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Generic Intermezzo Availability

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

INTERMEZZO (zolpidem tartrate - tablet;sublingual)

  • Manufacturer: PURDUE PHARMA
    Approval date: November 23, 2011
    Strength(s): 1.75MG, 3.5MG [RLD]

Has a generic version of Intermezzo been approved?

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

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

  • Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof
    Patent 7,658,945
    Issued: February 9, 2010
    Inventor(s): Singh; Nikhilesh N.
    Assignee(s): Transcept Pharmaceuticals, Inc.
    The present invention provides novel compositions for the delivery of a hypnotic agent across the oral mucosa. In particular, the buffer system in the compositions of the present invention raises the pH of saliva to a pH greater than about 7.8, thereby facilitating the substantially complete conversion of the hypnotic agent from its ionized to its un-ionized form. As a result, the dose of hypnotic agent is rapidly and efficiently absorbed by the oral mucosa with surprisingly low inter-subject variability. Furthermore, delivery of the hypnotic agent across the oral mucosa advantageously bypasses hepatic first pass metabolism of the drug and avoids enzymatic degradation of the drug within the gastrointestinal tract. Methods for using the compositions of the present invention for treating sleep disorders such as insomnia are also provided.
    Patent expiration dates:
    • April 15, 2027
      ✓ 
      Patent use: METHOD FOR TREATING INSOMNIA
      ✓ 
      Drug product
  • Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof
    Patent 7,682,628
    Issued: March 23, 2010
    Inventor(s): Singh; Nikhilesh N.
    Assignee(s): Transcept Pharmaceuticals, Inc.
    The present invention provides novel compositions for the delivery of a hypnotic agent across the oral mucosa. In particular, the buffer system in the compositions of the present invention raises the pH of saliva to a pH greater than about 7.8, thereby facilitating the substantially complete conversion of the hypnotic agent from its ionized to its un-ionized form. As a result, the dose of hypnotic agent is rapidly and efficiently absorbed by the oral mucosa with surprisingly low inter-subject variability. Furthermore, delivery of the hypnotic agent across the oral mucosa advantageously bypasses hepatic first pass metabolism of the drug and avoids enzymatic degradation of the drug within the gastrointestinal tract. Methods for using the compositions of the present invention for treating sleep disorders such as insomnia are also provided.
    Patent expiration dates:
    • February 16, 2025
      ✓ 
      Patent use: METHOD FOR TREATING INSOMNIA
  • Methods of treating middle-of-the-night insomnia
    Patent 8,242,131
    Issued: August 14, 2012
    Inventor(s): Singh; Nikhilesh & Pather; Sathasivan Indiran
    Assignee(s): Transcept Pharmaceuticals, Inc.
    The present invention provides compositions and methods for treating middle-of-the-night insomnia without residual sedative effects upon awakening by administering low doses (about 5 mg or less) of zolpidem or a salt thereof.
    Patent expiration dates:
    • August 20, 2029
      ✓ 
      Patent use: METHOD OF TREATING MIDDLE-OF-THE-NIGHT INSOMNIA
  • Compositions for treating insomnia
    Patent 8,252,809
    Issued: August 28, 2012
    Inventor(s): Singh; Nikhilesh N.
    Assignee(s): Transcept Pharmaceuticals, Inc.
    The present invention provides compositions for treating middle-of-the-night insomnia without residual sedative effects upon awakening by administering low doses (about 5 mg or less) of zolpidem or a salt thereof.
    Patent expiration dates:
    • February 16, 2025
      ✓ 
      Drug product

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:
    • November 23, 2014 -

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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