CATAPRES-TTS-3 Drug Patent Profile

When do Catapres-tts-3 patents expire, and what generic alternatives are available?

Catapres-tts-3 is a drug marketed by Lavipharm and is included in one NDA.

The generic ingredient in CATAPRES-TTS-3 is clonidine. There are twenty-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the clonidine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Catapres-tts-3

A generic version of CATAPRES-TTS-3 was approved as clonidine by DIFGEN PHARMS on August 18^th, 2009.

Summary for CATAPRES-TTS-3

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	19
Patent Applications:	4,368
DailyMed Link:	CATAPRES-TTS-3 at DailyMed

Recent Clinical Trials for CATAPRES-TTS-3

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rigshospitalet, Denmark	Phase 2/Phase 3
Deventer Ziekenhuis	Phase 3
West Hertfordshire Hospitals NHS Trust	Phase 3

See all CATAPRES-TTS-3 clinical trials

Pharmacology for CATAPRES-TTS-3

Drug Class	Central alpha-2 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha2-Agonists

US Patents and Regulatory Information for CATAPRES-TTS-3

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lavipharm	CATAPRES-TTS-3	clonidine	SYSTEM;TRANSDERMAL	018891-003	Oct 10, 1984	AB	RX	Yes	Yes

Expired US Patents for CATAPRES-TTS-3

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lavipharm	CATAPRES-TTS-3	clonidine	SYSTEM;TRANSDERMAL	018891-003	Oct 10, 1984	4,559,222
Lavipharm	CATAPRES-TTS-3	clonidine	SYSTEM;TRANSDERMAL	018891-003	Oct 10, 1984	3,454,701
Lavipharm	CATAPRES-TTS-3	clonidine	SYSTEM;TRANSDERMAL	018891-003	Oct 10, 1984	4,201,211
Lavipharm	CATAPRES-TTS-3	clonidine	SYSTEM;TRANSDERMAL	018891-003	Oct 10, 1984	4,060,084
Lavipharm	CATAPRES-TTS-3	clonidine	SYSTEM;TRANSDERMAL	018891-003	Oct 10, 1984	3,996,934

International Patents for CATAPRES-TTS-3

See the table below for patents covering CATAPRES-TTS-3 around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	42564
South Korea	840009035
Spain	532228
Norway	772955
Japan	S6214526
Japan	H0460091

CATAPRES-TTS-3 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CATAPRES-TTS-3

Introduction to CATAPRES-TTS-3

CATAPRES-TTS-3, a transdermal therapeutic system containing clonidine hydrochloride, is a centrally acting alpha-agonist hypotensive agent used primarily to treat hypertension. Here, we will delve into the market dynamics and financial trajectory of this medication.

Market Demand and Patient Needs

Hypertension is a widespread and chronic condition that affects millions of people worldwide. The demand for effective antihypertensive medications is high, and CATAPRES-TTS-3 fills a specific niche by offering a convenient, once-weekly transdermal patch that maintains therapeutic plasma concentrations of clonidine for 7 days[1][4].

Competitive Landscape

The antihypertensive market is highly competitive, with numerous oral and transdermal medications available. CATAPRES-TTS-3 competes with other transdermal systems and oral antihypertensive drugs. However, its unique delivery mechanism and the convenience of a weekly application can be significant differentiators in the market[2].

Regulatory Environment

CATAPRES-TTS-3 is approved by regulatory bodies such as the FDA for the treatment of hypertension. Compliance with regulatory requirements and ongoing safety monitoring are crucial for maintaining market presence. Any changes in regulatory policies or new safety data can impact the drug's market dynamics[4].

Clinical Efficacy and Safety

The clinical efficacy of CATAPRES-TTS-3 has been established through various trials, showing it to be effective in reducing blood pressure when used alone or in combination with other antihypertensive agents. However, the drug also has a profile of adverse effects, including dry mouth, drowsiness, and dermatological reactions, which can influence patient and physician preferences[1][4].

Pricing and Reimbursement

The pricing of CATAPRES-TTS-3 is influenced by several factors, including production costs, market competition, and reimbursement policies. In many healthcare systems, the drug may be covered under insurance plans, which can affect its financial trajectory. Pricing strategies must balance profitability with patient access and affordability.

Patient Compliance and Adherence

Patient compliance is a critical factor in the success of any medication. The transdermal delivery system of CATAPRES-TTS-3, which requires application only once a week, can enhance patient adherence compared to daily oral medications. Improved adherence can lead to better health outcomes and increased market share.

Market Penetration and Sales Performance

The sales performance of CATAPRES-TTS-3 is influenced by its market penetration, which depends on factors such as marketing efforts, physician adoption, and patient acceptance. Strong marketing campaigns and educational programs for healthcare providers can increase prescriptions and drive sales.

Financial Trajectory

The financial trajectory of CATAPRES-TTS-3 is tied to its sales performance, pricing, and market share. Here are some key financial aspects:

• Revenue Growth: The revenue generated by CATAPRES-TTS-3 has been steady due to its established presence in the antihypertensive market. Continuous marketing efforts and expanding patient base contribute to revenue growth.
• Cost Structure: The cost of producing CATAPRES-TTS-3 includes the cost of the active ingredient, manufacturing, and distribution. Efficient production processes and supply chain management are essential to maintaining profitability.
• Profit Margins: Profit margins for CATAPRES-TTS-3 are influenced by the pricing strategy, competition, and reimbursement policies. Maintaining a balance between profitability and patient access is crucial.

Challenges and Opportunities

• Challenges:
  • Competition from other antihypertensive medications.
  • Adverse reactions, particularly dermatological reactions, which can lead to treatment discontinuation.
  • Regulatory changes that could impact approval or usage.
• Opportunities:
  • Expanding into new markets, especially in regions with high prevalence of hypertension.
  • Enhancing patient compliance through education and support programs.
  • Potential for use in combination therapies to treat complex hypertension cases.

Future Outlook

The future outlook for CATAPRES-TTS-3 is promising, given the ongoing need for effective antihypertensive treatments. Here are some key points:

• Innovation: Continuous innovation in the delivery system and formulation could enhance patient compliance and reduce side effects.
• Market Expansion: Expanding into new markets and increasing awareness among healthcare providers and patients can drive growth.
• Regulatory Compliance: Staying compliant with regulatory requirements and addressing any safety concerns promptly will be essential for maintaining market presence.

Key Takeaways

• CATAPRES-TTS-3 is a unique transdermal therapeutic system for treating hypertension.
• Market demand is driven by the need for convenient and effective antihypertensive treatments.
• The drug faces competition but has a distinct advantage due to its weekly application.
• Patient compliance and adherence are critical for its success.
• Financial performance is influenced by sales, pricing, and market share.

Frequently Asked Questions (FAQs)

Q: What is CATAPRES-TTS-3 used for? A: CATAPRES-TTS-3 is used to treat high blood pressure (hypertension).

Q: How does CATAPRES-TTS-3 work? A: It works by releasing clonidine at a constant rate through a transdermal patch, which helps to lower blood pressure.

Q: What are the common side effects of CATAPRES-TTS-3? A: Common side effects include dry mouth, drowsiness, fatigue, and dermatological reactions such as contact dermatitis.

Q: How often do you need to apply CATAPRES-TTS-3? A: The patch needs to be applied once a week to maintain therapeutic plasma concentrations of clonidine.

Q: Can CATAPRES-TTS-3 be used with other medications? A: Yes, it can be used alone or in combination with other antihypertensive agents, but this should be done under the guidance of a healthcare provider.

Sources

1. RxList: Catapres-TTS (Clonidine): Side Effects, Uses, Dosage...
2. Mayo Clinic: Clonidine (transdermal route)
3. Florida Department of Health: Okaloosa County CHIP APR
4. FDA: Catapres-TTS Label[1][2][4]