Combatting Antibiotic Resistance: Regulatory Exclusivities for New Antibiotic Development in the United States and Europe
| Autor: | Haijuan Wang, Vivek Reddy Murthannagari, Vaishnavi Parimala Thumpati, Ganesh GNK |
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| Jazyk: | angličtina |
| Rok vydání: | 2024 |
| Předmět: | |
| Zdroj: | Infectious Diseases & Immunity, Vol 4, Iss 2, Pp 79-85 (2024) |
| Druh dokumentu: | article |
| ISSN: | 2096-9511 2693-8839 00000000 |
| DOI: | 10.1097/ID9.0000000000000112 |
| Popis: | Abstract. Antimicrobial resistance is a global concern that has led to millions of deaths worldwide. Genetic changes occur naturally in pathogens such as viruses, bacteria, parasites, and fungi. To overcome these concerns, there is a need to develop a new generation of antimicrobials. In an effort to encourage innovation, both the United States (US) and the European Union have introduced exclusivity programs. The US offered 5 years of additional nonpatent exclusivity for Qualified Infectious Disease Products under the Generating Antibiotic Incentives Now Act. In parallel, the European Commission offers a patent extension of 12 months across Europe (EU) countries or the option to sell the vouchers to other pharmaceutical companies through transferable exclusivity extension vouchers. This review focuses on the most important innovative strategies of antibiotic development the drug approvals, their mode of action, spectra of activity, and targeting of microorganisms, in past 5 years were mentioned, and discusses how to overcome the challenges of drug approval under antibiotic exclusivity in the US and EU, which will benefit the companies to develop novel drugs in several nations. |
| Databáze: | Directory of Open Access Journals |
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