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Last Updated: March 21, 2023

Regulatory Exclusivity Expiring in 2028

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Drugs with Regulatory Exclusivity Expiring in 2028

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-001	Jun 10, 2021		RX	Yes	No	See Plans and Pricing	PEDIATRIC EXCLUSIVITY
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-002	Jun 10, 2021		RX	Yes	Yes	See Plans and Pricing	PEDIATRIC EXCLUSIVITY
Abbvie Inc	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	See Plans and Pricing	PEDIATRIC EXCLUSIVITY
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No	See Plans and Pricing	PEDIATRIC EXCLUSIVITY
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	See Plans and Pricing	PEDIATRIC EXCLUSIVITY
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

Colorcon

Johnson and Johnson

Boehringer Ingelheim

McKesson

Dow

Harvard Business School

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