
|---|---|
| Patent Number | 7427638*PED |
| Issue Date | September 23, 2008 |
| Inventor | Muller; George W. & Schafer; Peter H. & Man; Hon-Wah & Ge; Chuansheng |
| Current Assignee | Celgene Corporation (Summit, NJ) |
| Patent Description |
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...
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 Expiry Dates |
August 16, 2028
|
| Patent Title | Methods for the treatment of psoriatic arthritis using apremilast |
|---|---|
| Patent Number | 9,872,854 |
| Issue Date | January 23, 2018 |
| Inventor | Day Robert |
| Current Assignee | Celgene Corporation |
| Patent Description |
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 Expiry Dates |
|
| Patent Title | Methods for the treatment of psoriatic arthritis using apremilast |
|---|---|
| Patent Number | 9872854*PED |
| Issue Date | January 23, 2018 |
| Inventor | Day Robert |
| Current Assignee | Celgene Corporation |
| Patent Description |
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 Expiry Dates |
November 29, 2034
|
FDA exclusivity
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.
| Expiration Date | Description |
|---|---|
| July 19, 2026 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE |
| July 20, 2026 | CLINICAL STUDY INFORMATION ADDED TO THE LABEL ABOUT THE TREATMENT OF MODERATE TO SEVERE GENITAL PSORIASIS |
| January 19, 2027 | PEDIATRIC EXCLUSIVITY |
| January 20, 2027 | PEDIATRIC EXCLUSIVITY |
| April 25, 2027 | NEW PATIENT POPULATION |
| October 25, 2027 | PEDIATRIC EXCLUSIVITY |
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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.
