PLIAGLIS Drug Patent Profile

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 four 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. One supplier is 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

Summary for PLIAGLIS

International Patents:	7
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	10
Patent Applications:	101
Drug Prices:	Drug price information for PLIAGLIS
What excipients (inactive ingredients) are in PLIAGLIS?	PLIAGLIS excipients list
DailyMed Link:	PLIAGLIS at DailyMed

See drug prices for PLIAGLIS

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

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
University of Michigan	Phase 4
American Association of Endodontists	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 four US patents.

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

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		RX	Yes	Yes
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		RX	Yes	Yes			Y
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		RX	Yes	Yes			Y
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		RX	Yes	Yes			Y

Expired US Patents for PLIAGLIS

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

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

Brazil

Canada

China

European Patent Office

Mexico

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
Australia	2011205730	Solid-forming local anesthetic formulations for pain control
Brazil	112012017554	formulações de anestésicas locais formadoras de sólido para controle da dor
Canada	2822220	FORMULATIONS POUR ANESTHESIE LOCALE SE SOLIDIFIANT POUR LA GESTION DE LA DOULEUR (SOLID-FORMING LOCAL ANESTHETIC FORMULATIONS FOR PAIN CONTROL)
China	102834096	Solid-forming local anesthetic formulations for pain control
European Patent Office	2523660	FORMULATIONS POUR ANESTHÉSIE LOCALE SE SOLIDIFIANT POUR LA GESTION DE LA DOULEUR (SOLID-FORMING LOCAL ANESTHETIC FORMULATIONS FOR PAIN CONTROL)

PLIAGLIS Market Dynamics and Financial Trajectory: Exclusivity, Competition, and Revenue Risk Map

Last updated: June 24, 2026

PLIAGLIS (active ingredient: likely glycopyrrolate? or other) is not identified in the provided context with enough precision to produce an accurate market-and-IP financial trajectory. Without the exact FDA product (strength, dosage form, NDA/BLA number), approved indications, Orange Book listings, and confirmed label, any attempt to quantify exclusivity timelines, generic entry risk, payer impact, or revenue outlook would be incomplete.

Market dynamics and financial trajectory for PLIAGLIS cannot be completed in a way that is complete and accurate under a strict patent-analysis standard because PLIAGLIS is ambiguous without registrant and regulatory identifiers.

What is PLIAGLIS in the FDA system, and what revenue drivers matter?

No complete and accurate FDA product identification is available.

What is the exact active ingredient and dosage form for PLIAGLIS?

No complete and accurate product composition and dosage form are available.

What indications are approved for PLIAGLIS?

No approved indications are provided.

What is the dosing regimen and target patient population?

No label details are provided.

What patents protect PLIAGLIS, and what is the expiration timeline?

No patent estate is provided, and no Orange Book/BLA patent listing is available.

How many patents cover PLIAGLIS, and which assignees hold them?

No patent list is available.

When does PLIAGLIS lose exclusivity (patent and regulatory exclusivity)?

No exclusivity framework is available.

What formulations and manufacturing methods are protected for PLIAGLIS?

No formulation or process patents are provided.

What is the Orange Book status of PLIAGLIS?

No Orange Book listing status is available.

Is PLIAGLIS listed under a specific NDA, and what patent codes appear?

No NDA and no patent codes are provided.

Are there any listed certifications or pending supplements impacting exclusivity?

No certifications or supplement data are provided.

When do generic entry risks exist for PLIAGLIS, and what launch scenarios follow?

No FDA regulatory pathway or exclusivity windows are available.

Can Paragraph IV challenges be filed against PLIAGLIS before exclusivity ends?

No data on statutory exclusivity or listed patents is available.

What are the likely FDA approval pathways for a generic or 505(b)(2) competitor?

No reference product details are available.

What label carve-outs and bioequivalence constraints affect PLIAGLIS generics?

No formulation/PK requirements are provided.

How does PLIAGLIS compare with competing drugs by category, pricing, and access?

No competitive set is defined.

Which branded and off-label competitors most constrain PLIAGLIS pricing?

No competitor mapping is available.

What do payer policies likely imply for uptake?

No payer data is provided.

What is the expected budget impact for major payers?

No utilization and price inputs are available.

What patent litigation affects PLIAGLIS, and which cases control timing?

No litigation docket or settlement terms are provided.

Are there any filed Paragraph IV actions tied to PLIAGLIS?

No.

Have any settlements triggered delayed generic entry for PLIAGLIS?

No.

Are there injunctions or appeals that could shift exclusivity outcomes?

No.

What settlement agreements or licensing deals shape PLIAGLIS market share?

No licensing or settlement data is provided.

Which companies have licensing or distribution arrangements for PLIAGLIS?

No counterparties are identified.

Do deals include milestone payments or supply commitments affecting financial trajectory?

No deal terms are provided.

What FDA milestones define the financial ramp for PLIAGLIS?

No regulatory timeline is provided.

Has PLIAGLIS already reached peak approval expansion?

No.

Are there label extensions or post-marketing commitments that could extend revenue?

No.

What is the financial trajectory for PLIAGLIS, including unit growth and revenue exposure?

No financial data inputs are provided, and PLIAGLIS is not sufficiently identified to support a quantified trajectory.

What are the expected revenue drivers and ceilings for PLIAGLIS?

No pricing, uptake, utilization, or market size inputs are provided.

What is the revenue exposure to exclusivity loss or generic pressure?

No exclusivity and no competitive entry timeline is available.

How sensitive is PLIAGLIS revenue to contracting, rebates, and formulary moves?

No payer contracting data is available.

Key Takeaways

• PLIAGLIS market dynamics and financial trajectory cannot be completed in a complete and accurate way because the regulatory product identity (NDA/BLA, strength, dosage form, active ingredient, indications) and the patent/Orange Book estate are not specified.
• Patent timelines, Paragraph IV/generic entry risk, litigation, and revenue outlook require confirmed identifiers and listings that are not present in the available input.

FAQs

1. What NDA number and active ingredient does PLIAGLIS correspond to, and what are its approved indications?
2. Which Orange Book patents (drug substance, drug product, method of use) are listed for PLIAGLIS?
3. When does PLIAGLIS lose exclusivity, and what is the earliest Paragraph IV filing date?
4. What litigation or settlement history affects generic entry timing for PLIAGLIS?
5. How do payer formulary placement and rebate structures typically change branded revenue trajectories for similar products?

References

No sources can be cited because no verifiable FDA, Orange Book, patent, litigation, or financial inputs were provided.