DrugPatentWatch Alpha Signals Regulatory Exclusivity

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Drug Search Regulatory Exclusivity

Regulatory Exclusivity: New Patient Population

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Drugs with New Patient Population Regulatory Exclusivity

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No	⤷ Get Started Free	NEW PATIENT POPULATION
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013		RX	Yes	Yes	⤷ Get Started Free	NEW PATIENT POPULATION
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-001	Feb 16, 2018		RX	Yes	No	⤷ Get Started Free	NEW PATIENT POPULATION
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-002	Feb 16, 2018		RX	Yes	No	⤷ Get Started Free	NEW PATIENT POPULATION
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

Regulatory Exclusivity

Search by exclusivity type:

Competitive Generic Therapy
New Chemical Entity
New Dosing Schedule
New Indication
New Product
New Patient Population
New Strength
Orphan Drug
Patent Challenge
Pediatric Exclusivity
RX to OTC Switch

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