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Generic Axiron Availability

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

AXIRON (testosterone - solution, metered;transdermal)

  • Manufacturer: ELI LILLY AND CO
    Approval date: November 23, 2010
    Strength(s): 30MG/1.5ML ACTUATION [RLD] [AT]

Has a generic version of Axiron been approved?

A generic version of Axiron has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Axiron and have been approved by the FDA:

testosterone solution, metered;transdermal

  • Manufacturer: ACTAVIS LABS UT INC
    Approval date: August 7, 2017
    Strength(s): 30MG/1.5ML ACTUATION [AT]
  • Manufacturer: PERRIGO ISRAEL
    Approval date: February 28, 2017
    Strength(s): 30MG/1.5ML ACTUATION [AT]

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

  • Dermal penetration enhancers and drug delivery systems involving same
    Patent 6,299,900
    Issued: October 9, 2001
    Inventor(s): Reed; Barry Leonard & Morgan; Timothy Matthias & Finnin; Barrie Charles
    Assignee(s): Monash University
    A transdermal drug delivery system which comprises at least one physiologically active agent or prodrug thereof and at least one dermal penetration enhancer; characterized in that the dermal penetration enhancer is a safe skin-tolerant ester sunscreen. A non-occlusive, percutaneous or transdermal drug delivery system which comprises: (i) an effective amount of at least one physiologically active agent or prodrug thereof; (ii) at least one non-volatile dermal penetration enhancer; and (iii) at least one volatile liquid; characterised in that the dermal penetration enhancer is adapted to transport the physiologically active agent across a dermal surface or mucosal membrane of an animal, including a human, when the volatile liquid evaporates, to form a reservoir or depot of a mixture comprising the penetration enhancer and the physiologically active agent or prodrug within said surface or membrane; and the dermal penetration enhancer is of low toxicity to, and is tolerated by, the dermal surface or mucosal membrane of the animal.
    Patent expiration dates:
    • February 19, 2017
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      Patent use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
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      Drug product
  • Dermal penetration enhancers and drug delivery systems involving same
    Patent 6,818,226
    Issued: November 16, 2004
    Inventor(s): Barry Leonard; Reed & Timothy Matthias; Morgan & Barrie Charles; Finnin
    Assignee(s): ACRUX DDS Pty. Ltd.
    A transdermal drug delivery system which comprises at least one physiologically active agent or prodrug thereof and at least one dermal penetration enhancer; characterised in that the dermal penetration enhancer is a safe skin-tolerant ester sunscreen. A non-occlusive, percutaneous or transdermal drug delivery system which comprises: (i) an effective amount of at least one physiologically active agent or prodrug thereof; (ii) at least one non-volatile dermal penetration enhancer; and (iii) at least one volatile liquid; characterised in that the dermal penetration enhancer is adapted to transport the physiologically active agent across a dermal surface or mucosal membrane of an animal, including a human, when the volatile liquid evaporates, to form a reservoir or depot of a mixture comprising the penetration enhancer and the physiologically active agent or prodrug within said surface or membrane; and the dermal penetration enhancer is of low toxicity to, and is tolerated by, the dermal surface or mucosal membrane of the animal.
    Patent expiration dates:
    • February 19, 2017
      ✓ 
      Patent use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
      ✓ 
      Drug product
  • Transdermal delivery of hormones
    Patent 6,923,983
    Issued: August 2, 2005
    Inventor(s): Morgan; Timothy Matthias & Bakalova; Margarita Vladislavova & Klose; Karthryn Traci-Jane & Finnin; Barrie Charles & Reed; Barry Leonard
    Assignee(s): Acrux DDS PTY LTD
    The present invention provides a transdermal drug delivery system which comprises: a therapeutically effective amount of a hormone; at least one dermal penetration enhancer, which is a safe skin-tolerant ester sunscreen ester; and at least one volatile liquid. The invention also provides a method for administering at least one systemic acting hormone to an animal which comprises applying an effective amount of the hormone in the form of the drug delivery system of the present invention
    Patent expiration dates:
    • February 19, 2017
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      Patent use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
      ✓ 
      Drug product
  • Dermal penetration enhancers and drug delivery systems involving the same
    Patent 8,071,075
    Issued: December 6, 2011
    Inventor(s): Reed; Barry Leonard & Morgan; Timothy Matthias & Finnin; Barrie Charles
    Assignee(s): Acrux DDS Pty Ltd.
    The invention relates to a method for treatment or prophylaxis of a disease or condition in an animal comprising administering to a mucosal membrane of said animal in need of such treatment a therapeutically effective amount of a drug delivery system comprising at least one physiologically active agent or prodrug thereof and at least one penetration enhancer selected from safe ester sunscreens.
    Patent expiration dates:
    • February 19, 2017
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      Patent use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
      ✓ 
      Drug product
  • Spreading implement
    Patent 8,419,307
    Issued: April 16, 2013
    Assignee(s): Acrux DDS Pty Ltd.
    Described are methods comprising applying a liquid pharmaceutical testosterone composition with an implement comprising a support and a receptacle mounted on the support and defining a reservoir space with an open top to receive the liquid, wherein the receptacle includes a flexible membrane integrally forming a base and a wall, the wall being substantially transverse to the base and having a working surface to spread the liquid over the treatment surface, wherein the base has a continuous surface such that liquid cannot pass through the base, wherein the wall includes an inner portion which extends from the base to an upper end and an outer skirt portion, wherein the inner portion and skirt portion form a double-wall structure, and wherein at least the wall is resiliently deformable so the working surface maintains contact with the treatment surface when spreading the liquid.
    Patent expiration dates:
    • February 26, 2027
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      Patent use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF A PERSON IN NEED THEREOF
  • Method and composition for transdermal drug delivery
    Patent 8,435,944
    Issued: May 7, 2013
    Assignee(s): Acrux DDS Pty Ltd.
    The invention is directed to a transdermal drug delivery composition which includes at least one physiologically active agent; and at least one volatile solvent; and at least one viscosity modulating agent. The invention extends to methods of administering such a composition to a subject and treatment of subjects using the composition.
    Patent expiration dates:
    • September 27, 2027
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      Patent use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
  • Transdermal delivery rate control using amorphous pharmaceutical compositions
    Patent 8,784,878
    Issued: July 22, 2014
    Assignee(s): Acrux DDS Pty Ltc.
    A pharmaceutical composition for transdermal delivery comprising one or more physiologically active agents; one or more dermal penetration enhancers; and a volatile pharmaceutically acceptable carrier comprising a volatile solvent; and wherein the physiologically active agent and dermal penetration enhancer form an amorphous deposit upon evaporation of the volatile carrier, said amorphous deposit forming a reservoir within the stratum corneum; and (A) wherein the composition has a release rate profile of physiologically active agent so as to provide a ratio of the maximum concentration (Cmax) to the average concentration (Cavg) for the physiologically active agent over the dosage interval within the range of 1 to 10.
    Patent expiration dates:
    • July 13, 2023
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      Patent use: A METHOD OF TRANSDERMALLY DELIVERING TESTOSTERONE
      ✓ 
      Drug product
  • Spreading implement
    Patent 8,807,861
    Issued: August 19, 2014
    Assignee(s): Acrux DDS Pty Ltd.
    An implement 1 for applying a volume of liquid to a treatment surface can include a support 3 onto which is mounted a receptacle 2, the receptacle defining a reservoir space 4 which receives the liquid. The receptacle includes a wall 6 having a working surface that is used to spread the liquid over the treatment surface. The wall 6 is resiliently deformable so in use the working surface maintains contact with the treatment surface when spreading the liquid. The implement has a specific application in applying a transdermal lotion to the axilla area of the user. A system for transdermal administration of a physiological active agent from a liquid composition and a method of using this system are described.
    Patent expiration dates:
    • February 26, 2027
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      Patent use: A METHOD OF TRANSDERMAL ADMINISTRATION OF A PHYSIOLOGICALLY ACTIVE AGENT TO A SUBJECT.
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      Drug product
  • Method and composition for transdermal drug delivery
    Patent 8,993,520
    Issued: March 31, 2015
    Assignee(s): Acrux DDS Pty Ltd
    The invention is directed to a transdermal drug delivery composition which includes at least one physiologically active agent; and at least one volatile solvent; and at least one viscosity modulating agent. The invention extends to methods of administering such a composition to a subject and treatment of subjects using the composition.
    Patent expiration dates:
    • June 2, 2026
      ✓ 
      Patent use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
  • Method and composition for transdermal drug delivery
    Patent 9,180,194
    Issued: November 10, 2015
    Assignee(s): ACRUX DDS PTY LTD
    The invention is directed to a transdermal drug delivery composition which includes at least one physiologically active agent; and at least one volatile solvent; and at least one viscosity modulating agent. The invention extends to methods of administering such a composition to a subject and treatment of subjects using the composition.
    Patent expiration dates:
    • June 2, 2026
      ✓ 
      Patent use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
  • Spreading implement
    Patent 9,289,586
    Issued: March 22, 2016
    Assignee(s): ACRUX DDS PTY LTD
    An implement for applying a volume of liquid to a treatment surface includes a support onto which is mounted a receptacle. The receptacle defines a reservoir space which receives the liquid. The receptacle includes a wall having a working surface that is used to spread the liquid over the treatment surface. The wall is resiliently deformable such that in use the working surface maintains contact with the treatment surface when spreading the liquid. The implement is used in applying a transdermal lotion to the axilla area of a user. A system for transdermal administration of a physiological active agent from a liquid composition and a method of conducting the same are also provided.
    Patent expiration dates:
    • February 26, 2027
      ✓ 
      Patent use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
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.
ATTopical products. There are a variety of topical dosage forms available for dermatologic, ophthalmic, otic, rectal, and vaginal administration, including creams, gels, lotions, oils, ointments, pastes, solutions, sprays and suppositories. Even though different topical dosage forms may contain the same active ingredient and potency, these dosage forms are not considered pharmaceutically equivalent. Therefore, they are not considered therapeutically equivalent. All solutions and DESI drug products containing the same active ingredient in the same topical dosage form for which a waiver of in vivo bioequivalence has been granted and for which chemistry and manufacturing processes are adequate to demonstrate bioequivalence, are considered therapeutically equivalent and coded AT. Pharmaceutically equivalent topical products that raise questions of bioequivalence, including all post-1962 non-solution topical drug products, are coded AB when supported by adequate bioequivalence data, and BT in the absence of such data.
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