DrugPatentWatch Alpha Signals Regulatory Exclusivity

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Regulatory Exclusivity: New Dosing Schedule

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Drugs with New Dosing Schedule Regulatory Exclusivity

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Abbvie	VUITY	pilocarpine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	214028-001	Oct 28, 2021	AB	RX	Yes	Yes		ADDITION OF SECOND DOSE FOR TREATMENT OF PRESBYOPIA IN ADULTS
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes		ADDITION OF A ONCE DAILY DOSING REGIMEN
Ucb Inc	VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008	AP	RX	Yes	Yes		USE OF ALTERNATE INITIAL DOSING REGIMEN FOR INITIATION OF LACOSAMIDE TREATMENT IN PARTIAL ONSET SEIZURE PATIENTS ≥1 MONTH TO
Ucb Inc	VIMPAT	lacosamide	SOLUTION;ORAL	022255-001	Apr 20, 2010	AA	RX	Yes	Yes		USE OF ALTERNATE INITIAL DOSING REGIMEN FOR INITIATION OF LACOSAMIDE TREATMENT IN PARTIAL ONSET SEIZURE PATIENTS ≥1 MONTH TO

Regulatory Exclusivity

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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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