Generic Stalevo 200 Availability

See also: Generic Stalevo 100, Generic Stalevo 125, Generic Stalevo 150, Generic Stalevo 50, Generic Stalevo 75

Stalevo 200 is a brand name of carbidopa/entacapone/levodopa, approved by the FDA in the following formulation(s):

STALEVO 200 (carbidopa; entacapone; levodopa - tablet;oral)

  • Manufacturer: ORION PHARMA
    Approval date: August 2, 2007
    Strength(s): 50MG;200MG;200MG [RLD] [AB]

Has a generic version of Stalevo 200 been approved?

A generic version of Stalevo 200 has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Stalevo 200 and have been approved by the FDA:

CARBIDOPA, LEVODOPA AND ENTACAPONE (carbidopa; entacapone; levodopa tablet;oral)

  • Manufacturer: WOCKHARDT LTD
    Approval date: November 20, 2012
    Strength(s): 50MG;200MG;200MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Stalevo 200. 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.

  • Pharmacologically active catechol derivatives
    Patent 5,446,194
    Issued: August 29, 1995
    Inventor(s): Backstrom; Reijo J. & Heinola; Kalevi E. & Honkanen; Erkki J. & Kaakkola; Seppo K. & Kairisalo; Pekka J. & Linden; Inge-Britt Y. & Mannisto; Pekka I. & Nissinen; Erkki A. O. & Pohto; Pentti & Pippuri; Aino K. & Pystynen; Jarmo J.
    Assignee(s): Orion-yhtyma Oy
    A compound according to formula 1 ##STR1## wherein R.sub.1 and R.sub.2 independently represent hydrogen, carbamoyl which is substituted by an alkyl of 1 to 4 carbon atoms, alkylcarbonyl of 2 to 5 carbon atoms or phenyl carbonyl, X represents halogen nitro or cyano and R.sub.3 represents ##STR2## wherein R.sub.4 represents cyano or alkylcarbonyl of 2 to 5 carbon atoms and R.sub.5 represents carbamoyl which is unsubstituted or substituted with alkyl of 1 to 8 carbon atoms or which is substituted with hydroxyalkyl of 1 to 8 carbon atoms or pharmaceutically acceptable esters and salts thereof, and a pharmaceutically acceptable carrier therefor, as well as pharmaceutical compositions containing said compounds as COMT inhibitors.
    Patent expiration dates:
    • October 19, 2013
      ✓ 
      Drug substance
  • Pharmaceutical composition comprising entacapone, levodopa, and carbidopa
    Patent 6,500,867
    Issued: December 31, 2002
    Inventor(s): Matti; Virkki & Kari; Vahervuo & Marja; Ritala & Marja; Partanen & Mervi; Niskanen & Jarmo; Lintulaakso & Marja; Laaksonen & Lasse; Kervinen & Sari; Kallioinen
    Assignee(s): Orion Corporation
    An oral solid fixed dose composition comprising pharmacologically effective amounts of entacapone, levodopa, and carbidopa, or pharmaceutically acceptable salts or hydrates thereof, and comprising at least one pharmaceutically acceptable excipient. The composition can be used, e.g., for the treatment of Parkinson's disease.
    Patent expiration dates:
    • June 29, 2020
      ✓ 
      Patent use: TREATMENT OF PARKINSON'S DISEASE
      ✓ 
      Drug product
  • Pharmaceutical composition comprising entracapone, levodopa, and carbidopa
    Patent 6,797,732
    Issued: September 28, 2004
    Inventor(s): Matti; Virkki & Kari; Vahervuo & Marja; Ritala & Marja; Partanen & Mervi; Niskanen & Jarmo; Lintulaakso & Marja; Laaksonen & Lasse; Kervinen & Sari; Kallioinen
    Assignee(s): Orion Corporation
    An oral solid fixed dose composition comprising pharmacologically effective amounts of entacapone, levodopa, and carbidopa, or pharmaceutically acceptable salts or hydrates thereof, and comprising at least one pharmaceutically acceptable excipient. The composition can be used, e.g., for the treatment of Parkinson's disease.
    Patent expiration dates:
    • June 29, 2020
      ✓ 
      Drug product

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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
Hide
(web5)