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Generic Natesto Availability

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

NATESTO (testosterone - gel, metered;nasal)

  • Manufacturer: AYTU BIOSCIENCE INC
    Approval date: May 28, 2014
    Strength(s): 5.5MG/0.122GM ACTUATION

Has a generic version of Natesto been approved?

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

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

  • Controlled release delivery system for nasal applications
    Patent 8,574,622
    Issued: November 5, 2013
    Assignee(s): M & P Patent Aktiengesellschaft
    This invention relates to a pernasally administrable preparation for the controlled release of sexual hormones to the systemic circulation, in particular to a formulation which enables its active ingredient to be absorbed in a sustained manner providing a better bioavailability at very low doses and longer duration of action.
    Patent expiration dates:
    • February 4, 2024
      ✓ 
      Drug product
  • Controlled release delivery system for nasal applications and methods of treatment
    Patent 8,784,869
    Issued: July 22, 2014
    Assignee(s): Mattern Pharma AG
    This invention relates to a gel formulation for nasal administration of a controlled release formulation of hormones to the systemic circulation and/or to the brain. The special lipophilic or partly lipophilic system of the invention leads to higher bioavailability of the active ingredient caused by sustained serum levels in plasma but also leads to a more favorable serum level profile. The special lipophilic or partly lipophilic system also allows for the modulation of brain functioning. The invention also relates to the nasal administration of steroid hormones for treatment of female sexual dysfunction (FSD) or female arousal disorder.
    Patent expiration dates:
    • February 4, 2024
      ✓ 
      Drug product
  • Controlled release delivery system for nasal applications and method of treatment
    Patent 8,784,882
    Issued: July 22, 2014
    Assignee(s): Mattern Pharma AG
    This invention relates to a gel formulation for nasal administration of a controlled release formulation of hormones to the systemic circulation and/or to the brain. The special lipophilic or partly lipophilic system of the invention leads to higher bioavailability of the active ingredient caused by sustained serum levels in plasma but also leads to a more favorable serum level profile. The special lipophilic or partly lipophilic system also allows for the modulation of brain functioning. The invention also relates to the nasal administration of steroid hormones for treatment of female sexual dysfunction (FSD) or female arousal disorder.
    Patent expiration dates:
    • February 4, 2024
      ✓ 
      Patent use: A METHOD OF TESTOSTERONE REPLACEMENT THERAPY COMPRISING THE STEP OF NASALLY ADMINISTERING TO A PATIENT IN NEED OF SUCH TREATMENT AN EFFECTIVE AMOUNT OF TESTOSTERONE GEL FORMULATION.
      ✓ 
      Drug product
  • Controlled release delivery system for nasal applications
    Patent 8,877,230
    Issued: November 4, 2014
    Assignee(s): Mattern Pharma AG
    This invention relates to a pernasally administrable preparation for the controlled release of sexual hormones to the systemic circulation, in particular to a formulation which enables its active ingredient to be absorbed in a sustained manner providing a better bioavailability at very low doses and longer duration of action.
    Patent expiration dates:
    • February 4, 2024
      ✓ 
      Patent use: NASAL ADMINISTRATION OF A TESTOSTERONE GEL TO A PATIENT TO TREAT THE PATIENT FOR A CONDITION ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE

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, 2017 - NEW PRODUCT
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More about Natesto (testosterone)

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Professional resources

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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.

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