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Generic Xadago Availability

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

XADAGO (safinamide mesylate - tablet;oral)

  • Manufacturer: US WORLDMEDS LLC
    Approval date: March 21, 2017
    Strength(s): 50MG [RLD], 100MG [RLD]

Has a generic version of Xadago been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xadago. 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: Generic Drug FAQs.

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.

  • Process for the production of 2-[4-(3- and 2-fluorobenzyloxy) benzylamino] propanamides
    Patent 8,076,515
    Issued: December 13, 2011
    Inventor(s): Barbanti; Elena & Caccia; Carla & Salvati; Patricia & Velardi; Francesco & Ruffilli; Tiziano & Bogogna; Luigi
    Assignee(s): Newron Pharmaceuticals S.p.A.

    A process for obtaining therapeutically active 2-[4-(3- and 2-(fluorobenzyloxy)benzylamino]propanamides and their salts with pharmaceutically acceptable acids with high purity degree, in particular, with a content of dibenzyl derivatives impurities lower than 0.03%, preferably lower than 0.01% by weight. The process is carried out by submitting the Schiff bases intermediates 2-[4-(3- and 2-fluorobenzyloxy)benzylideneamino]propanamides to catalytic hydrogenation in the presence of a heterogeneous catalyst in a protic organic solvent.

    Patent expiration dates:

    • December 10, 2028
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      Patent use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE EXPERIENCING 'OFF' EPISODES
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      Drug substance
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      Drug product
  • Process for the production of 2-[4-(3- and 2-fluorobenzyloxy) benzylamino] propanamides
    Patent 8,278,485
    Issued: October 2, 2012
    Inventor(s): Barbanti; Elena & Caccia; Carla & Salvati; Patricia & Velardi; Francesco & Ruffilli; Tiziano & Bogogna; Luigi
    Assignee(s): Newron Pharmaceuticals S.p.A.

    A process for obtaining therapeutically active 2-[4-(3- and 2-(fluorobenzyloxy)benzylamino]propanamides and their salts with pharmaceutically acceptable acids with high purity degree, in particular, with a content of dibenzyl derivatives impurities lower than 0.03%, preferably lower than 0.01% by weight. The process is carried out by submitting the Schiff bases intermediates 2-[4-(3- and 2-fluorobenzyloxy)benzylideneamino]propanamides to catalytic hydrogenation in the presence of a heterogeneous catalyst in a protic organic solvent.

    Patent expiration dates:

    • June 8, 2027
      ✓ 
      Patent use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE EXPERIENCING 'OFF' EPISODES
      ✓ 
      Drug substance
  • Methods for treatment of parkinson's disease
    Patent 8,283,380
    Issued: October 9, 2012
    Inventor(s): Fariello; Ruggero & Cattaneo; Carlo & Salvati; Patricia & Benatti; Luca
    Assignee(s): Newron Pharmaceuticals S.p.A.

    New uses of safinamide, safinamide derivatives and MAO-B inhibitors in novel types of treatment for Parkinson's Disease are described. More specifically, the invention relates to methods for treating Parkinson's Disease through the administration of safinamide, a safinamide derivative, or a MAO-B inhibitor, in combination with other Parkinson's Disease agents or treatments, such as levodopa/PDI or dopamine agonists.

    Patent expiration dates:

    • September 1, 2027
      ✓ 
      Patent use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE EXPERIENCING 'OFF' EPISODES

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:

    • March 21, 2022 - NEW CHEMICAL ENTITY

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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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