Liposomal Doxorubicin Market: The new manufacturer approvals by the U.S. FDA for Doxil in 2015

Posted On May, 22, 2023

Janssen Products, LP received the U.S. FDA approval in 1995 for Doxil, a liposomal doxorubicin formulation to treat Kaposi’s sarcoma, multiple myeloma, breast, and ovarian cancer. The distribution and marketing of Doxil was done by a subsidiary of Johnson and Johnson (J&J), Janssen Products, LP, and was manufactured by Ben Venue Laboratories. However, there was limited availability of Doxil due to the production problems with third-party manufacturer in 2011.

Janssen Products, LP had been receiving its drug supply from Ben Venue Laboratories, a unit of Boehringer Ingelheim GmbH in Germany, however, due to quality control issues, the Ben Venue Laboratories shut its manufacturing units in 2011. In 2012, the U.S. FDA approved temporary drug import to deal with the drug shortage problem. Sun Pharma Global, a subsidiary of Sun Pharmaceuticals Industries Ltd. received temporary supply of Lipodox in U.S.

In 2013, the generic version of this anticancer drug was approved from the U.S. FDA for manufacturing, distribution, and marketing Doxil. In 2015, the U.S. FDA approved new manufacturers for Doxil for the U.S. market. In April 2016, it was announced that NICE recommended PEGylated liposomal doxorubicin hydrochloride for treating recurrent ovarian cancer.

Some of the brand names for liposomal doxorubicin in the U.S. market are Doxil, Lipodox 50, and Lipodox [DSC]. In 2015, the global liposomal doxorubicin market was valued at USD 814.6 million and is expected to grow at a CAGR of 6.4% over the forecast period. The growing number of players and the growing demand of the drug for treatment of various conditions such as breast, ovary, liver, kidney carcinomas, as well as multiple myeloma are amongst some factors expected to drive the market in the coming few years. Some of the Contract Development and Manufacturing Organizations (CDMO) for this drug are Azaya Therapeutics Incorporated; Merrimack Pharmaceuticals, Inc.; CORDENPHARMA; and many others.

In 2015, J&J (Doxil/Caelyx) accounted for the majority of the revenue share owing the growing demand for the branded version of the drug in the U.S. market, which accounts for almost 43.4% revenue share. The presence of approval for import of generic version of Doxil in the U.S. market and constant shortage of its production are among few factors expected to drive the demand for Lipodox in the coming years.

In-depth report on global liposomal doxorubicin market by Grand View Research:


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