Table 2.

Overview of prevention strategies

Strategic options	Description	Exclusivity period	Source
Strategic patenting (“later issued patents”)	Obtaining patent protection on different aspects around the base compound patent	20 years from the date of filing	Hutchins (2003), Burdon and Sloper (2003)
Patent term restoration	Granting of additional market exclusivity for the time lost due to FDA approval process (Title II of Hatch–Waxman Act)	Maximum of 5 years	Agrawal and Thakkar (1997)
SPC	Protective mechanism serving as an extension to patent right	Maximum of 5 years	Hitchcock and Tugal (2003)
30-month stay provision	Filing a patent infringement suit to fight ANDA	30 months from the date of notice or till court decision	Bhat (2005)
Orphan drug	Applying for orphan drug status for an already authorized drug	7 years of market exclusivity in US, 10 years in EU	Haffner et al. (2008), Minghetti et al. (2000)
Pediatric exclusivity	Submission of pediatric clinical trials on the FDA’s request	6 months of market exclusivity	Kvesic (2008)
Patent settlement agreements	Involving in settlements with generic manufacturers to delay the market entry	Duration of the agreement	Bulow (2004)