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Last Updated: March 26, 2023

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
Pharmacyclics Inc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No	See Plans and Pricing	INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB
Pharmacyclics Inc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013		RX	Yes	Yes	See Plans and Pricing	INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-001	Feb 16, 2018		RX	Yes	No	See Plans and Pricing	INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-002	Feb 16, 2018		RX	Yes	No	See Plans and Pricing	INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	No	See Plans and Pricing	INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-004	Feb 16, 2018		RX	Yes	Yes	See Plans and Pricing	INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		DISCN	Yes	No	See Plans and Pricing	INFORMATION ADDED TO LABELING REGARDING A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE CARDIOVASCULAR OUTCOMES AFTER TREATMENT WITH EXENATIDE ONCE WEEKLY IN PATIENTS WITH TYPE 2 DIABETES MELLITES
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

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