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Generic Lybalvi Availability

Last updated on Nov 8, 2022.

Lybalvi is a brand name of olanzapine/samidorphan, approved by the FDA in the following formulation(s):

LYBALVI (olanzapine; samidorphan l-malate - tablet;oral)

  • Manufacturer: ALKERMES INC
    Approval date: May 28, 2021
    Strength(s): 5MG;EQ 10MG BASE [RLD], 10MG;EQ 10MG BASE [RLD], 15MG;EQ 10MG BASE [RLD], 20MG;EQ 10MG BASE [RLD]

Has a generic version of Lybalvi been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lybalvi. 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 FAQ.

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.

  • Methods for treating antipsychotic-induced weight gain
    Patent 10,300,054
    Issued: May 28, 2019
    Assignee(s): Alkermes Pharma Ireland Limited

    The present invention relates to the discovery of a novel opioid modulator effective in reducing pharmacologically induced weight gain associated with atypical antipsychotic use. The present invention provides methods of reducing antipsychotic induced weight gain, methods for suppressing food intake and reducing ghrelin levels induced by atypical antipsychotic medications in a patient.

    Patent expiration dates:

    • August 23, 2031
      ✓ 
      Patent use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
      ✓ 
      Drug product
    • August 23, 2031
      ✓ 
      Patent use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
      ✓ 
      Drug product
  • Patent 10,716,785

    Patent expiration dates:

    • August 23, 2031
      ✓ 
      Patent use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
    • August 23, 2031
      ✓ 
      Patent use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
  • Patent 11,185,541

    Patent expiration dates:

    • August 23, 2031
      ✓ 
      Patent use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
  • Patent 11,241,425

    Patent expiration dates:

    • August 23, 2031
      ✓ 
      Patent use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
  • Patent 11,351,166

    Patent expiration dates:

    • August 23, 2031
      ✓ 
      Patent use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
    • August 23, 2031
      ✓ 
      Patent use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
  • 4-hydroxybenzomorphans
    Patent 7,262,298
    Issued: August 28, 2007
    Inventor(s): Wentland; Mark P.
    Assignee(s): Rensselaer Polytechnic Institute

    4-Hydroxybenzomorphans containing carboxamide or thiocarboxamide at the 3-position are useful as analgesics, anti-diarrheal agents, anticonvulsants, antitussives and anti-addiction medications.

    Patent expiration dates:

    • November 23, 2025
      ✓ 
      Drug substance
  • Methods for treating antipsychotic-induced weight gain
    Patent 8,778,960
    Issued: July 15, 2014
    Assignee(s): Alkermes Pharma Ireland Limited

    The present invention relates to the discovery of a novel opioid modulator effective in reducing pharmacologically induced weight gain associated with atypical antipsychotic use. The present invention provides methods of reducing antipsychotic induced weight gain, methods for suppressing food intake and reducing ghrelin levels induced by atypical antipsychotic medications in a patient.

    Patent expiration dates:

    • February 13, 2032
      ✓ 
      Patent use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
    • February 13, 2032
      ✓ 
      Patent use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
  • Morphinan derivatives for the treatment of drug overdose
    Patent 9,119,848
    Issued: September 1, 2015
    Assignee(s): Alkermes Pharma Ireland Limited

    The instant application relates to morphinan derivatives of Formula I with sustained effectiveness in treating drug toxicity and overdose:

    Patent expiration dates:

    • August 30, 2031
      ✓ 
      Drug substance
  • Methods for treating antipsychotic-induced weight gain
    Patent 9,126,977
    Issued: September 8, 2015
    Assignee(s): Alkermes Pharma Ireland Limited

    The present invention relates to the discovery of a novel opioid modulator effective in reducing pharmacologically induced weight gain associated with atypical antipsychotic use. The present invention provides methods of reducing antipsychotic induced weight gain, methods for suppressing food intake and reducing ghrelin levels induced by atypical antipsychotic medications in a patient.

    Patent expiration dates:

    • August 23, 2031
      ✓ 
      Patent use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
      ✓ 
      Drug product
    • August 23, 2031
      ✓ 
      Patent use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
      ✓ 
      Drug product
  • Methods for treating antipsychotic-induced weight gain
    Patent 9,517,235
    Issued: December 13, 2016
    Assignee(s): Alkermes Pharma Ireland Limited

    The present invention relates to the discovery of a novel opioid modulator effective in reducing pharmacologically induced weight gain associated with atypical antipsychotic use. The present invention provides methods of reducing antipsychotic induced weight gain, methods for suppressing food intake and reducing ghrelin levels induced by atypical antipsychotic medications in a patient.

    Patent expiration dates:

    • August 23, 2031
      ✓ 
      Patent use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCTION OF THE ADVERSE METABOLIC PROFILE
    • August 23, 2031
      ✓ 
      Patent use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCTION OF THE ADVERSE METABOLIC PROFILE

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:

    • May 28, 2026 - NEW CHEMICAL ENTITY

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.

Further information

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