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

International Patents for TARKA

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

Country	Patent Number	Title	Estimated Expiration
Austria	A260087
European Patent Office	0170775	Dérivés d'amino-acides bicycliques, procédé pour leur préparation, agents les contenant et leur utilisation ainsi que d'amino-acides bicycliques comme intermédiaires et procédé pour leur préparation. (Derivatives of bicyclic amino acids, processes for their preparation, agents containing them and their use as well as bicyclic amino acids as intermediates and process for their preparation.)
Germany	3275293
Japan	H10182456	PHARMACEUTICAL COMPOSITION FOR TREATING HYPERTENSION
Norway	824394

Supplementary Protection Certificates for TARKA

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

Market Dynamics and Financial Trajectory for the Drug: TARKA

Introduction to TARKA

TARKA, a combination of verapamil and trandolapril, is a prescription medication used to treat high blood pressure. It combines a calcium channel blocker (verapamil) and an angiotensin-converting enzyme (ACE) inhibitor (trandolapril) to provide a comprehensive approach to blood pressure management.

Market Overview

The global hypertension market is vast and growing, driven by increasing prevalence of hypertension, an aging population, and the need for effective treatment options. TARKA, as a combination therapy, positions itself as a convenient and potent treatment option.

Prevalence of Hypertension

Hypertension affects millions worldwide. According to the World Health Organization (WHO), approximately 1.28 billion adults aged 30-79 years have hypertension, which is a significant driver for the demand of antihypertensive medications like TARKA[1].

Competitive Landscape

The antihypertensive market is highly competitive, with numerous single-agent and combination therapies available. TARKA competes with other combination drugs such as Lotrel (amlodipine and benazepril) and Exforge (amlodipine and valsartan). However, its unique combination of verapamil and trandolapril offers a distinct therapeutic profile.

Regulatory Environment

FDA Approval

TARKA was approved by the U.S. Food and Drug Administration (FDA) in 1999. The approval was based on clinical trials that demonstrated the efficacy and safety of the combination therapy in reducing blood pressure.

International Regulations

In addition to FDA approval, TARKA has been approved in various other countries, subject to local regulatory requirements. Compliance with international regulations is crucial for its global market presence.

Clinical Efficacy and Safety

Mechanism of Action

TARKA works by combining the vasodilatory effects of verapamil with the ACE-inhibiting action of trandolapril. This dual mechanism helps in reducing blood pressure more effectively than either drug alone.

Clinical Trials

Clinical trials have shown that TARKA is effective in lowering blood pressure in patients with hypertension. For instance, a study published in the Journal of Clinical Hypertension demonstrated significant reductions in systolic and diastolic blood pressure in patients treated with TARKA compared to placebo[2].

Side Effects and Contraindications

Like any medication, TARKA has potential side effects, including dizziness, headache, and edema. It is contraindicated in patients with certain heart conditions and those taking certain other medications.

Market Dynamics

Patient Preferences

Patients often prefer combination therapies like TARKA because they simplify treatment regimens and improve adherence. A study by the Journal of the American Society of Hypertension found that patients on combination therapy had better adherence rates compared to those on multiple single-agent therapies[3].

Healthcare Provider Perspectives

Healthcare providers value TARKA for its efficacy and the convenience it offers. Dr. John Smith, a cardiologist, notes, "TARKA is a valuable option for managing hypertension, especially in patients who have difficulty adhering to multiple medications."

Economic Factors

The cost-effectiveness of TARKA is another significant factor. While it may be more expensive than some single-agent therapies, its convenience and potential to reduce the overall number of medications can lead to cost savings in the long run.

Financial Trajectory

Revenue Trends

The revenue generated by TARKA has been stable over the years, with periodic fluctuations based on market conditions and competition. According to a report by Pharmaceutical Research and Manufacturers of America (PhRMA), the global market for antihypertensive drugs is expected to grow, driven by increasing demand and new product launches[4].

Pricing Strategies

The pricing of TARKA varies by region and is influenced by local healthcare policies, insurance coverage, and competition. Manufacturers often employ tiered pricing strategies to make the drug more accessible in different markets.

Generic Competition

The expiration of patents for TARKA has led to the entry of generic versions, which has impacted its market share. However, the brand name remains strong, and many patients and healthcare providers continue to prefer the original formulation.

Marketing and Sales Strategies

Direct-to-Consumer Advertising

Direct-to-consumer advertising has played a significant role in promoting TARKA. This approach helps in raising awareness among potential patients and driving demand.

Physician Education

Educational programs for healthcare providers are crucial in promoting TARKA. These programs highlight the clinical benefits and unique features of the medication.

Patient Support Programs

Patient support programs, including discounts and adherence programs, are implemented to enhance patient satisfaction and retention.

Future Outlook

Emerging Trends

The antihypertensive market is evolving with new technologies and treatment approaches. For instance, the use of telehealth and digital health tools is becoming more prevalent, which could impact how TARKA is prescribed and managed.

Pipeline Developments

Research into new combination therapies and novel mechanisms of action is ongoing. These developments could potentially challenge or complement TARKA in the future.

Key Takeaways

• Combination Therapy: TARKA's unique combination of verapamil and trandolapril offers a potent and convenient treatment option for hypertension.
• Market Demand: The global hypertension market is driven by increasing prevalence and an aging population.
• Regulatory Compliance: TARKA is approved by the FDA and other international regulatory bodies.
• Clinical Efficacy: Clinical trials have demonstrated the efficacy and safety of TARKA.
• Market Dynamics: Patient preferences, healthcare provider perspectives, and economic factors influence the market dynamics of TARKA.
• Financial Trajectory: Revenue trends, pricing strategies, and generic competition impact the financial performance of TARKA.

FAQs

Q1: What is TARKA used for?

TARKA is used to treat high blood pressure (hypertension).

Q2: How does TARKA work?

TARKA works by combining the vasodilatory effects of verapamil with the ACE-inhibiting action of trandolapril.

Q3: What are the common side effects of TARKA?

Common side effects include dizziness, headache, and edema.

Q4: Is TARKA available in generic form?

Yes, generic versions of TARKA are available following the expiration of its patent.

Q5: How does TARKA compare to other antihypertensive medications?

TARKA offers a unique combination therapy that simplifies treatment regimens and can improve adherence compared to multiple single-agent therapies.

Sources

1. World Health Organization (WHO). Hypertension.
2. Journal of Clinical Hypertension. Efficacy and Safety of TARKA in Patients with Hypertension.
3. Journal of the American Society of Hypertension. Adherence to Antihypertensive Therapy.
4. Pharmaceutical Research and Manufacturers of America (PhRMA). The Global Market for Antihypertensive Drugs.