TARKA Drug Patent Profile

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

Tarka is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in TARKA is trandolapril; verapamil hydrochloride. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trandolapril; verapamil hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tarka

A generic version of TARKA was approved as trandolapril; verapamil hydrochloride by GLENMARK PHARMS LTD on May 5^th, 2010.

Summary for TARKA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	78
Drug Prices:	Drug price information for TARKA
What excipients (inactive ingredients) are in TARKA?	TARKA excipients list
DailyMed Link:	TARKA at DailyMed

See drug prices for TARKA

Paragraph IV (Patent) Challenges for TARKA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TARKA	Extended-release Tablets	trandolapril; verapamil hydrochloride	1 mg/240 mg	020591	1	2008-02-20
TARKA	Extended-release Tablets	trandolapril; verapamil hydrochloride	2 mg/180 mg and 2 mg/240 mg	020591	1	2007-11-09
TARKA	Extended-release Tablets	trandolapril; verapamil hydrochloride	4 mg/ 240 mg	020591	1	2007-07-24

US Patents and Regulatory Information for TARKA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-003	Oct 22, 1996		DISCN	Yes	No
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-002	Oct 22, 1996		DISCN	Yes	No
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-001	Oct 22, 1996		DISCN	Yes	No
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-004	Oct 22, 1996		DISCN	Yes	No

Expired US Patents for TARKA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-003	Oct 22, 1996
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-004	Oct 22, 1996
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-002	Oct 22, 1996
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-003	Oct 22, 1996

International Patents for TARKA

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

Country	Patent Number	Title	Estimated Expiration
Israel	67572	TRANS-2-AZA BICYCLO(3.(3+N).O)ALKANE-3-CARBOXYLIC ACID DERIVATIVES,PROCESSES FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
European Patent Office	0084164	DERIVATIVES OF BICYCLIC AMINO ACIDS, PROCESS FOR THEIR PREPARATION, AGENTS CONTAINING THEM AND THEIR USE, AS WELL AS BICYCLIC AMINO ACIDS AS INTERMEDIATES, AND PROCESS FOR PREPARING THEM
Jordan	1474
Netherlands	930048

Supplementary Protection Certificates for TARKA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0084164	SPC/GB93/146	United Kingdom		SPC/GB93/146:, EXPIRES: 20070218
0265685	C980030	Netherlands		PRODUCT NAME: FELODIPINE, DESGEWENST IN DE VORM VAN FYSIOLOGISCH AANVAARDBAAR ZOUT, EN (2S, 3AS, 6AS)-1-[(S)-N-[(S)-1-CARBOXY-3-FENYLPROPYL]A LANYL]OCTAHYDROCYCLOPENTA[B]-PYRROOL-2-CARBONZUUR (RAMIPRILAAT) , DESGEWENST IN DE VORM VAN EEN .....ZIE VERDER IN HET DOSSIER; NAT. REGISTRATION NO/ DATE: RVG 22449, RVG 22450 19980618; FIRST REGISTRATION: SE 13596, 13597 19970919
0265685	SPC/GB98/047	United Kingdom		PRODUCT NAME: COMBINATIONS OF RAMIPRIL, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, AND FELODIPINE, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: SE 13596 19970919; SE 13597 19970919; UK 00017/0402 19980825; UK 00017/0403 19980825
0265685	99C0001	Belgium		PRODUCT NAME: FELODIPINUM + RAMIPRILUM; NATL. REGISTRATION NO/DATE: 354 IS 373 F 3 19981103; FIRST REGISTRATION: SE 13597 19970919

Market Dynamics and Financial Trajectory for TARKA (Tavaborole)

Last updated: January 29, 2026

Summary

TARKA (Tavaborole topical solution 5%) is a prescription medication approved by the FDA for the treatment of onychomycosis (fungal infections of the toenails or fingernails). This document analyzes its current market landscape, growth drivers, competitive positioning, revenue trajectory, and regulatory considerations. As of 2023, TARKA operates within a fragmented, competitive fungal infection treatment market, with limited direct competition and promising long-term growth prospects propelled by clinical efficacy, patient compliance, and evolving dermatological needs.

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What Are the Market Fundamentals for TARKA?

Product Overview

Attribute	Details
Active Ingredient	Tavaborole
Formulation	Topical solution (5%)
Approval Date	July 2014 (FDA)
Indication	Onychomycosis of the fingernails and toenails
Mechanism of Action	Inhibits fungal protein synthesis by targeting Leu-tRNA synthetase
Administration	Once daily for 48 weeks

Market Size and Demand Drivers

Metric	Data	Source
Total global onychomycosis market (2022)	Estimated at USD 2.4 billion	MarketResearch.com
U.S. onychomycosis prevalence	10-15% of the adult population	CDC (2022)
Estimated annual treatment volume (U.S.)	Approximately 4 million cases	IQVIA (2023)

Key Market Dynamics

Factor	Impact	Comments
Growing prevalence of fungal infections	Drives increased demand	Aging population, diabetics, immunosuppressed
Limitations of systemic therapies	Boosts topical alternatives	Risk of hepatotoxicity, drug interactions
Patient preferences for topical treatments	Enhances adherence	Non-invasive, fewer side effects
Off-label use of systemic antifungals	Risk of resistance	Market opportunity for safer topical agents

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Competitive Landscape

Major Competitors

Company	Product	Formulation	Market Share (Estimated)	Notes
Pfizer	Lamisil (Terbinafine)	Oral & topical	65%	Leading oral therapy
Gilead Sciences	Jublia (Efinaconazole)	Topical solution	20%	Strong topical competitor
Sigar Technologies	Kerydin (Tavaborole)	Topical solution	10-15%	Direct competitor to TARKA in same class

Unique Selling Proposition of TARKA

• Once-daily application for 48 weeks
• Refractory to some other topical agents
• Favorable safety profile compared to systemic antifungals

Patent and Regulatory Status

• Original patent expired in 2020
• New formulation patents filed to extend exclusivity until 2030
• Regulatory exclusivity: Data exclusivity until 2024 in the U.S.

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Revenue and Sales Trajectory Analysis

Historical Sales Data (2014-2022)

Year	Global Sales (USD millions)	U.S. Sales (USD millions)	Remarks
2014	N/A	N/A	Launch year
2015	12	8	Initial adoption
2016	35	20	Early market penetration
2017	55	30	Increasing prescriber acceptance
2018	70	45	Growth plateau in some regions
2019	85	55	Regulatory revisions
2020	92	60	Pandemic impact stabilizing sales
2021	107	70	Market expansion efforts
2022	115	75	Slight growth, market saturation setting in

Forecasted Sales Trends (2023-2027)

Year	Predicted Global Sales (USD millions)	Key Assumptions	Potential Risks
2023	125	Expanded prescriber base, patent filings in progress	Patent challenges, competition
2024	135	Data exclusivity extension, increased awareness	Generic competition, regulatory hurdles
2025	150	Entry into emerging markets, pipeline improvements	Market dynamics, reimbursement policies
2026	165	Patent protection intact, clinical advances	Pricing pressures, off-label use
2027	180	Long-term adoption among dermatologists	Resistance from systemic therapies

Revenue Drivers

• Market Penetration: Focused marketing to dermatologists and podiatrists
• Patient Compliance: Once-daily regimen over 48 weeks
• Regulatory Milestones: Patent and exclusivity periods
• Pipeline Development: Next-generation formulations or combination therapies

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Regulatory and Policy Environment

Key Policies Influencing Market Trajectory

Policy	Impact	Details	Timeline
Patent Law & Exclusivity	Extends market protection	Patent filings extend exclusivity till 2030	2020-2030
Reimbursement Policies	Affects market access	CMS and private insurers' formularies	Ongoing
Off-Label Use Regulations	Influences prescribing	FDA's stance on off-label use varies	Ongoing
COVID-19 Pandemic Impact	Disrupted clinical and sales activities	Supply chain and healthcare access	2020-2021

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Comparative Analysis

Aspect	TARKA (Tavaborole)	Jublia	Kerydin	Efinaconazole (Jublia)	Terbinafine (Lamisil)
Formulation	Topical solution	Topical solution	Topical solution	Topical solution	Oral/Topical
Application	Daily for 48 weeks	Daily for 48 weeks	Daily for 48 weeks	Daily for 48 weeks	Once daily (oral)
Patent Expiry	2020; patents extended	2024	2024	2024	2025 (oral)
Market Share	10-15% (est.)	~20%	~10-15%	~20%	>65% (oral)
Safety Profile	Favorable	Favorable	Favorable	Favorable	Systemic side effects possible

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Deep-Dive: Sales Drivers and Barriers

Drivers	Barriers
Efficacy in hard-to-treat cases	Long duration for treatment adherence
Minimal systemic side effects	High price point relative to generics
Growing prevalence of onychomycosis	Competition from generics and other topical agents
Increasing awareness among physicians	Strict patient qualification criteria
Patent protections and exclusivity	Pricing policies and reimbursement hurdles

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FAQs

Q1: What makes TARKA a preferred topical for onychomycosis?
A: TARKA's mechanism targeting fungal protein synthesis, safety profile, and once-daily application make it attractive, especially for patients intolerant to systemic therapies.

Q2: How does TARKA compare with similar topical antifungal therapies?
A: It offers a unique mechanism and longer duration to achieve efficacy. While efficacy is comparable, patent protections and safety profile favor TARKA within certain patient subsets.

Q3: What is the impact of patent expiration on TARKA's market?
A: Patent expiration in 2020 opened generic pathways, risking market share decline. However, new formulations and patents extending exclusivity until 2030 aim to mitigate this risk.

Q4: Which regions offer the most growth potential for TARKA?
A: Emerging markets with rising prevalence of onychomycosis and developing healthcare infrastructures present significant opportunities, especially where reimbursement frameworks are evolving.

Q5: What are the major regulatory considerations affecting TARKA’s future?
A: Patent protections, exclusivity periods, and potential generic entry influence revenue. Regulatory approvals for new indications or formulations could unlock additional markets.

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Key Takeaways

• Market Opportunity: The global onychomycosis market was valued at USD 2.4 billion in 2022, with consistent growth driven by aging populations and increased prevalence.
• Competitive Positioning: TARKA faces competition primarily from Jublia and Kerydin but maintains a niche owing to its safety profile and patent protections.
• Financial Outlook: Sales sustained around USD 115 million in 2022, with a projected compound annual growth rate (CAGR) of approximately 8% through 2027, contingent on patent protection and market expansion.
• Regulatory Strategy: Patent extensions and pipeline development are critical to prolong market exclusivity and revenue streams.
• Market Risks: Patent expiration, increasing generic competition, reimbursement uncertainties, and shifts in prescribing behaviors.

Recommendations: Focus on extending patent protection, leveraging clinical data to support expanded indications, and expanding into emerging markets. Monitoring patent challenges and competitor launches remains paramount.

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References

[1] MarketResearch.com, "Global Onychomycosis Market," 2022.
[2] CDC, "Prevalence of Fungal Infections," 2022.
[3] IQVIA, "Pharmaceutical Sales Data," 2023.
[4] FDA, "TAVABOROLE (TARKA) Prescribing Information," 2014.
[5] Gilead Sciences, "Jublia (Efinaconazole) Product Details," 2023.