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Generic Rytary Availability

Rytary is a brand name of carbidopa/levodopa, approved by the FDA in the following formulation(s):

RYTARY (carbidopa; levodopa - capsule, extended release;oral)

  • Manufacturer: IMPAX LABS INC
    Approval date: January 7, 2015
    Strength(s): 23.75MG;95MG, 36.25MG;145MG, 48.75MG;195MG, 61.25MG;245MG [RLD]

Has a generic version of Rytary been approved?

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

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

  • Combination immediate release controlled release levodopa/carbidopa dosage forms
    Patent 7,094,427
    Issued: August 22, 2006
    Inventor(s): Han; Chien-Hsuan & Hsu; Larry & Hsu; Ann F.
    Assignee(s): Impax Laboratories, Inc.
    The present invention relates to dosage forms of a combination of carbidopa and levodopa comprising both immediate release and controlled release components for the treatment of ailments associated with depleted amounts of dopamine in a patient's brain tissue.
    Patent expiration dates:
    • May 29, 2022
      ✓ 
      Patent use: TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
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      Drug product
  • Controlled release formulations of levodopa and uses thereof
    Patent 8,377,474
    Issued: February 19, 2013
    Assignee(s): Impax Laboratories, Inc.
    The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.
    Patent expiration dates:
    • December 26, 2028
      ✓ 
      Patent use: TREATMENT OF PARKINSON'S DISEASE
      ✓ 
      Drug product
    • December 26, 2028
      ✓ 
      Patent use: TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
      ✓ 
      Drug product
  • Controlled release formulations of levodopa and uses thereof
    Patent 8,454,998
    Issued: June 4, 2013
    Assignee(s): Impax Laboratories, Inc.
    The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.
    Patent expiration dates:
    • December 26, 2028
      ✓ 
      Patent use: TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
      ✓ 
      Drug product
    • December 26, 2028
      ✓ 
      Patent use: TREATMENT OF PARKINSON'S DISEASE
      ✓ 
      Drug product
    • December 26, 2028
      ✓ 
      Patent use: TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
      ✓ 
      Drug product
    • December 26, 2028
      ✓ 
      Patent use: TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
      ✓ 
      Drug product
    • December 26, 2028
      ✓ 
      Patent use: TREATMENT OF POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
      ✓ 
      Drug product
  • Controlled release formulations of levodopa and uses thereof
    Patent 8,557,283
    Issued: October 15, 2013
    Assignee(s): Impax Laboratories, Inc.
    The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.
    Patent expiration dates:
    • December 26, 2028
      ✓ 
      Patent use: TREATMENT OF PARKINSON'S DISEASE
      ✓ 
      Drug product
    • December 26, 2028
      ✓ 
      Patent use: TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
      ✓ 
      Drug product
  • Controlled release formulations of levodopa and uses thereof
    Patent 9,089,607
    Issued: July 28, 2015
    Assignee(s): Impax Laboratories, Inc.
    The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.
    Patent expiration dates:
    • December 26, 2028
      ✓ 
      Patent use: TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
      ✓ 
      Drug product
    • December 26, 2028
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      Patent use: METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA
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      Drug product
  • Controlled release formulations of levodopa and uses thereof
    Patent 9,089,608
    Issued: July 28, 2015
    Assignee(s): Impax Laboratories, Inc.
    The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.
    Patent expiration dates:
    • December 26, 2028
      ✓ 
      Drug product
  • Controlled release formulations of levodopa and uses thereof
    Patent 9,463,246
    Issued: October 11, 2016
    Assignee(s): Impax Laboratories, Inc.
    The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.
    Patent expiration dates:
    • December 26, 2028
      ✓ 
      Patent use: TREATMENT OF PARKINSON'S DISEASE
      ✓ 
      Drug product

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:
    • January 7, 2018 - NEW DOSAGE FORM

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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