Generic Rytary Availability

Last updated on Sep 11, 2024.

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
Approval date: January 7, 2015
Strength(s): 23.75MG;95MG ^[RLD], 36.25MG;145MG ^[RLD], 48.75MG;195MG ^[RLD], 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.

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.

Controlled release formulations of levodopa and uses thereof
Patent 8,377,474
Issued: February 19, 2013
Inventor(s): Hsu Ann & Kou Jim H. & Alani Laman
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
Inventor(s): Hsu Ann & Kou Jim H. & Alani Laman
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 POST-ENCEPHALITIC PARKINSONISM
  ✓
  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
- 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 PARKINSON'S DISEASE
  ✓
  Drug product
Controlled release formulations of levodopa and uses thereof
Patent 8,557,283
Issued: October 15, 2013
Inventor(s): Hsu Ann & Kou Jim H. & Alani Laman Lynn
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
Inventor(s): Hsu Ann & Kou Jim H. & Alani Laman Lynn
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: METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA
  ✓
  Drug product
Controlled release formulations of levodopa and uses thereof
Patent 9,089,608
Issued: July 28, 2015
Inventor(s): Hsu Ann & Kou Jim H. & Alani Laman Lynn
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
Inventor(s): Hsu Ann & Kou Jim H. & Alani Laman Lynn
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
Controlled release formulations of levodopa and uses thereof
Patent 9,533,046
Issued: January 3, 2017
Inventor(s): Hsu Ann & Kou Jim & Alani Laman
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
Controlled release formulations of levodopa and uses thereof
Patent 9,901,640
Issued: February 27, 2018
Inventor(s): Hsu Ann & Kou Jim & Alani Laman
Assignee(s): Impax Laboratories, Inc.
A modified release levodopa dosage form.
Patent expiration dates:
- December 26, 2028
  ✓
  Patent use: TREATMENT OF PARKINSON'S DISEASE
  ✓
  Drug product

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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.

Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

User Reviews & Ratings

6.0 / 10

28 Reviews