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Generic Promacta Availability

Last updated on Jan 11, 2023.

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

PROMACTA (eltrombopag olamine - tablet;oral)

  • Manufacturer: NOVARTIS
    Approval date: November 20, 2008
    Strength(s): EQ 25MG ACID [RLD], EQ 50MG ACID [RLD]
  • Manufacturer: NOVARTIS
    Approval date: September 8, 2009
    Strength(s): EQ 75MG ACID [RLD]
  • Manufacturer: NOVARTIS
    Approval date: October 20, 2011
    Strength(s): EQ 12.5MG ACID [RLD]
  • Manufacturer: NOVARTIS
    Approval date: November 16, 2012
    Strength(s): EQ 100MG ACID (discontinued) [RLD]

Has a generic version of Promacta been approved?

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

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

  • Thrombopoietin mimetics
    Patent 7,160,870
    Issued: January 9, 2007
    Inventor(s): Duffy; Kevin J. & Erickson-Miller; Connie & Jenkins; Julian & Luengo; Juan I. & Visonneau; Sophie
    Assignee(s): SmithKline Beecham Corporation Glaxo Group Limited

    Invented are non-peptide TPO mimetics. Also invented are novel processes and intermediates used in the preparation of the presently invented compounds. Also invented is a method of treating thrombocytopenia, in a mammal, including a human, in need thereof which comprises administering to such mammal an effective amount of a selected hydroxy-1-azobenzene derivative.

    Patent expiration dates:

    • November 20, 2022
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      Patent use: TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
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      Drug substance
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    • November 20, 2022
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      Patent use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
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    • November 20, 2022
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      Patent use: TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
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      Drug substance
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      Drug product
    • November 20, 2022
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
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    • November 20, 2022
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      Patent use: PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
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      Drug substance
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      Drug product
    • May 20, 2023
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      Pediatric exclusivity
  • 3′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine)
    Patent 7,547,719
    Issued: June 16, 2009
    Inventor(s): Moore; Stephen
    Assignee(s): SmithKline Beecham Corp.

    An improved thrombopoietin mimetic, the bis-(monoethanolamine) salt of 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid.

    Patent expiration dates:

    • July 13, 2025
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
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    • July 13, 2025
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      Patent use: PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
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    • July 13, 2025
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      Patent use: COMBINATION WITH IMMUNOSUPPRESSIVE THERAPY FOR FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
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    • July 13, 2025
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      Patent use: TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
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    • July 13, 2025
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      Patent use: TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
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      Drug substance
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      Drug product
    • January 13, 2026
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      Pediatric exclusivity
  • 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
    Patent 7,795,293
    Issued: September 14, 2010
    Inventor(s): Moore; Stephen
    Assignee(s): GlaxoSmithKline LLC

    An improved thrombopoietin mimetic, the bis-(monoethanolamine) salt of 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid.

    Patent expiration dates:

    • May 21, 2023
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      Patent use: TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
    • May 21, 2023
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      Patent use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
    • May 21, 2023
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      Patent use: TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
    • May 21, 2023
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      Patent use: PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
    • November 21, 2023
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      Pediatric exclusivity
  • 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
    Patent 8,052,993
    Issued: November 8, 2011
    Inventor(s): Muller; Francis X & Kapsi; Shivakumar G
    Assignee(s): GlaxoSmithKline LLC

    Disclosed are novel pharmaceutical compositions containing 3′-[(2Z)-[1-(3,4-dimethylphenyl) -1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine) (eltrombopag olamine) and processes for preparing the same.

    Patent expiration dates:

    • August 1, 2027
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
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      Drug product
    • August 1, 2027
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      Patent use: TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
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      Drug product
    • August 1, 2027
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
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      Drug product
    • August 1, 2027
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      Patent use: TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
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      Drug product
    • August 1, 2027
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      Patent use: PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
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      Drug product
    • February 1, 2028
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      Pediatric exclusivity
  • 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene] hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
    Patent 8,052,994
    Issued: November 8, 2011
    Inventor(s): Muller; Francis X. & Kapsi; Shivakumar G.
    Assignee(s): GlaxoSmithKline LLC

    Disclosed are novel pharmaceutical compositions containing 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine) (eltrombopag olamine) and processes for preparing the same.

    Patent expiration dates:

    • August 1, 2027
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
      ✓ 
      Drug product
    • August 1, 2027
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
      ✓ 
      Drug product
    • August 1, 2027
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
      ✓ 
      Drug product
    • August 1, 2027
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      Patent use: TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
      ✓ 
      Drug product
    • February 1, 2028
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      Pediatric exclusivity
  • 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
    Patent 8,062,665
    Issued: November 22, 2011
    Inventor(s): Muller; Francis X & Kapsi; Shivakumar G
    Assignee(s): GlaxoSmithKline LLC

    Disclosed are novel pharmaceutical compositions containing 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine) (eltrombopag olamine) and processes for preparing the same.

    Patent expiration dates:

    • August 1, 2027
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
      ✓ 
      Drug product
    • August 1, 2027
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
      ✓ 
      Drug product
    • August 1, 2027
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
      ✓ 
      Drug product
    • August 1, 2027
      ✓ 
      Patent use: TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
      ✓ 
      Drug product
    • February 1, 2028
      ✓ 
      Pediatric exclusivity
  • 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
    Patent 8,071,129
    Issued: December 6, 2011
    Inventor(s): Muller; Francis X & Kapsi; Shivakumar G
    Assignee(s): GlaxoSmithKline LLC

    Disclosed are novel pharmaceutical compositions containing 3′-[(2Z)-[1-(3,4-dimethylphenyl) -1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine) (eltrombopag olamine) and processes for preparing the same.

    Patent expiration dates:

    • August 1, 2027
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
      ✓ 
      Drug product
    • August 1, 2027
      ✓ 
      Patent use: TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
      ✓ 
      Drug product
    • August 1, 2027
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
      ✓ 
      Drug product
    • August 1, 2027
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
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      Drug product
    • February 1, 2028
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      Pediatric exclusivity
  • 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
    Patent 8,828,430
    Issued: September 9, 2014
    Assignee(s): GlaxoSmithKline LLC

    Disclosed are novel pharmaceutical compositions containing 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis (monoethanolamine) (eltrombopag olamine) and processes for preparing the same.

    Patent expiration dates:

    • August 1, 2027
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
      ✓ 
      Drug product
    • August 1, 2027
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
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      Drug product
    • February 1, 2028
      ✓ 
      Pediatric exclusivity

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:

    • February 26, 2022 - PEDIATRIC EXCLUSIVITY
    • November 16, 2025 - INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA

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.

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