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Last Updated: May 7, 2024

Regulatory Exclusivity: MISCELLANEOUS

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Drugs with Miscellaneous Regulatory Exclusivity

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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	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No	⤷ Try a Trial	INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	⤷ Try a Trial	INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013		RX	Yes	No	⤷ Try a Trial	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-002	Feb 8, 2013		RX	Yes	No	⤷ Try a Trial	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013		RX	Yes	No	⤷ Try a Trial	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013		RX	Yes	Yes	⤷ Try a Trial	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012		RX	Yes	No	⤷ Try a Trial	ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

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