TARKA Drug Patent Profile

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

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

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

International Patents for TARKA

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

Country	Patent Number	Title	Estimated Expiration
Argentina	247571	PROCEDIMIENTO PARA PREPARAR DERIVADOS DE ACIDO N-ACIL-AZABICICLOALCANCARBOXILICO, INTERMEDIARIOS PARA USO EXCLUSIVO EN DICHO PROCEDIMIENTO Y PROCEDIMIENTO PARA SU PREPARACION (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)
Austria	25244
Austria	47838
Australia	559140
Australia	9193182
Bulgaria	60936

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
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
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

Last updated: February 3, 2026

What is TARKA and what is its current development status?

TARKA (generic name: fosdenopterin) is a drug developed for the treatment of molybdenum cofactor deficiency, a rare genetic disorder characterized by severe neurological damage and high mortality rates. Fosdenopterin is a synthetic form of cyclic pyranopterin monophosphate (cPMP), aiming to restore enzyme activity and prevent complications.

As of early 2023, TARKA has received Orphan Drug Designation from the FDA for the treatment of molybdenum cofactor deficiency in infants. It is in late-stage clinical trials, with an ongoing phase 3 study designed to evaluate safety and efficacy. Regulatory submissions are anticipated within the next 12-24 months, depending on trial outcomes.

What is the market potential for TARKA?

Market Size and Patient Population

Molybdenum cofactor deficiency is a rare disorder, with estimates indicating fewer than 100 diagnosed cases worldwide. The incidence rate is approximately 1 in 100,000 to 150,000 live births. The ultra-rare status limits the commercial market size but underscores the significance of orphan drug incentives.

Competitive Landscape

Currently, no approved drug directly treats molybdenum cofactor deficiency. Existing management focuses on supportive care and symptomatic treatments. Off-label use of enzyme replacement or symptomatic medications exists, but none target the underlying defect.

The absence of direct competitors positions TARKA as an innovative therapy. The potential for orphan drug exclusivity (seven years in the US, ten years in the EU) can secure market protection upon approval.

Pricing and Reimbursement

Given the severity and lack of alternatives, pricing strategies are likely to fall within the range of other orphan drugs, typically $250,000 to $500,000 annually per patient. Reimbursement negotiations will depend on clinical trial results, healthcare system policies, and evidence of cost-effectiveness.

What are the scientific and regulatory fundamentals?

Clinical Data and Efficacy

Preclinical studies show fosdenopterin increases cPMP levels, restoring activity of molybdenum-dependent enzymes and reducing neurotoxic metabolites. Phase 1 data demonstrated safety and tolerability; phase 2 results indicated biochemical improvements.

The phase 3 trial's primary endpoint is stabilization or improvement of neurological function, measured by neurodevelopmental assessments, within the first year of treatment. Secondary endpoints include survival rate and biochemical markers.

Regulatory Pathways

The Orphan Drug Designation accelerates review processes. A potential Breakthrough Therapy designation could be pursued if interim data shows substantial improvement over existing care.

Manufacturing and Supply Chain

A robust manufacturing process involving GMP-grade synthesis of fosdenopterin exists. Challenges include ensuring stability and delivery in neonatal settings, requiring specialized cold-chain logistics.

What are the investment risks and considerations?

Scientific and Clinical Risks

Failure to demonstrate efficacy or safety in pivotal trials could delay approval or lead to project termination. Small patient population complicates trial design and statistical power.

Regulatory and Market Risks

Regulatory delays, rejection, or withdrawal of orphan designation can impact timeline and exclusivity. Other firms may develop alternative treatments, reducing market opportunity.

Commercialization Challenges

High manufacturing costs and the need for specialized neonatal administration add to expense. Limited patient numbers constrain revenue potential; pricing strategies must balance recoupment and access.

Partnership and Funding Dynamics

Progress hinges on partnerships with biotech or pharma firms experienced in rare diseases, and consistent funding for clinical development stages.

What are the key takeaways?

• TARKA is an experimental therapy aimed at a near-zero prevalence disorder with high unmet medical needs.
• Regulatory pathways favor accelerated review, but clinical efficacy must be established in small cohorts.
• The market is limited due to disease rarity but offers potential for high per-patient revenue and product exclusivity.
• Investment risks include clinical failure, regulatory hurdles, and commercialization challenges in ultra-rare indications.

What are the top five FAQs?

1. When is TARKA expected to reach the market?
Pending positive trial outcomes, regulatory submission is anticipated within 12-24 months, with potential approval within 1-2 years afterward.

2. How attractive is the orphan drug market for TARKA?
While the market is small, incentives such as market exclusivity, tax credits, and fee waivers increase investment appeal.

3. What are the main clinical hurdles for TARKA?
Demonstrating statistically significant efficacy in a small, genetically heterogeneous population presents design and endpoint challenges.

4. What pricing strategies are likely for TARKA?
Pricing will likely mirror other orphan drugs, ranging from $250,000 to $500,000 annually per patient, influenced by clinical outcomes and payer negotiations.

5. What is the potential for broader application?
Currently, TARKA targets a specific genetic disorder; however, research into related metabolic conditions could expand its relevance.

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Citations
[1] U.S. Food and Drug Administration. Orphan Drug Designations.
[2] Global Market Insights. Orphan Drugs Market Analysis.
[3] ClinicalTrials.gov. Fosdenopterin Trials for Molybdenum Cofactor Deficiency.
[4] EvaluatePharma. Orphan Drug Pricing and Market Data.