Generic Azmiro Availability
Last updated on May 7, 2025.
Azmiro is a brand name of testosterone, approved by the FDA in the following formulation(s):
AZMIRO (testosterone cypionate - solution;intramuscular)
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Manufacturer: AZURITY
Approval date: June 2, 2022
Strength(s): 200MG/ML (200MG/ML) [RLD]
Is there a generic version of Azmiro available?
No. There is currently no therapeutically equivalent version of Azmiro available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Azmiro. 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: Generic Drug FAQ.
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.
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Pharmaceutical compositions of testosterone
Patent 11,311,554
Issued: April 26, 2022
Inventor(s): Soni; Umangi K. et al.
Assignee(s): SLAYBACK PHARMA LLC (Princeton, NJ)The present invention provides stable pharmaceutical compositions, comprising a pharmaceutically effective amount of testosterone or a pharmaceutically acceptable ester thereof, a pharmaceutically acceptable oil vehicle, and a stabilizing amount of benzyl alcohol, for example, about 1% to 3% weight/volume of benzyl alcohol. The present invention also provides a process for stabilizing testosterone-containing pharmaceutical compositions by ageing them at a temperature of about 20° C. to about 60° C. for at least 48 hours, e.g., prior to secondary packing and labeling. These compositions were stable over the shelf life of the product, without exhibiting crystal formation, even upon storing at temperatures of about 2° C. to about 8° C. Other aspects of the invention relate to methods for making such pharmaceutical compositions, and methods of using such pharmaceutical compositions for hormone replacement therapy, e.g., in a male patient having a condition associated with symptoms of deficiency or absence of endogenous testosterone.
Patent expiration dates:
- March 25, 2039✓
- March 25, 2039
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Pharmaceutical compositions of testosterone
Patent 11,642,355
Issued: May 9, 2023
Inventor(s): Soni; Umangi K. et al.
Assignee(s): SLAYBACK PHARMA LLC (Princeton, NJ)The present invention provides stable pharmaceutical compositions, comprising a pharmaceutically effective amount of testosterone or a pharmaceutically acceptable ester thereof, a pharmaceutically acceptable oil vehicle, and a stabilizing amount of benzyl alcohol, for example, about 1% to 3% weight/volume of benzyl alcohol. The present invention also provides a process for stabilizing testosterone-containing pharmaceutical compositions by ageing them at a temperature of about 20° C. to about 60° C. for at least 48 hours, e.g., prior to secondary packing and labeling. These compositions were stable over the shelf life of the product, without exhibiting crystal formation, even upon storing at temperatures of about 2° C. to about 8° C. Other aspects of the invention relate to methods for making such pharmaceutical compositions, as well as methods of using such pharmaceutical compositions for hormone replacement therapy, e.g., in a male patient having a condition associated with symptoms of deficiency or absence of endogenous testosterone.
Patent expiration dates:
- March 25, 2039✓
- March 25, 2039
-
Pharmaceutical compositions of testosterone
Patent 12,138,271
Issued: November 12, 2024
Inventor(s): Soni; Umangi K. et al.
Assignee(s): SLAYBACK PHARMA LLC (Princeton, NJ)Stable pharmaceutical compositions are provided, comprising a pharmaceutically effective amount of testosterone or a pharmaceutically acceptable ester thereof, a pharmaceutically acceptable oil vehicle, and a stabilizing amount of benzyl alcohol, for example, about 1% to 3% weight/volume of benzyl alcohol. The present invention also provides a process for stabilizing testosterone-containing pharmaceutical compositions by ageing them at a temperature of about 20° C. to about 60° C. for at least 48 hours, e.g., prior to secondary packing and labeling. These compositions were stable over the shelf life of the product, without exhibiting crystal formation, even upon storing at temperatures of about 2° C. to about 8° C. Other aspects of the invention relate to methods for making such pharmaceutical compositions and methods of using such pharmaceutical compositions for hormone replacement therapy, e.g., in a male patient having a condition associated with symptoms of deficiency or absence of endogenous testosterone.
Patent expiration dates:
- March 25, 2039✓
- March 25, 2039
More about Azmiro (testosterone)
- Check interactions
- Compare alternatives
- Latest FDA alerts (7)
- Side effects
- Dosage information
- During pregnancy
- Drug class: androgens and anabolic steroids
- Breastfeeding
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Glossary
Term | Definition |
---|---|
Drug Patent | A 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 Exclusivity | Exclusivity 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. |
RLD | A 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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.