Chronic hepatitis (CHC), viral polymerase nucleotide inhibitor & Process patents review and evaluation preparation of Sofosbuvir
Article Sidebar
-
HCV, Sofosbuvir, ICH Q6A, WHO,USFDA, Patent Cooperation Treaty (PCT)
Abstract
Sofosbuvir is a viral polymerase nucleotide inhibitor that was approved in December 2013 by the United States Food and Drug Administration (FDA), and in January 2014 by the European Medicines Agency for the treatment of HCV infection1. The WHO Guidelines for the screening, care and treatment of persons with hepatitis C infection recommend sofosbuvir in combination with ribavirin in genotypes 1, 2, 3 and 4 HCV infection, either with or without pegylated interferon (depending on the HCV genotype)7. Sofosbuvir in combination with ribavirin is the first interferon-free HCV treatment. The fact that sofosbuvir is all oral simplifies the treatment and will allow expansion in low resource settings with poor health infrastructure.
- The objective of this paper identify the most relevant process patents with respect to the medicines
- identify in which countries these patents have been filed and granted
This Article study mainly find numerous patents relating to preparation of Sofosbuvir. These patents will cover different aspects and innovations around the same product. Not all however are equally relevant, as many will cover variations or production processes but would not prevent somebody else to produce the medicine, e.g. by using a different process.
Full text article
References
2. Patent US 7,964,580.
3. Patent US 8,735,569
4. Patent WO2011123668A2
5. Patent WO2012012465A1
6. Patent US8618076B2
7. Statement on a Nonproprietary Name Adopted by the USAN Council. Available from: http://www-ama-assn-org/resources/doc/usan/nabiximols.pdf .
8. Lam AM, Espiritu C, Bansal S, MicolochickSteuer HM, Niu C, Zennou V, et al. Genotype and subtype pro-ling of PSI-7977 as a nucleotide inhibitor of hepatitis C virus. Antimicrob Agents Chemother. 2012;56:3359–68. [PMC free article] [PubMed]
9. Murakami E, Tolstykh T, Bao H, Niu C, Steuer HM, Bao D, et al. Mechanism of activation of PSI-7851 and its diastereoisomer PSI-7977. J Biol Chem. 2010;285:34337–47. [PMC free article] [PubMed] [Google Scholar]
10. Drug Interactions with Investigational Hepatitis C Nucleotide Inhibitors. Sofosbuvir. [Last accessed on 2013 Sep 28]. Available from: http://www.hcvdruginfo.ca/downloads/Hepatitis%20C-int_new%20nucleotide%20inhibitors.pdf .
11. An Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination in subjects with nosocomial genotype 1 HCV infection. [Last accessed on 2013 Nov 11]. Available from: http://clinicaltrials.gov/ct2/show/NCT01924949 .
12. Stepanova M, Nader F, Cure S, Bourhis F, Hunt S, Younossi ZM. Patients' preferences and health utility assessment with SF-6D and EQ-5D in patients with chronic hepatitis C treated with sofosbuvir regimens. Aliment Pharmacol Ther. 2014 Sep;40(6):676-85. doi: 10.1111/apt.12880. Epub 2014 Jul 15.
13. Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, Schultz M, Davis MN, Kayali Z, Reddy KR, Jacobson IM, Kowdley KV, Nyberg L, Subramanian GM, Hyland RH, Arterburn S, Jiang D, McNally J, Brainard D, Symonds WT, McHutchison JG, Sheikh AM, Younossi Z, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 May 16;368(20):1878-87. doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23.