1. The Orphan Drug Act of 1983 97–414 97th Cong(1983).
2. Orphan Medicinal Products Regulation (EC) No.141/2000 of the European Parliament and of the Council December 16 1999. Official Journal L 018 January 22 2000. Accessed November 16 2023.https://eur‐lex.europa.eu/legal‐content/EN/TXT/PDF/?uri=CELEX:32000R0141&from=EN
3. The Generating Antibiotic Incentives Now (GAIN) Act Public Law112–144(2012).
4. Section 526 of the Federal Food Drug and Cosmetic Act 21 U.S.C. § 360bb(1983).
5. Orphan drugs in the United States: an examination of patents and orphan drug exclusivity.National Organization for Rare Disorders. March 25 2021. Accessed November 16 2023.https://rarediseases.org/wp‐content/uploads/2021/03/NORD‐Avalere‐Report‐2021_FNL‐1.pdf