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Last Updated: May 26, 2022

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 Taro Pharms 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: 2
Clinical Trials: 9
Formulation / Manufacturing:see details
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
Drug Prices for PLIAGLIS

See drug prices for PLIAGLIS

DrugPatentWatch® Estimated Generic Entry Opportunity Date for PLIAGLIS
Generic Entry Date for PLIAGLIS*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
American Association of EndodontistsPhase 4
University of MichiganPhase 4
Galderma Laboratories, L.P.Phase 4

See all PLIAGLIS clinical trials

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid-forming local anesthetic formulations for pain control
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid-forming topical formulations for pain control
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro Pharms PLIAGLIS lidocaine; tetracaine CREAM;TOPICAL 021717-001 Jun 29, 2006 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Taro Pharms PLIAGLIS lidocaine; tetracaine CREAM;TOPICAL 021717-001 Jun 29, 2006 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Taro Pharms PLIAGLIS lidocaine; tetracaine CREAM;TOPICAL 021717-001 Jun 29, 2006 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Taro Pharms PLIAGLIS lidocaine; tetracaine CREAM;TOPICAL 021717-001 Jun 29, 2006 See Plans and Pricing See Plans and Pricing
Taro Pharms PLIAGLIS lidocaine; tetracaine CREAM;TOPICAL 021717-001 Jun 29, 2006 See Plans and Pricing See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2012017554
Estimated Expiration: See Plans and Pricing

Canada

Patent: 22220
Estimated Expiration: See Plans and Pricing

China

Patent: 2834096
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 23660
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 12008168
Estimated Expiration: See Plans and Pricing

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.

Country Patent Number Title Estimated Expiration
Brazil 112012017554 formulações de anestésicas locais formadoras de sólido para controle da dor See Plans and Pricing
China 1589779 See Plans and Pricing
Japan 2012246315 DRUG DELIVERY OF PHASE CHANGING FORMULATION See Plans and Pricing
Australia 6638696 See Plans and Pricing
Japan 2006326337 CONTROLLED HEAT TO REGULATE TRANSDERMAL DELIVERY OF MEDICAL SUBSTANCE See Plans and Pricing
European Patent Office 1702597 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Colorcon
Baxter
Johnson and Johnson
McKinsey

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.