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Generic Promacta Availability

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

PROMACTA (eltrombopag olamine - for suspension;oral)

  • Manufacturer: NOVARTIS PHARMS CORP
    Approval date: August 24, 2015
    Strength(s): EQ 25MG ACID/PACKET [RLD]

PROMACTA (eltrombopag olamine - tablet;oral)

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

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.

  • Metal complexes
    Patent 6,280,959
    Issued: August 28, 2001
    Inventor(s): Gleason; John G. & Luengo; Juan I.
    Assignee(s): SmithKline Beecham Corporation
    The invention describes zinc chelated dimeric cell-surface receptor ligands, pharmaceutical compositions containing these compounds, methods of using these compounds as agonist of dimeric cell-surface receptors. Novel processes used in preparing the compounds are also described. Further, the invention describes novel receptor binding moieties of the zinc chelated cell-surface receptor ligands.
    Patent expiration dates:
    • October 30, 2018
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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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    • October 30, 2018
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    • October 30, 2018
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    • October 30, 2018
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    • October 30, 2018
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    • April 30, 2019
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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 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 IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
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    • November 20, 2022
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    • November 20, 2022
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    • November 20, 2022
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    • November 20, 2022
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    • May 20, 2023
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  • Thrombopoietin mimetics
    Patent 7,332,481
    Issued: February 19, 2008
    Inventor(s): Duffy; Kevin J. & Erickson-Miller; Connie & Jenkins; Julian & Luengo; Juan & Price; Alan T. & Shaw; Antony N. & Visonneau; Sophie & Wiggall; Kenneth
    Assignee(s): SmithKline Beecham Corporation
    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:
    • May 24, 2021
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      Patent use: TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
    • May 24, 2021
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    • May 24, 2021
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    • May 24, 2021
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    • May 24, 2021
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    • November 24, 2021
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  • Thrombopoietin mimetics
    Patent 7,452,874
    Issued: November 18, 2008
    Inventor(s): Duffy; Kevin J. & Luengo; Juan I. & Shaw; Antony N. & Wiggall; Kenneth
    Assignee(s): SmithKline Beecham Corp.
    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:
    • May 24, 2021
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      Patent use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
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    • May 24, 2021
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    • November 24, 2021
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  • Thrombopoietin mimetics
    Patent 7,473,686
    Issued: January 6, 2009
    Inventor(s): Duffy; Kevin J. & Erickson-Miller; Connie & Jenkins; Julian & Luengo; Juan I. & Visonneau; Sophie
    Assignee(s): SmithKline Beecham Corp.
    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:
    • May 24, 2021
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    • May 24, 2021
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    • May 24, 2021
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    • May 24, 2021
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    • May 24, 2021
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    • November 24, 2021
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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
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    • July 13, 2025
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    • July 13, 2025
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    • July 13, 2025
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    • January 13, 2026
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  • Thrombopoietin mimetics
    Patent 7,790,704
    Issued: September 7, 2010
    Inventor(s): Duffy; Kevin J. & Erickson-Miller; Connie & Jenkins; Julian & Luengo; Juan I.
    Assignee(s): GlaxoSmithKline, LLC
    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:
    • May 24, 2021
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      Patent use: PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
    • May 24, 2021
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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 24, 2021
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      Patent use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
    • May 24, 2021
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    • May 24, 2021
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    • November 24, 2021
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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 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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    • May 21, 2023
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    • May 21, 2023
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    • May 21, 2023
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    • November 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 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
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    • August 1, 2027
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    • August 1, 2027
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    • August 1, 2027
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    • February 1, 2028
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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 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
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      Patent use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
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    • August 1, 2027
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    • August 1, 2027
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    • February 1, 2028
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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 8,052,995
    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
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    • August 1, 2027
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    • February 1, 2028
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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 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
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    • August 1, 2027
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    • August 1, 2027
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    • August 1, 2027
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    • August 1, 2027
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    • February 1, 2028
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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 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
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    • August 1, 2027
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    • August 1, 2027
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    • August 1, 2027
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    • February 1, 2028
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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 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
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      Patent use: TREATMENT OF IMMUNE (IDIOPATIC) THROMBOCYTOPENIA (ITP)
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    • August 1, 2027
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    • August 1, 2027
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    • February 1, 2028
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      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:
    • November 16, 2015 - TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
    • November 20, 2015 - ORPHAN DRUG EXCLUSIVITY
    • June 11, 2018 - INCLUSION OF PEDIATRIC PATIENTS AGES 6 YRS AND OLDER FOR THE TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC ITP WHO HAVE HAD AN INSUFFICIENT RESPONSE TO CORTICOSTEROIDS, IMMUNOGLOBULINS, OR SPLENECTOMY.
    • June 11, 2018 - DOSING INFORMATION ADDED TO THE LABELING REGARDING PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH ITP
    • December 11, 2018 - PEDIATRIC EXCLUSIVITY
    • August 26, 2021 - ORPHAN DRUG EXCLUSIVITY
    • February 26, 2022 - PEDIATRIC EXCLUSIVITY

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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