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-nine suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.
The generic ingredient in LATUDA is lurasidone hydrochloride. There are twenty-six drug master file entries for this compound. Twenty-nine 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 |
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: | 8,729,085*PED | Patent Expiration: | Nov 26, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 8,883,794*PED | Patent Expiration: | Nov 26, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 9,174,975*PED | Patent Expiration: | Aug 20, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 200603
| 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 | 5,532,372*PED | ⤷ Subscribe |
| Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-001 | Oct 28, 2010 | 5,532,372*PED | ⤷ Subscribe |
| Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-003 | Dec 7, 2011 | 5,532,372*PED | ⤷ Subscribe |
| Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-004 | Apr 26, 2012 | 5,532,372*PED | ⤷ Subscribe |
| Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-005 | Jul 12, 2013 | 9,815,827 | ⤷ Subscribe |
| Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-002 | Oct 28, 2010 | 9,174,975*PED | ⤷ Subscribe |
| Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-004 | Apr 26, 2012 | 9,815,827 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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