Generic Ampyra Availability
AMPYRA (dalfampridine - tablet, extended release; oral)
Approval date: January 22, 2010
Strength(s): 10MG [RLD]
Has a generic version of Ampyra been approved?
No. There is currently no therapeutically equivalent version of Ampyra available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ampyra. 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.
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.
Formulations and their use in the treatment of neurological diseases
Issued: July 30, 1996
Inventor(s): Masterson; Joseph G. & Myers; Michael
Assignee(s): Elan Corporation, plc
Pharmaceutical formulations comprise a mono- or di-aminopyridine active agent for administration on a once- or twice-daily basis for use in the treatment of neurological diseases, in particular multiple sclerosis and Alzheimer's disease. The formulations, which are suitable for oral or percutaneous administration of the active agent, include the active agent in a carrier effective to permit release of the mono- or di-aminopyridine at a rate allowing controlled absorption thereof over, on the average, not less than a 12 hour period and at a rate sufficient to achieve therapeutically effective blood levels over a period of 12-24 hours following administration.Patent expiration dates:
- July 30, 2013✓
- July 30, 2013
Sustained release aminopyridine composition
Issued: August 30, 2011
Inventor(s): Blight; Andrew R. & Cohen; Ron
Assignee(s): Acorda Therapeutics, Inc.
A pharmaceutical composition which comprises a therapeutically effective amount of a aminopyridine dispersed in a release matrix, including, for example, a composition that can be formulated into a stable, sustained-release oral dosage formulation, such as a tablet which provides, upon administration to a patient, a therapeutically effective plasma level of the aminopyridine for a period of at least 12 hours, preferably 24 hours or more and the use of the composition to treat various neurological diseases.Patent expiration dates:
- May 26, 2027✓
- May 26, 2027
Method of using sustained release aminopyridine compositions
Issued: January 15, 2013
Assignee(s): Acorda Therapeutics, Inc.
A pharmaceutical composition which comprises a therapeutically effective amount of a aminopyridine dispersed in a release matrix, including, for example, a composition that can be formulated into a stable, sustained-release oral dosage formulation, such as a tablet which provides, upon administration to a patient, a therapeutically effective plasma level of the aminopyridine for a period of at about 12 hours and the use of the composition to treat various neurological diseases, including multiple sclerosis. A method of selecting individuals based on responsiveness to a treatment, including, for example, identifying individuals who responded to treatment with a sustained release fampridine composition.Patent expiration dates:
- December 22, 2026✓
- December 22, 2026
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 22, 2015 - NEW CHEMICAL ENTITY
- January 22, 2017 - ORPHAN DRUG EXCLUSIVITY
- Ampyra Consumer Information (Drugs.com)
- Ampyra Consumer Information (Wolters Kluwer)
- Ampyra Consumer Information (Cerner Multum)
- Ampyra Advanced Consumer Information (Micromedex)
- Ampyra AHFS DI Monographs (ASHP)
- Dalfampridine Consumer Information (Wolters Kluwer)
- Dalfampridine Consumer Information (Cerner Multum)
- Dalfampridine Advanced Consumer Information (Micromedex)
- Dalfampridine AHFS DI Monographs (ASHP)
|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.|