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)
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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.
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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 LimitedInvented 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✓✓✓
- November 20, 2022✓✓✓
- November 20, 2022✓✓✓
- November 20, 2022✓✓✓
- November 20, 2022✓✓✓
- May 20, 2023✓
- November 20, 2022
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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✓✓✓
- July 13, 2025✓✓✓
- July 13, 2025✓✓✓
- July 13, 2025✓✓✓
- July 13, 2025✓✓✓
- January 13, 2026✓
- July 13, 2025
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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 LLCAn 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✓
- May 21, 2023✓
- May 21, 2023✓
- May 21, 2023✓
- November 21, 2023✓
- May 21, 2023
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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 LLCDisclosed 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✓✓
- August 1, 2027✓✓
- August 1, 2027✓✓
- August 1, 2027✓✓
- August 1, 2027✓✓
- February 1, 2028✓
- August 1, 2027
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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 LLCDisclosed 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✓✓
- August 1, 2027✓✓
- August 1, 2027✓✓
- August 1, 2027✓✓
- February 1, 2028✓
- August 1, 2027
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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 LLCDisclosed 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✓✓
- August 1, 2027✓✓
- August 1, 2027✓✓
- August 1, 2027✓✓
- February 1, 2028✓
- August 1, 2027
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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 LLCDisclosed 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✓✓
- August 1, 2027✓✓
- August 1, 2027✓✓
- August 1, 2027✓✓
- February 1, 2028✓
- August 1, 2027
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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 LLCDisclosed 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✓✓
- August 1, 2027✓✓
- February 1, 2028✓
- August 1, 2027
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
More about Promacta (eltrombopag)
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- Drug class: platelet-stimulating agents
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Glossary
Term | Definition |
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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.