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Generic Osmolex ER Availability

Osmolex ER is a brand name of amantadine, approved by the FDA in the following formulation(s):

OSMOLEX ER (amantadine hydrochloride - tablet, extended release;oral)

  • Manufacturer: OSMOTICA PHARM
    Approval date: February 16, 2018
    Strength(s): EQ 129MG BASE [RLD], EQ 193MG BASE [RLD], EQ 258MG BASE [RLD]
  • Manufacturer: OSMOTICA PHARM
    Approval date: April 22, 2020
    Strength(s): EQ 161MG BASE [RLD]

Has a generic version of Osmolex ER been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Osmolex ER. 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.

  • Composition and method for treating neurological disease
    Patent 10,213,393
    Issued: February 26, 2019
    Assignee(s): Osmotica Kereskedelmi és Szolgáltató Korlátolt Feleõsségû Társaság

    The present disclosure is directed to methods of treating neurological disorders in a patient such as Parkinson's disease, drug-induced extrapyramidal reactions, and/or levodopa-induced dyskinesia comprising administering to the patient once daily in the morning a pharmaceutical composition comprising about 50 mg to about 400 mg of extended-release amantadine or a pharmaceutically acceptable salt thereof.

    Patent expiration dates:

    • February 15, 2038
      ✓ 
      Patent use: A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT
  • Composition and method for treating neurological disease
    Patent 10,213,394
    Issued: February 26, 2019
    Assignee(s): Osmotica Kereskedelmi és Szolgáltató Korlátolt Felelõsségû Társaság

    The present disclosure is directed to methods of treating neurological disorders in a patient such as Parkinson's disease, drug-induced extrapyramidal reactions, and/or levodopa-induced dyskinesia comprising administering to the patient once daily in the morning a pharmaceutical composition comprising about 50 mg to about 400 mg of extended-release amantadine or a pharmaceutically acceptable salt thereof.

    Patent expiration dates:

    • February 15, 2038
      ✓ 
      Patent use: TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
  • Patent 10,500,170

    Patent expiration dates:

    • February 15, 2038
      ✓ 
      Patent use: A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT
  • Patent 10,500,171

    Patent expiration dates:

    • February 15, 2038
      ✓ 
      Patent use: TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
  • Patent 10,500,172

    Patent expiration dates:

    • February 15, 2038
      ✓ 
      Patent use: TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
  • Composition and method for treating neurological disease
    Patent 10,512,617
    Issued: December 24, 2019
    Assignee(s): Osmotica Kereskedelmi és Szolgáltató Korlátolt Felelösségû Társaság

    The present disclosure is directed to methods of treating neurological disorders in a patient such as Parkinson's disease, drug-induced extrapyramidal reactions, and/or levodopa-induced dyskinesia comprising administering to the patient once daily in the morning a pharmaceutical composition comprising about 50 mg to about 400 mg of extended-release amantadine or a pharmaceutically acceptable salt thereof.

    Patent expiration dates:

    • February 15, 2038
      ✓ 
      Patent use: TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
  • Osmotic device containing amantadine and an osmotic salt
    Patent 8,252,331
    Issued: August 28, 2012
    Inventor(s): Meyer; Glenn A. & Feleder; Ethel C. & Ricci; Marcelo A. & Coppari; Marcelo A. & Befumo; Marcelo F. & Faour; Joaquina & Vergez; Juan A.
    Assignee(s): Osmotica Kereskedelmi és Szolgáltató, KFT

    The osmotic devices of the present invention contain a unitary core comprising a salt of amantadine and an osmotic salt, wherein the two salts have an ion in common. The release rate of the amantadine is modified from a first order release profile to a zero order, pseudo-zero order or sigmoidal release profile by increasing the amount of the osmotic salt in the core of the device. The osmotic device includes a semipermeable membrane having a controlled porosity that can be adapted as needed to cooperate with the osmotic salt in providing a predetermined drug release profile. The osmotic salt need not be coated and it is in admixture with the amantadine salt.

    Patent expiration dates:

    • March 13, 2030
      ✓ 
      Drug product
  • Osmotic device containing amantadine and an osmotic salt
    Patent 8,574,626
    Issued: November 5, 2013
    Assignee(s): Osmotica Kereskedelmi és Szolgáltató KFT

    The osmotic devices of the present invention contain a unitary core comprising a salt of amantadine and an osmotic salt, wherein the two salts have an ion in common. The release rate of the amantadine is a sigmoidal release. The osmotic device includes a semipermeable membrane having a controlled porosity that can be adapted as needed to cooperate with the osmotic salt in providing a predetermined drug release profile. The osmotic salt need not be coated and it is in admixture with the amantadine salt. The osmotic device further includes a drug-containing coat external to the semipermeable membrane. The osmotic device can include one or more additional drugs in the core and/or the drug-containing coat.

    Patent expiration dates:

    • November 28, 2025
      ✓ 
      Patent use: A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT
      ✓ 
      Drug product

Further information

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

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.