Generic Synera Availability

Synera is a brand name of lidocaine/tetracaine topical, approved by the FDA in the following formulation(s):

SYNERA (lidocaine; tetracaine - patch;topical)

  • Manufacturer: GALEN SPECIALTY
    Approval date: June 23, 2005
    Strength(s): 70MG;70MG [RLD]

Has a generic version of Synera been approved?

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

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

  • Apparatus and methods for improved noninvasive dermal administration of pharmaceuticals
    Patent 5,658,583
    Issued: August 19, 1997
    Inventor(s): Zhang; Jie & Zhang; Hao
    An apparatus, product formulation, and method for improved dermal permeation of pharmaceuticals wherein the apparatus includes a thin drug formulation reservoir and a heat-generating chamber separated by a first non-permeable wall, wherein the reservoir and chamber are formed in or supported by a housing. The drug formulation reservoir houses or is capable of housing a predetermined amount of a formulation containing pharmaceutically-active agent(s). The heat-generating/temperature-regulating chamber includes a medium for generating controlled heat, preferably a chemical composition made of carbon, iron, water and/or salt which is activated upon contact with air (oxygen). The function of the heat-generating/temperature-regulating element is to heat the user's skin, rapidly bring the skin temperature to a desired and elevated narrow range and keep it in this range for sufficient time to obtain more rapid, enhanced and less variable dermal absorption of selected pharmaceutically-active agents and to obtain improved clinical effects. Structure for controlling the generation of heat is also disclosed. The apparatus may optionally include a spacing or standoff structure which spans the drug formulation reservoir between the non-permeable wall and the user's skin surface for maintaining a predetermined thickness of the drug formulation on the user's skin surface. Also, a novel product formulation which can be used with the apparatus which uses high percentage of eutectic mixture of local anesthetics to reduce the overall degradation rate of the local anesthetic compound(s) in formulations which are subject to hydrolysis.
    Patent expiration dates:
    • July 28, 2015
      ✓ 
      Drug product
  • Noninvasive dermal anesthetics
    Patent 5,919,479
    Issued: July 6, 1999
    Inventor(s): Zhang; Jie & Zhang; Hao
    Assignee(s): Zars, Inc.
    An apparatus, product formulation, and method for improved dermal permeation of pharmaceuticals wherein the apparatus includes a thin drug formulation reservoir and a heat-generating chamber separated by a first non-permeable wall, wherein the reservoir and chamber are formed in or supported by a housing. The drug formulation reservoir houses or is capable of housing a predetermined amount of a formulation containing pharmaceutically-active agent(s). The heat-generating/temperature-regulating chamber includes a medium for generating controlled heat, preferably a chemical composition made of carbon, iron, water and/or salt which is activated upon contact with air (oxygen). The function of the heat-generating/temperature-regulating element is to heat the user's skin, rapidly bring the skin temperature to a desired and elevated narrow range and keep it in this range for sufficient time to obtain more rapid, enhanced and less variable dermal absorption of selected pharmaceutically-active agents and to obtain improved clinical effects. Structure for controlling the generation of heat is also disclosed. The apparatus may optionally include a spacing or standoff structure which spans the drug formulation reservoir between the non-permeable wall and the user's skin surface for maintaining a predetermined thickness of the drug formulation on the user's skin surface. Also, a novel product formulation which can be used with the apparatus which uses high percentage of eutectic mixture of local anesthetics to reduce the overall degradation rate of the local anesthetic compound(s) in formulations which are subject to hydrolysis.
    Patent expiration dates:
    • July 28, 2015
      ✓ 
      Drug product
  • Apparatus for heating to a desired temperature for improved administration of pharmaceutically active compounds
    Patent 6,306,431
    Issued: October 23, 2001
    Inventor(s): Zhang; Jie & Zhang; Hao
    Assignee(s): Zars, Inc.
    Methods and apparatus for improving administration of drugs through the use of heat and other physical means. The present invention relates to the use of heat and other physical means in conjunction with specially designed dermal drug delivery systems, conventional commercial dermal drug delivery systems, or drugs delivered into a sub-skin depot site via injection and other methods to alter, mainly increase, the drug release rate from the dermal drug delivery systems or the depot sites to accommodate certain clinical needs.
    Patent expiration dates:
    • July 28, 2015
      ✓ 
      Drug product
  • Method for facilitating absorption of pharmaceutically active compounds
    Patent 6,465,006
    Issued: October 15, 2002
    Inventor(s): Jie; Zhang & Hao; Zhang
    Assignee(s): Zars, Inc.
    Methods and apparatus for improving administration of drugs through the use of heat and other physical means. The present invention relates to the use of heat and other physical means in conjunction with specially designed dermal drug delivery systems, conventional commercial dermal drug delivery systems, or drugs delivered into a sub-skin depot site via injection and other methods to alter, mainly increase, the drug release rate from the dermal drug delivery systems or the depot sites to accommodate certain clinical needs.
    Patent expiration dates:
    • July 28, 2015
      ✓ 
      Drug product
  • Exothermic bandage
    Patent 6,465,709
    Issued: October 15, 2002
    Inventor(s): Ying; Sun & Ralph W.; Oakeson & Stephen J.; Wisniewski & Jonas C. T.; Wang
    Assignee(s): Johnson & Johnson Consumer Companies, Inc.
    The present invention relates to a multi-layer exothermic bandage comprising an oxygen-impermeable layer, a water-impermeable layer, a heating element layer comprising an oxidizable material, and an active agent layer; and the use thereof.
    Patent expiration dates:
    • July 7, 2020
      ✓ 
      Drug product
  • Integrated apparatus for controlled heat aided dermal drug delivery
    Patent 6,546,281
    Issued: April 8, 2003
    Inventor(s): Jie; Zhang & Hao; Zhang & Wade A.; Hull & Larry; Rigby
    Assignee(s): Zars, Inc.
    An integrated apparatus for controlled heat aided dermal drug delivery is disclosed. The apparatus has a temperature control component and a drug delivery component. The temperature control component may and dermal drug delivery component are an integrated unit. The apparatus also comprises means to prevent exchange of substance(s) among the heat generating component, the drug delivery component and the outside environment. The apparatus is designed to be easy to use.
    Patent expiration dates:
    • July 28, 2015
      ✓ 
      Drug product
  • Method and apparatus for improved heat controlled administration of pharmaceuticals
    Patent 6,780,426
    Issued: August 24, 2004
    Inventor(s): Jie; Zhang & Hao; Zhang
    Assignee(s): Zars, Inc.
    The present invention features methods and apparatus'for improving administration of drugs through the use of specifically controlled heat and other physical means. The present invention relates to the use of heat and other physical means in conjunction with specially designed dermal drug delivery systems, conventional commercial dermal drug delivery systems, or drugs delivered into a sub-skin depot site via injection and other methods to alter, mainly increase, the drug release rate from the dermal drug delivery systems or the depot sites to accommodate certain clinical needs.
    Patent expiration dates:
    • July 28, 2015
      ✓ 
      Drug 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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