Details for New Drug Application (NDA): 200603

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NDA 200603 describes LATUDA, which is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LATUDA profile page.

The generic ingredient in LATUDA is lurasidone hydrochloride. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.

Summary for 200603

Tradename:	LATUDA
Applicant:	Sunovion Pharms Inc
Ingredient:	lurasidone hydrochloride
Patents:	9

Pharmacology for NDA: 200603

Medical Subject Heading (MeSH) Categories for 200603

Adrenergic alpha-2 Receptor Antagonists
Antipsychotic Agents
Dopamine D2 Receptor Antagonists
Serotonin 5-HT2 Receptor Antagonists

Suppliers and Packaging for NDA: 200603

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603	NDA	Sumitomo Pharma America, Inc.	63402-302	63402-302-04	4 BLISTER PACK in 1 CARTON (63402-302-04) / 7 TABLET, FILM COATED in 1 BLISTER PACK (63402-302-07)
LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603	NDA	Sumitomo Pharma America, Inc.	63402-302	63402-302-10	10 BLISTER PACK in 1 CARTON (63402-302-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63402-302-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Oct 28, 2010	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 26, 2026	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Nov 26, 2026	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Aug 20, 2024	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 200603

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013	⤷ Sign Up	⤷ Sign Up
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-001	Oct 28, 2010	⤷ Sign Up	⤷ Sign Up
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-003	Dec 7, 2011	⤷ Sign Up	⤷ Sign Up
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-002	Oct 28, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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