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Generic Seysara Availability

Medically reviewed by Drugs.com. Last updated on May 11, 2021.

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

SEYSARA (sarecycline hydrochloride - tablet;oral)

  • Manufacturer: ALMIRALL
    Approval date: October 1, 2018
    Strength(s): EQ 60MG BASE [RLD], EQ 100MG BASE [RLD], EQ 150MG BASE [RLD]

Has a generic version of Seysara been approved?

No. There is currently no therapeutically equivalent version of Seysara available in the United States.

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

  • Substituted tetracycline compounds
    Patent 8,318,706
    Issued: November 27, 2012
    Inventor(s): Kim; Oak & Assefa; Haregewein & Honeyman; Laura
    Assignee(s): Paratek Pharmaceuticals, Inc.

    The present invention pertains, at least in part, to novel substituted tetracycline compounds. These tetracycline compounds can be used to treat numerous tetracycline compound-responsive states, such as bacterial infections and neoplasms.

    Patent expiration dates:

    • May 1, 2031
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      Patent use: A METHOD FOR TREATING A BACTERIAL INFECTION IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE
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  • Substituted tetracycline compounds for treatment of inflammatory skin disorders
    Patent 8,513,223
    Issued: August 20, 2013
    Assignee(s): Paratek Pharmaceuticals, Inc.

    Methods and compositions for the treatment of skin disorders (e.g., acne, rosacea) are described.

    Patent expiration dates:

    • December 7, 2029
      ✓ 
      Patent use: A METHOD FOR TREATING A PATIENT 9 YEARS OF AGE AND OLDER SUFFERING FROM AN INFLAMMATORY SKIN DISORDER OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE
  • Crystalline salts of (4S,4AS,5AR,12AS)-4-dimethylamino-3,10,12,12A-tetrahydroxy-7-[methoxy(methyl)amino)-methyl] acid amide and methods of using the same
    Patent 9,255,068
    Issued: February 9, 2016
    Assignee(s): Warner Chilcott Company, LLC Paratek Pharmaceuticals, Inc.

    A crystalline mono hydrochloride salt of (4S,4aS,5aR,12aS)-4-dimethylamino-3,10,12,12a-tetrahydroxy-7-[(methoxy(methyl)amino)-methyl]-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydro-naphthacene-2-carboxylic acid amide is disclosed having improved stability. In addition, a crystalline mono mesylate salt and crystalline mono sulfate salt of (4S,4aS,5aR,12aS)-4-dimethylamino-3,10,12,12a-tetrahydroxy-7-[(methoxy(methyl)amino)-methyl]-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydro-naphthacene-2-carboxylic acid amide are also disclosed having improved stability. A pharmaceutical composition containing the crystalline salts and methods of treating inflammatory skin disorders and bacterial infections comprising administering the crystalline salts are also disclosed.

    Patent expiration dates:

    • February 9, 2033
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      Patent use: A METHOD FOR TREATING ACNE IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE CRYSTALLINE SALT
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    • February 9, 2033
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      Patent use: A METHOD FOR TREATING A BACTERIAL INFECTION IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE CRYSTALLINE SALT
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      Drug substance
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  • Substituted tetracycline compounds for treatment of inflammatory skin disorders
    Patent 9,481,639
    Issued: November 1, 2016
    Assignee(s): Paratek Pharmaceuticals, Inc.

    Methods and compositions for the treatment of skin disorders (e.g., acne, rosacea) are described.

    Patent expiration dates:

    • August 10, 2028
      ✓ 
      Patent use: A METHOD FOR TREATING ACNE IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING SARECYCLINE HYDROCHLORIDE IN 60 MG, 100 MG OR 150 MG EQUIVALENT DOSES

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:

    • October 1, 2023 - NEW CHEMICAL ENTITY

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.

Further information

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