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Last Updated: March 21, 2023

Regulatory Exclusivity: NEW DOSING SCHEDULE

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Drugs with New Dosing Schedule Regulatory Exclusivity

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Abbvie Inc	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	See Plans and Pricing	EIGHT-WEEK DOSING REGIMEN FOR THE TREATMENT OF GENOTYPES 1, 2, 3, 4, 5, AND 6, CHRONIC HEPATITIS C VIRUS INFECTION IN TREATMENT-NAIVE SUBJECTS WITH COMPENSATED CIRRHOSIS BASED ON THE RESULTS FROM THE EXPEDITION-8 STUDY
Abbvie Inc	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	See Plans and Pricing	EIGHT-WEEK DOSING REGIMEN FOR THE TREATMENT OF GENOTYPES 1, 2, 3, 4, 5, AND 6, CHRONIC HEPATITIS C VIRUS INFECTION IN TREATMENT-NAIVE SUBJECTS WITH COMPENSATED CIRRHOSIS BASED ON THE RESULTS FROM THE EXPEDITION-8 STUDY
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-001	Aug 28, 2019		RX	Yes	No	See Plans and Pricing	INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes	See Plans and Pricing	INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	See Plans and Pricing	INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

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