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Generic Brisdelle Availability

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

BRISDELLE (paroxetine mesylate - capsule;oral)

  • Manufacturer: SEBELA IRELAND LTD
    Approval date: June 28, 2013
    Strength(s): EQ 7.5MG BASE [RLD]

Has a generic version of Brisdelle been approved?

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

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

  • 4-Phenylpiperidine compounds for treating depression
    Patent 5,874,447
    Issued: February 23, 1999
    Inventor(s): Benneker; Franciscus Bernardus Gemma & Van Dalen; Frans & Lemmens; Jacobus Maria & Peters; Theodorus Hendricus Antonium & Picha; Frantisek
    Assignee(s): Synthon B. V.
    The invention relates to a compound, and pharmaceutically acceptable salts, having the formula I: ##STR1## wherein: R represents an alkyl or alkynyl group having 1-4 carbon atoms, or a phenyl group optionally substituted by C.sub.1-4 alkyl, alkylthio, alkoxy, halogen, nitro, acylamino, methylsulfonyl or methylenedioxy, or represents tetrahydronaphthyl, R.sup.1 represents hydrogen, trifluoro (C.sub.1-4) alkyl, alkyl or alkynyl, X represents hydrogen, alkyl having 1-4 carbon atoms, alkoxy, trifluoroalkyl, hydroxy, halogen, methylthio or aralkoxy, R.sup.2 represents: a C1-C10 alkyl group, a phenyl group optionally substituted by one or more of the following groups: a C1-C10 alkyl group, a halogen group, a nitro group, hydroxy group, and/or an alkoxy group.
    Patent expiration dates:
    • June 10, 2017
      ✓ 
      Drug substance
  • Crystalline paroxetine methane sulfonate
    Patent 7,598,271
    Issued: October 6, 2009
    Inventor(s): Benneker; Franciscus Bernardus Gemma & Van Dalen; Frans & Lemmens; Jacobus Maria & Peters; Theodorus Hendricus Antonium & Picha; Frantisek
    Assignee(s): Noven Therapeutics, LLC
    The invention relates to a compound, and pharmaceutically acceptable salts, having the formula I: wherein: R represents an alkyl or alkynyl group having 1-4 carbon atoms, or a phenyl group optionally substituted by C1-4 alkyl, alkylthio, alkoxy, halogen, nitro, acylamino, methylsulfonyl or methylenedioxy, or represents tetrahydronaphthyl, R1 represents hydrogen, trifluoro (C1-4) alkyl, alkyl or alkynyl, X represents hydrogen, alkyl having 1-4 carbon atoms, alkoxy, trifluoroalkyl, hydroxy, halogen, methylthio or aralkoxy, R2 represents: a C1-C10 alkyl group, a phenyl group optionally substituted by one or more of the following groups: a C1-C10 alkyl group, a halogen group, a nitro group, hydroxy group, and/or an alkoxy group.
    Patent expiration dates:
    • May 4, 2025
      ✓ 
      Drug substance
  • Method of treating thermoregulatory disfunction with paroxetine
    Patent 8,658,663
    Issued: February 25, 2014
    Assignee(s): Noven Therapeutics, LLC
    The present invention relates to a method for treating a patient suffering from a thermoregulatory dysfunction, especially hot flashes and flushes associated with hormonal changes due to naturally occurring menopause (whether male or female) or due to chemically or surgically induced menopause. The method is also applicable to treating the hot flashes, hot flushes, or night sweats associated with disease states that disrupt normal hormonal regulation of body temperature.
    Patent expiration dates:
    • April 6, 2029
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Method of treating thermoregulatory dysfunction with paroxetine
    Patent 8,946,251
    Issued: February 3, 2015
    Assignee(s): Noven Therapeutics, LLC
    The present invention relates to a method for treating a patient suffering from a thermoregulatory dysfunction, especially hot flashes and flushes associated with hormonal changes due to naturally occurring menopause (whether male or female) or due to chemically or surgically induced menopause. The method is also applicable to treating the hot flashes, hot flushes, or night sweats associated with disease states that disrupt normal hormonal regulation of body temperature.
    Patent expiration dates:
    • August 4, 2026
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Method of treating thermoregulatory dysfunction with paroxetine
    Patent 9,393,237
    Issued: July 19, 2016
    Assignee(s): NOVEN THERAPEUTICS, LLC
    The present invention relates to a method for treating a patient suffering from a thermoregulatory dysfunction, especially hot flashes and flushes associated with hormonal changes due to naturally occurring menopause (whether male or female) or due to chemically or surgically induced menopause. The method is also applicable to treating the hot flashes, hot flushes, or night sweats associated with disease states that disrupt normal hormonal regulation of body temperature.
    Patent expiration dates:
    • August 4, 2026
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

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:
    • June 28, 2016 - NEW PRODUCT

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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