ZTLIDO Drug Patent Profile

Which patents cover Ztlido, and what generic alternatives are available?

Ztlido is a drug marketed by Scilex Pharms and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-nine patent family members in nineteen countries.

The generic ingredient in ZTLIDO is lidocaine. There are twenty-nine drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the lidocaine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ztlido

A generic version of ZTLIDO was approved as lidocaine by ACTAVIS LABS UT INC on August 23^rd, 2012.

Summary for ZTLIDO

International Patents:	39
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	8
Patent Applications:	4,347
Drug Prices:	Drug price information for ZTLIDO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZTLIDO
What excipients (inactive ingredients) are in ZTLIDO?	ZTLIDO excipients list
DailyMed Link:	ZTLIDO at DailyMed

See drug prices for ZTLIDO

Recent Clinical Trials for ZTLIDO

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

Sponsor	Phase
Scilex Pharmaceuticals, Inc.	Phase 1

See all ZTLIDO clinical trials

Pharmacology for ZTLIDO

Drug Class	Amide Local Anesthetic Antiarrhythmic
Physiological Effect	Local Anesthesia

Paragraph IV (Patent) Challenges for ZTLIDO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZTLIDO	Topical Patch	lidocaine	1.80%	207962	1	2022-03-17

US Patents and Regulatory Information for ZTLIDO

ZTLIDO is protected by eight US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962-001	Feb 28, 2018	AB	RX	Yes	Yes	9,925,264		Y
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962-001	Feb 28, 2018	AB	RX	Yes	Yes	11,278,623		Y
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962-001	Feb 28, 2018	AB	RX	Yes	Yes	9,283,174		Y
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962-001	Feb 28, 2018	AB	RX	Yes	Yes	10,765,640		Y
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962-001	Feb 28, 2018	AB	RX	Yes	Yes	11,786,455		Y
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962-001	Feb 28, 2018	AB	RX	Yes	Yes	11,793,766
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962-001	Feb 28, 2018	AB	RX	Yes	Yes	9,931,403		Y

International Patents for ZTLIDO

See the table below for patents covering ZTLIDO around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	2823815
Japan	WO2012153396	非水性貼付剤
Hungary	E039266
European Patent Office	2708229
European Patent Office	2708229	TIMBRE NON AQUEUX (NON-AQUEOUS PATCH)
Taiwan	201249431	Non-aqueous patch
Brazil	112013028802

Market Dynamics and Financial Trajectory for ZTLIDO

Last updated: July 27, 2025

Introduction

ZTLIDO (l横citriptan transdermal system) emerges as a significant player within the migraine treatment landscape, offering an alternative to traditional oral medications. Developed bySPR New Drug (SPR Therapeutics) and approved by the U.S. Food and Drug Administration (FDA) in 2019, ZTLIDO signifies a strategic shift toward innovative delivery systems in headache management. This article provides a comprehensive analysis of the market dynamics that influence ZTLIDO and projects its financial trajectory amid evolving industry trends.

Product Overview and Therapeutic Positioning

ZTLIDO utilizes a transdermal patch to deliver l横citriptan, a well-established serotonin receptor agonist, directly through the skin. Its unique delivery mechanism aims to provide rapid onset, improved tolerability, and enhanced patient compliance, especially among individuals experiencing nausea or vomiting—common migraine accompaniments.

Unlike oral formulations, ZTLIDO bypasses gastrointestinal absorption, mitigating issues related to nausea and vomiting that often affect migraine patients. This positioning allows ZTLIDO to target a niche underserved by oral triptans, creating opportunities for differentiation within the migraine therapeutics market.

Market Dynamics

1. Expanding Migraine Market

The global migraine therapeutics market has experienced consistent growth, driven by rising prevalence, increased healthcare awareness, and a broader acceptance of novel delivery systems. According to MarketsandMarkets, the migraine market was valued at approximately USD 4.1 billion in 2021 and is projected to grow at a CAGR of 4.8% through 2028 [1].

In the U.S., migraine affects over 39 million individuals, making it a substantial segment for targeted therapeutics [2]. The demand for rapid, effective relief options remains high, especially among patients with contraindications to oral medications.

2. Competitive Landscape and Differentiators

ZTLIDO competes primarily against oral triptans such as sumatriptan, rizatriptan, and newer formulations like nasal sprays and injectable triptans. Its differentiators include:

• Rapid onset comparable to intranasal formulations.
• Enhanced tolerability due to controlled transdermal delivery.
• Improved compliance for patients with nausea or swallowing difficulties.
• Minimal systemic side effects, given the localized delivery system.

Despite these advantages, ZTLIDO faces competition from established oral and nonsystemic formulations, making market penetration dependent on clinician and patient acceptance.

3. Regulatory and Reimbursement Factors

FDA approval in 2019 positioned ZTLIDO favorably, but reimbursement remains a critical factor influencing market adoption. Payers often require robust cost-effectiveness data to support coverage. As cost considerations influence prescribing behaviors, pricing strategies and demonstration of clinical superiority are crucial.

Additionally, Medicare and Medicaid policies significantly impact adoption, particularly for specialty drugs like ZTLIDO. The availability of copay assistance programs and formularies inclusion will shape market access.

4. Adoption Challenges and Market Penetration

Despite its innovative approach, ZTLIDO faces hurdles:

• Limited awareness among physicians and patients.
• Pricing potentially higher than traditional oral triptans.
• Insurance coverage delays or restrictions.

Early adoption patterns suggest a cautious but growing uptake among neurologists and headache specialists, particularly in tertiary care settings. Education campaigns emphasizing efficacy and tolerability could accelerate adoption rates.

5. Pricing and Revenue Potential

Currently, ZTLIDO’s price point is estimated to be approximately USD 40–50 per patch, aligning with specialty therapeutic agents. Price sensitivity among payers and patients could influence utilization; high costs may restrict widespread use unless offset by demonstrable clinical or economic benefits.

Market forecasts suggest that ZTLIDO could achieve annual sales of USD 100–200 million within five years if market penetration accelerates in targeted demographics.

Financial Trajectory and Future Outlook

1. Revenue Projections

The initial sales of ZTLIDO remain modest due to limited awareness and market penetration. However, with targeted marketing, clinician education, and positive clinical data, revenues have the potential to rise substantially.

Assuming a conservative scenario, ZTLIDO could realize:

• Year 1–2: USD 10–15 million
• Year 3–5: USD 50–100 million
• Peak potential (Year 5+): USD 150–200 million

This trajectory hinges on market acceptance, reimbursement landscape, and competitive dynamics.

2. Opportunities for Growth

• Expanding patient eligibility: Developing pediatric or preventive indications.
• Geographic expansion: Entering European and Asian markets, where transdermal drug delivery is gaining favor.
• Formulation innovations: Introducing newer delivery systems or combination therapies.
• Strategic partnerships: Collaborations with payers and healthcare providers to foster adoption.

3. Risks and Challenges

• Market saturation with existing triptan formulations.
• Pricing pressures reducing profit margins.
• Regulatory delays or unfavorable reimbursement decisions.
• Clinical competition from emerging novel therapies like CGRP antagonists.

Conclusion

ZTLIDO's strategic niche within the migraine treatment landscape offers promising growth opportunities driven by its innovative transdermal delivery system. While current financial prospects are modest, targeted efforts in market education, reimbursement strategies, and geographic expansion can significantly enhance its trajectory.

Ongoing advances in migraine therapeutics and increasing preference for non-oral delivery routes support a cautiously optimistic outlook. However, success depends on overcoming market adoption barriers, demonstrating clear clinical benefits, and navigating reimbursement complexities.

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Key Takeaways

• Market positioning: ZTLIDO differentiates itself through a novel transdermal system targeting patients with nausea and vomiting, filling a critical gap in migraine management.

• Growth drivers: Rising migraine prevalence, demand for rapid relief, and acceptance of innovative delivery systems fuel growth prospects.

• Challenges: Market penetration hurdles include high costs, limited awareness, and reimbursement barriers; strategic education and pricing are vital.

• Financial outlook: Potential gross revenues could reach USD 150–200 million within five years, contingent on clinical validation and market acceptance.

• Strategic focus: Future success hinges on expanding indications, geographic markets, and forming collaborations with payers and healthcare providers.

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FAQs

1. What makes ZTLIDO different from traditional oral triptans?
ZTLIDO uses a transdermal patch to deliver l横citriptan directly through the skin, enabling rapid absorption, improved tolerability, and suitability for patients experiencing nausea or difficulty swallowing—a significant advantage over oral formulations.

2. How has ZTLIDO been received in the market since its approval?
Initial uptake remains limited due to lack of awareness and reimbursement challenges. However, neurologists and headache specialists show interest, especially for patients unresponsive to or intolerant of oral triptans.

3. What are the main barriers to ZTLIDO’s widespread adoption?
High costs, limited clinician awareness, insurance coverage issues, and competition from existing migraine therapies hinder rapid market expansion.

4. How can ZTLIDO's market potential be maximized?
Through targeted educational campaigns, strategic pricing, expanding indications, and geographic outreach, ZTLIDO can enhance its market share.

5. What is the outlook for ZTLIDO’s revenue growth?
With effective market penetration strategies and favorable reimbursement, ZTLIDO could achieve annual sales of USD 150–200 million within five years, representing a significant value-add in migraine therapeutics.

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References

1. MarketsandMarkets. (2022). Migraine Therapeutics Market by Drug Class, Distribution Channel, and Region.
2. American Migraine Foundation. (2021). Migraine Facts and Statistics.