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Last Updated: April 18, 2021

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PLIAGLIS Drug 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 six patent family members in six 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:6
US Patents:3
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:

*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

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

See all PLIAGLIS clinical trials

Pharmacology for PLIAGLIS

US Patents and Regulatory Information for PLIAGLIS

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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson

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