Details for New Drug Application (NDA): 021717

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NDA 021717 describes PLIAGLIS, which is a drug marketed by Crescita Therap and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the PLIAGLIS profile page.

The generic ingredient in PLIAGLIS is lidocaine; tetracaine. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lidocaine; tetracaine profile page.

Summary for 021717

Tradename:	PLIAGLIS
Applicant:	Crescita Therap
Ingredient:	lidocaine; tetracaine
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 021717

Generic Entry Date for 021717^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 10,603,293 Dosage: CREAM;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 021717

Physiological Effect	Local Anesthesia

Suppliers and Packaging for NDA: 021717

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717	NDA	Taro Pharmaceuticals U.S.A., Inc.	51672-5305	51672-5305-2	1 TUBE in 1 CARTON (51672-5305-2) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	7%;7%
Approval Date:	Jun 29, 2006	TE:		RLD:	Yes
Patent:	10,350,180	Patent Expiration:	Jan 14, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,603,293	Patent Expiration:	Jan 14, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,751,305	Patent Expiration:	Jan 14, 2031	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021717

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006	5,919,479	⤷ Subscribe
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006	6,528,086	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.