The report provides a detailed analysis essential for establishing a doravirine production plant. It encompasses all critical aspects necessary for doravirine production, including the cost of doravirine production, doravirine plant cost, doravirine production costs, and the overall doravirine production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a doravirine production plant. These encompass production processes, raw material requirements, utility requirements, infrastructure needs, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, and more.
Doravirine is an antiviral drug that is mainly used in the pharmaceutical and healthcare industries for the treatment of HIV infection. It belongs to a class of medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which help prevent the virus from multiplying in the body. It is primarily utilised as part of antiretroviral therapy to help control the human immunodeficiency virus and improve the immune system function in patients. It is commonly used as part of combination therapy and is available in both standalone and fixed-dose formulations with other antiretroviral agents. It finds its main application in combination drug regimens used for managing HIV-1 in adults, which helps to reduce viral load and slow the progression of the disease. It is especially useful for patients starting HIV treatment for the first time or those switching from other regimens due to resistance or intolerance.
The demand for doravirine is predominantly driven by its application as an antiretroviral drug in the treatment of HIV-1 infection in adults and children, which strengthens its market growth. Its usage in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history also boosts its demand in the pharmaceutical industry. Its demand for having fewer drug interactions and a favourable side effect profile compared to some older HIV drugs significantly promotes its market growth. Its application as a prescription medicine in long-term HIV treatment programs to support better patient outcomes and quality of life also supports its demand in the healthcare sector.
Its involvement in modern antiviral research and therapy approaches associated with improving HIV care and reducing drug resistance also adds to its demand in the medical and pharmaceutical research industries. Growing awareness about early HIV treatment, rising infection rates in developing regions, and supportive public health initiatives further enhance its market potential. Additionally, production efficiencies, supplier consistency, environmental safety norms, and secure distribution systems play an important role in shaping its worldwide procurement and supply dynamics. Industrial doravirine procurement also depends on factors such as the cost and availability of active pharmaceutical ingredients (APIs), compliance with regulatory requirements, patent protection, and global drug approval pathways.
Raw Material for Doravirine Production
According to the doravirine production plant project report, the major raw materials for doravirine production include iodochlorobenzene, pyridine, copper cyanide, and chloromethyl triazolone.
Production Process of Doravirine
The extensive doravirine production cost report consists of the following industrial production process:
- Production via Chemical Synthesis: The production process of doravirine begins with the conversion of iodochlorobenzene as the starting material into a phenol intermediate using an iridium-catalysed borylation–oxidation step. Then, this phenol intermediate is coupled with a substituted pyridine through a nucleophilic aromatic substitution reaction to form a diaryl ether structure. The diaryl ether further undergoes hydrolysis and recrystallisation to obtain the main pyridinol intermediate. Then, a nitrile group is introduced using copper cyanide under carefully controlled conditions to avoid unwanted by-products and produce a mononitrile intermediate. The resulting compound is then alkylated with a chloromethyl triazolone reagent to build the core pyridone framework of doravirine. In the final step, selective methylation is carried out under mild conditions to produce doravirine as the active antiviral drug.
Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor (NNRTI) that appears as a white to off-white solid in powder form. The molecular formula of the compound is C17H11ClF3N5O3, and its molar mass is 425.75 g/mol. Its density is approximately 1.56 g/cm³, and it is practically insoluble in water but slightly soluble in dimethyl sulfoxide (DMSO) and methanol upon heating. The compound decomposes at temperatures above 278 °C, and it has a pKa value of 8.04. Doravirine is marketed under the brand name Pifeltro. It is administered orally as a 100 mg film-coated tablet, once daily, with or without food, and exhibits an oral bioavailability of approximately 64%. The compound is classified as a skin and eye irritant, and it is recommended to handle it with appropriate protective equipment and store it at -20 °C. The most common adverse reactions reported in clinical use include nausea, dizziness, headache, fatigue, diarrhoea, abdominal pain, and abnormal dreams.