PLIAGLIS Drug Patent Profile

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When do Pliaglis patents expire, and when can generic versions of Pliaglis launch?

Pliaglis is a drug marketed by Crescita Therap and is included in one NDA. There are three patents protecting this drug.

This drug has seven patent family members in seven countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Pliaglis

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 14, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for PLIAGLIS

International Patents:	7
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Clinical Trials:	10
Drug Prices:	Drug price information for PLIAGLIS
What excipients (inactive ingredients) are in PLIAGLIS?	PLIAGLIS excipients list
DailyMed Link:	PLIAGLIS at DailyMed

Drug patent expirations by year for PLIAGLIS

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

Generic Entry Date for PLIAGLIS^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 021717 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.

Recent Clinical Trials for PLIAGLIS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Cutia Therapeutics（Wuxi）Co.,Ltd	Phase 3
American Association of Endodontists	Phase 4
University of Michigan	Phase 4

See all PLIAGLIS clinical trials

Pharmacology for PLIAGLIS

Drug Class	Amide Local Anesthetic Antiarrhythmic Ester Local Anesthetic
Physiological Effect	Local Anesthesia

US Patents and Regulatory Information for PLIAGLIS

PLIAGLIS is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PLIAGLIS is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting PLIAGLIS

Solid-forming local anesthetic formulations for pain control
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Solid-forming topical formulations for pain control
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for PLIAGLIS

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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	⤷ 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

International Patents for PLIAGLIS

When does loss-of-exclusivity occur for PLIAGLIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 11205730
Patent: Solid-forming local anesthetic formulations for pain control
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2012017554
Patent: formulações de anestésicas locais formadoras de sólido para controle da dor
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 22220
Patent: FORMULATIONS POUR ANESTHESIE LOCALE SE SOLIDIFIANT POUR LA GESTION DE LA DOULEUR (SOLID-FORMING LOCAL ANESTHETIC FORMULATIONS FOR PAIN CONTROL)
Estimated Expiration: ⤷ Sign Up

China

Patent: 2834096
Patent: Solid-forming local anesthetic formulations for pain control
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 23660
Patent: FORMULATIONS POUR ANESTHÉSIE LOCALE SE SOLIDIFIANT POUR LA GESTION DE LA DOULEUR (SOLID-FORMING LOCAL ANESTHETIC FORMULATIONS FOR PAIN CONTROL)
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 12008168
Patent: FORMULACIONES ANESTESICAS LOCALES QUE FORMAN SOLIDOS PARA CONTROL DEL DOLOR. (SOLID-FORMING LOCAL ANESTHETIC FORMULATIONS FOR PAIN CONTROL.)
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PLIAGLIS around the world.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1401408		⤷ Sign Up
European Patent Office	0857047	Composition contentant un mélange éutectique de tetracaine et lidocaïne (Formulation comprising eutectic mixture of tetracaine and lidocaine)	⤷ Sign Up
Japan	2007083091	APPARATUS FOR ADMINISTRATION OF TRANSDERMAL PHARMACEUTICALS	⤷ Sign Up
European Patent Office	2523660	FORMULATIONS POUR ANESTHÉSIE LOCALE SE SOLIDIFIANT POUR LA GESTION DE LA DOULEUR (SOLID-FORMING LOCAL ANESTHETIC FORMULATIONS FOR PAIN CONTROL)	⤷ Sign Up
Australia	7719800		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration