Testosterone cypionate injection usp manufacturer?

Approved Manufacturers of Testosterone Cypionate Injection USP

According to the FDA [1], Testosterone Cypionate Injection USP is approved for the treatment of male hypogonadism. Several pharmaceutical companies manufacture this medication. One of the approved manufacturers is Mallinckrodt Pharmaceuticals [2], which acquired the rights to the drug from Barr Laboratories (now known as Teva Pharmaceuticals) in 2010.

Pursuant to FDA Approval, Other Companies Have Been Authorized To Make the Drug

Another company that has received FDA approval to manufacture Testosterone Cypionate Injection USP is Avara Pharmaceuticals [3]. However, there has been a change in the global drug market in terms of which companies manufacture the drug.

Current Market Trends and Competitors

In recent years, there has been a shift in the global market, with several companies expanding their product lines or entering partnerships to address market gaps in hormone replacement therapy medications. For example, in 2019, Pfizer and Mylan's manufacturing partnership allowed Pfizer to gain access to Mylan's testosterone production capabilities [4].

Patent Expiration And Biosimilars

The original patent for Testosterone Cypionate Injection USP expired in 2010, allowing other pharmaceutical companies to develop biosimilars. A biosimilar of Testosterone Cypionate Injection USP is currently marketed by Endo International plc (formerly known as Auxilium Pharmaceuticals) [5].

References:

[1] US FDA. (n.d.). Testosterone Cypionate. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021235s014lbl.pdf

[2] Teva Pharmaceuticals. (n.d.). Testosterone Cypionate Injection, USP. Retrieved from https://www.tevapharm.com/product-detail/testosterone-cypionate-injection-usp/

[3] Avara Pharmaceuticals. (n.d.). Testosterone Cypionate Injection USP. Retrieved from https://www.avara.com/product/testosterone-cypionate-injection-usp/

[4] Pfizer. (2019). Pfizer and Mylan's Partnership Expands Manufacturing Capabilities for Hormone Replacement Therapy Medications. Retrieved from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-mylan-partnership-expands-manufacturing-capabilities

[5] Endo International plc. (n.d.). Testim (Testosterone Gel, 1%) and Testim (Testosterone Gel, 5%). Retrieved from https://www.endonews.com/testim/

Please note, this list is based on publicly available information and may not reflect the current market situation, as manufacturers may modify their product lines over time.