ZTLIDO Drug Patent Profile

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

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-eight 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:	38
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	132
Clinical Trials:	8
Patent Applications:	4,455
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		RX	Yes	Yes			Y
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962-001	Feb 28, 2018		RX	Yes	Yes			Y
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962-001	Feb 28, 2018		RX	Yes	Yes			Y
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962-001	Feb 28, 2018		RX	Yes	Yes			Y
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962-001	Feb 28, 2018		RX	Yes	Yes			Y

International Patents for ZTLIDO

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

Country	Patent Number	Title	Estimated Expiration
Brazil	122021017591	Uso de lidocaína para a preparação de um curativo adesivo não-aquoso para o tratamento de dor
Turkey	201810942
Spain	2845524
European Patent Office	2823815	PATCH NON AQUEUX (NON-AQUEOUS PATCH)
Mexico	349572	PARCHE NO ACUOSO. (NON-AQUEOUS PATCH.)

Market Dynamics and Financial Trajectory for ZTlido®

Introduction to ZTlido®

ZTlido®, a non-opioid pain management product developed by Scilex Holding Company, has been making significant waves in the pharmaceutical industry. This lidocaine patch is designed to treat both acute and chronic pain, particularly post-shingles nerve pain, also known as postherpetic neuralgia (PHN).

Market Context: Shift Away from Opioids

The healthcare industry is witnessing a profound shift towards non-opioid pain management solutions due to the increasing awareness of opioid addiction risks and stricter regulatory measures. This trend positions Scilex Holding Company favorably, as ZTlido® is recognized as a leading non-opioid branded pain treatment by pain specialists[4].

Recent Financial Performance

July 2024 Preliminary Results

In July 2024, Scilex Holding Company reported preliminary unaudited financial results that highlighted substantial growth in ZTlido® sales. The net sales for ZTlido® were estimated to be between $4.0 million and $5.0 million, representing a growth of approximately 48% to 85% compared to the same period in 2023. Total product net sales for the month ranged from $4.3 million to $5.3 million, indicating a growth of 54% to 89% year-over-year[1][3].

Q3 2024 Preliminary Results

For the quarter ended September 30, 2024, ZTlido® net sales were estimated to be between $11.0 million and $13.0 million, showing a growth of 9% to 29% compared to the same quarter in 2023. Total product net sales for the quarter were in the range of $12.0 million to $14.0 million, representing a growth of 19% to 39%[2].

Long-Term Growth Prospects

Historical Growth Trends

In June 2023, Scilex Holding Company reported record monthly revenue, with ZTlido® gross sales showing significant growth. For the quarter ended June 2023, ZTlido® gross sales ranged from $37.5 million to $39.0 million, a growth of 79% to 86% compared to the same quarter in 2022. Year-to-date sales up to June 2023 also showed robust growth, ranging from $64.2 million to $67.3 million, an increase of 63% to 71%[5].

Future Projections

According to market research conducted by Syneos Health Consulting, ZTlido® has peak sales potential projected to reach over $500 million in the next six years in the U.S. This projection is supported by increased awareness and substantial intent to utilize ZTlido® among healthcare providers[4].

Geographic Expansion

Scilex Holding Company is set to expand the distribution of ZTlido® outside the U.S. in 2025, with exclusive territory distributors in the Middle East and North/South Africa. This expansion comes with a $105 million minimum 5-year purchase commitment, further solidifying the product's global market presence[4].

Competitive Landscape

ZTlido® has been recognized as the most prescribed non-opioid branded pain treatment by pain specialists, according to Prescription Data from Symphony Health. This leadership position in the market is crucial as the company navigates a competitive pharmaceutical landscape[4].

Regulatory and Market Factors

The success of ZTlido® is also influenced by regulatory approvals and market dynamics. For instance, changes in insurance coverage, new product launches by competitors, and evolving pain management guidelines could impact future performance. However, the current trend towards non-opioid solutions and the product's FDA approval position it favorably[3].

Patient and Healthcare Provider Adoption

Increased awareness and adoption among healthcare providers are key drivers of ZTlido®'s growth. The product's efficacy and patient satisfaction data also play a crucial role in its market traction. As more healthcare providers become aware of and prescribe ZTlido®, the product is likely to continue its upward sales trajectory[4].

Financial Stability and Growth

Scilex Holding Company's financial stability is bolstered by the consistent growth in ZTlido® sales. The company's ability to generate revenue through its flagship product ensures a strong financial foundation, enabling further investment in research, development, and market expansion.

Key Takeaways

• Significant Sales Growth: ZTlido® has shown substantial growth in sales, with a 48% to 85% increase in July 2024 and a 9% to 29% growth in Q3 2024.
• Market Leadership: Recognized as the most prescribed non-opioid branded pain treatment by pain specialists.
• Geographic Expansion: Set to expand distribution outside the U.S. in 2025 with a significant purchase commitment.
• Long-Term Prospects: Projected to reach over $500 million in sales in the next six years in the U.S.
• Regulatory and Market Factors: Positioned favorably due to the shift away from opioids and regulatory approvals.

FAQs

What is ZTlido® used for?

ZTlido® is a non-opioid pain management product used to treat both acute and chronic pain, particularly post-shingles nerve pain (PHN).

How has ZTlido® performed financially in recent months?

In July 2024, ZTlido® net sales were estimated to be between $4.0 million and $5.0 million, representing a growth of 48% to 85% compared to the same period in 2023. For Q3 2024, net sales were estimated between $11.0 million and $13.0 million, showing a growth of 9% to 29%.

What are the long-term growth prospects for ZTlido®?

ZTlido® is projected to reach over $500 million in sales in the next six years in the U.S., according to market research by Syneos Health Consulting.

Is ZTlido® expanding its distribution globally?

Yes, ZTlido® is set to expand its distribution outside the U.S. in 2025, with exclusive territory distributors in the Middle East and North/South Africa, backed by a $105 million minimum 5-year purchase commitment.

How does ZTlido® compare to other pain management products in the market?

ZTlido® is recognized as the most prescribed non-opioid branded pain treatment by pain specialists, positioning it as a leader in the non-opioid pain management market.

Sources:

1. Scilex Holding Releases Preliminary Financial Results for July 2024 - Synapse.
2. Scilex Holding Company Provides Certain Preliminary Unaudited Financial Results for the Quarter Ended September 30, 2024 - GlobeNewswire.
3. Scilex Holding Company Provides Certain Preliminary Unaudited Financial Results for the Month Ended July 31, 2024 - StockTitan.
4. Scilex Holding Company Announces that its Board of Directors has Authorized Management to Explore Ways to Maximize the Value of its Wholly-Owned Subsidiary Scilex Pharmaceuticals - GlobeNewswire.
5. Scilex Holding Company Generates Record Monthly Revenue In June 2023 and Provides Certain Preliminary Unaudited Financial Results - BioSpace.