Thursday, September 15, 2016

Ampyra


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


AMPYRA (dalfampridine - tablet, extended release; oral)



  • Manufacturer: ACORDA

    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.




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.




  • Formulations and their use in the treatment of neurological diseases
    Patent 5,370,879
    Issued: December 6, 1994
    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:

    • December 6, 2011
      ✓ 
      Drug product




  • Formulations and their use in the treatment of neurological diseases
    Patent 5,540,938
    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
      ✓ 
      Patent use: IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)




  • Sustained release aminopyridine composition
    Patent 8,007,826
    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
      ✓ 
      Patent use: IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)



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 22, 2015 - NEW CHEMICAL ENTITY

    • January 22, 2017 - ORPHAN DRUG EXCLUSIVITY

See also...

  • 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)

No comments:

Post a Comment