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Last Updated: November 4, 2024

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 three suppliers. 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. Three suppliers are 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*:
Constraining patent/regulatory exclusivity:
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 EffectLocal 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
PLIAGLIS lidocaine; tetracaine CREAM;TOPICAL 021717 NDA AUTHORIZED GENERIC Innovida Pharmaceutique Corporation 71800-631 71800-631-04 4 TUBE in 1 CARTON (71800-631-04) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength7%;7%
Approval Date:Jun 29, 2006TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 14, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jan 14, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jan 14, 2031Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021717

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Crescita Therap PLIAGLIS lidocaine; tetracaine CREAM;TOPICAL 021717-001 Jun 29, 2006 ⤷  Sign Up ⤷  Sign Up
Crescita Therap PLIAGLIS lidocaine; tetracaine CREAM;TOPICAL 021717-001 Jun 29, 2006 ⤷  Sign Up ⤷  Sign Up
>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.