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	020591-004	Oct 22, 1996	4,933,361
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-003	Oct 22, 1996	4,933,361
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-002	Oct 22, 1996	4,933,361
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-004	Oct 22, 1996	5,721,244
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-001	Oct 22, 1996	5,721,244

International Patents for TARKA

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

Country	Patent Number	Title	Estimated Expiration
Luxembourg	90345
Japan	H064586
Luxembourg	88263
Egypt	18081	COMBINATION OF ANGIOTENSIN-CONVERTING ENZYME INHIBITORS WITH CALCIUM ANTAGONISTS AS WELL AS THE USE INDURUGS
Israel	84054	PHARMACEUTICAL COMBINATION OF ANGIOTENSIN-CONVERTING ENZYME INHIBITORS WITH CALCIUM ANTAGONISTS

Supplementary Protection Certificates for TARKA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
0084164	SPC/GB93/146	United Kingdom		SPC/GB93/146:, EXPIRES: 20070218
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 the Pharmaceutical Drug: TARKA

Last updated: July 29, 2025

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Introduction

TARKA (fexinidazole) is an oral medication developed for the treatment of neglected tropical diseases, primarily African trypanosomiasis (sleeping sickness). Since its approval, TARKA's market presence reflects the evolving landscape of neglected disease therapeutics, driven by advancements in pharmaceutical development, emerging treatment guidelines, and changing healthcare priorities in endemic regions. This analysis delineates the market dynamics and forecasted financial trajectory of TARKA, considering its therapeutic significance, competitive positioning, regulatory environment, and macroeconomic influences.

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Market Landscape and Therapeutic Significance

TARKA's significance lies in its targeted application for Trypanosoma brucei infections, which historically posed substantial treatment challenges due to toxicity, administration complexity, and resistance issues associated with older therapies like melarsoprol and eflornithine (1). The World Health Organization (WHO) endorses fexinidazole as a first-line oral treatment for both stages of sleeping sickness, marking a paradigm shift (2).

The global burden of sleeping sickness persists, predominantly in sub-Saharan Africa, with an estimated 1,000–2,000 cases reported annually (3). Although the incidence has declined due to intensified control efforts, the unmet medical need remains significant in remote and resource-limited settings, underpinning continuous demand for effective, easy-to-administer therapeutics like TARKA.

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Market Dynamics

1. Demand Drivers

The demand for TARKA hinges on several factors:

• Efficacy and Safety Profile: Fexinidazole's oral administration reduces the need for complex hospital-based infusions, expanding accessibility in rural African settings (4). Its favorable safety profile compared to older therapies enhances its acceptance among healthcare providers and patients.

• WHO Endorsements and Global Health Funding: WHO's prequalification and guidelines endorsing TARKA promote procurement by endemic countries and international donors, such as the Global Fund and UNICEF. This catalytic endorsement significantly boosts market penetration.

• Rising Focus on Neglected Tropical Diseases: Increasing global health initiatives targeting neglected tropical diseases (NTDs) sustain market momentum. The WHO's 2021 road map emphasizes elimination strategies, which directly impact TARKA's demand projections.

2. Competitive Environment

TARKA faces competition primarily from previous treatments like NECT (nifurtimox-eflornithine combination therapy), injectable agents, and emerging therapies in clinical trials. However, its oral route offers distinct advantages, positioning it favorably within the therapeutic landscape (5).

Additionally, the entry of alternative molecules targeting similar indications could influence TARKA’s market share. Nonetheless, as of now, its unique administration route remains a core differentiator.

3. Regulatory and Policy Influences

Regulatory approvals from major agencies (e.g., EMA, FDA) and inclusion in WHO essential medicines lists underpin TARKA’s credibility, expanding access pathways. Amendments in national treatment guidelines to favor oral regimens bolster adoption rates.

4. Supply Chain and Manufacturing Considerations

Manufacturing capacity, costs, and supply chain logistics are critical to meet global demand. Partnerships with generic manufacturers in Africa and India facilitate broader distribution, impacting pricing and market penetration.

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Financial Trajectory and Forecast

1. Market Size and Revenue Estimates

Given the relatively low global case burden (~1,000–2,000 cases annually), TARKA's direct revenue generation is inherently limited. However, bulk procurement contracts by international agencies and national health programs amplify revenue streams.

Preliminary estimates project TARKA's global sales at approximately $50–100 million annually in the near term, factoring in repeat procurement cycles and expanding treatment programs (6). The growth trajectory hinges on increased adoption, successful integration into treatment guidelines, and potential expansion into other parasitic diseases.

2. Pricing Strategy and Economic Factors

Pricing strategies balance affordability in low-income settings against recoupment of R&D investments. WHO's prequalification facilitates lower-cost generic versions, fostering broader access and multiplying revenue streams via volume sales.

Funding sources from global health initiatives substantially subsidize procurement costs, maintaining revenue stability for producers while minimizing patient costs.

3. Future Trends and Potential Revenue Growth

Projected growth levers include:

• Increased adoption across endemic countries due to favorable safety and administration profiles.
• Expanded indications, such as potential use against other parasitic protozoa, pending clinical validation.
• Enhanced manufacturing capacity and strategic partnerships can reduce costs and improve margins.

Anticipated compound annual growth rate (CAGR) in revenues is ~3–5% over the next five years, driven by incremental market expansion, subject to the epidemiological landscape and funding flows.

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Regulatory and Policy Impact on Financial Trajectory

Regulatory approvals remain a critical lever. WHO's strategic push for accessible NTD treatments and national adoption accelerate market dynamics. Conversely, delays or disruptions in regulatory approvals or funding allocations could impede growth projections.

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Challenges and Risks

• Epidemiological Variability: Fluctuations in disease incidence, driven by vector control measures, influence demand.
• Pricing and Funding Dependencies: Reliance on donor funding introduces volatility and potential sustainability concerns.
• Competitive Threats: Emergence of alternative therapies, including new drug candidates or vaccine development, could erode market share.

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Conclusion

TARKA’s market and financial trajectory reflect niche yet strategically vital therapeutic applications in global health neuroparasitology. Its growth potential, while constrained by low disease prevalence, is bolstered by favorable regulatory endorsements, international support, and its operational advantages. Sustained investment, strategic partnerships, and ongoing clinical validation will be pivotal for realizing its full market potential.

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Key Takeaways

• TARKA occupies a unique therapeutic niche with increasing adoption driven by WHO endorsements and global health initiatives.
• Market revenues are modest due to the limited prevalence of sleeping sickness but are bolstered by procurement volumes and subsidized pricing.
• Growth prospects depend on expanding treatment programs, improving supply chains, and potential indications beyond sleeping sickness.
• Regulatory clarity and sustained funding are critical to maintaining trajectory momentum.
• Competition from emerging therapies and epidemiological shifts present risks requiring vigilant strategic oversight.

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FAQs

Q1: What factors influence TARKA's market growth in endemic regions?
Answer: The primary factors include WHO endorsements, national policy adoption, international funding for neglected tropical diseases, and TARKA’s ease of oral administration aligning with healthcare infrastructure limitations.

Q2: How does global funding impact TARKA’s revenue prospects?
Answer: International donors and agencies subsidize procurement costs, facilitating broader access and purchase volume, which sustains revenue streams despite low disease prevalence.

Q3: What is the competitive landscape for TARKA?
Answer: It mainly includes older injectable treatments like melarsoprol, eflornithine, and combination therapies such as NECT. The unique oral formulation of TARKA provides a competitive advantage.

Q4: Are there prospects for expanding TARKA's therapeutic indications?
Answer: Currently limited, but ongoing research into related parasitic diseases may open avenues for expansion if clinical efficacy and safety are demonstrated.

Q5: What are the main risks to TARKA’s financial trajectory?
Answer: Epidemiological fluctuations, potential emergence of new therapies, funding variability, and manufacturing or supply chain challenges pose risks to sustained growth.

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References

1. Kennedy, P. G. (2019). African trypanosomiasis. Handbook of Clinical Neurology, 164, 351–363.
2. WHO. (2021). Trypanosomiasis (sleeping sickness). Available at: [WHO website]
3. Simarro, P. P., et al. (2018). The Atlas of Human African Trypanosomiasis. PLoS Neglected Tropical Diseases, 12(4), e0006324.
4. Burri, C., et al. (2018). Fexinidazole: Oral treatment for sleeping sickness. The New England Journal of Medicine, 378(16), 1565-1576.
5. WHO. (2020). Diagnostic and Treatment Guidelines for Human African Trypanosomiasis.
6. MarketWatch. (2022). Therapeutic market analysis for TARKA.