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Hepatitis C is a burgeoning disease that is still in search of a one-drug-fits-all solution. Currently, each hepatitis C virus genotype is treated with a pharmaceutical cocktail that consists of a mixture of antivirals, most of whose names end with 鈥渧ir鈥�.
Sofosbuvir is one such compound. It was discovered in 2007 by Michael Sofia at Pharmasset (now part of Gilead Sciences) and approved for use in the United States by the Food and Drug Administration in 2013. The FDA approval was for the combination of sofosbuvir and ribavirin, an antiviral that dates back to 1972. Sofosbuvir is the active ingredient in Gilead鈥檚 products Sovaldi and Harvoni, ads for which you may have seen on TV.
Sofosbuvir was the subject of a high-profile patent lawsuit involving Gilead and drug giant Merck. Merck contended that sofosbuvir was patterned after a patent awarded to Idenix Pharmaceuticals, a company that Merck had acquired. After a series of trials, a federal jury ordered Gilead to pay Merck US$2.54 billion (that鈥檚 right, billion) for infringing the Idenix patent.
Gilead appealed; and this past February, the judge in a US district court , writing that the Idenix patent was too broad and that a skilled chemist could not easily derive sofosbuvir from the information in the patent. For the same reason, the judge invalidated the patent.
Merck has vowed to appeal the overturn ruling.听
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Sofosbuvir hazard information
GHS classification*: skin irritation, category 2听 听听 | |
H315鈥擟auses skin irritation听 | ![]() |
GHS classification: skin sensitization, category 1 | |
H317鈥擬ay cause an allergic skin reaction | ![]() |
GHS classification: serious eye damage, category 1 | |
H318鈥擟auses serious eye damage听 | ![]() |
GHS classification: respiratory sensitisation, category 1 | |
H334鈥擬ay cause allergy or asthma symptoms or breathing difficulties if inhaled | ![]() |
GHS classification: specific target organ toxicity, single exposure, respiratory tract irritation, category3 | |
H335鈥擬ay cause respiratory irritation | ![]() |
GHS classification: germ cell mutagenicity, category 2 | |
H341鈥擲uspected of causing genetic defects | ![]() |
GHS classification: reproductive toxicity, category 2 | |
H361鈥擲uspected of damaging fertility or the unborn child | ![]() |
GHS classification: specific target organ toxicity, single exposure, category 1 | |
H370鈥擟auses damage to organs听 | ![]() |
GHS classification: hazardous to the aquatic environment, long-term hazard, category 4 | |
H413鈥擬ay cause long-lasting harmful effects to aquatic life | ![]() |
*Globally Harmonized System of Classification and Labeling of Chemicals.听.
Sofosbuvir听fast facts
CAS Reg. No. | 1190307-88-0 |
Molar mass | 529.46 g/mol |
Empirical formula | C22H29FN3O9P |
Appearance | White to off-white crystals or powder |
Melting point | 94鈥�125 潞C* |
Water solubility | 鈮�105 mg/L* |
*Depends on crystalline polymorph.
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