COVERA-HS Drug Patent Profile

When do Covera-hs patents expire, and when can generic versions of Covera-hs launch?

Covera-hs is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in COVERA-HS is verapamil hydrochloride. There are seventeen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Covera-hs

A generic version of COVERA-HS was approved as verapamil hydrochloride by EXELA PHARMA on March 30^th, 1984.

Summary for COVERA-HS

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	4
DailyMed Link:	COVERA-HS at DailyMed

Recent Clinical Trials for COVERA-HS

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

Sponsor	Phase
Assiut University	Early Phase 1
Gillette Children's Specialty Healthcare	Phase 2
Dartmouth-Hitchcock Medical Center	Phase 2

See all COVERA-HS clinical trials

US Patents and Regulatory Information for COVERA-HS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996		DISCN	No	No
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996		DISCN	No	No

Expired US Patents for COVERA-HS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996

International Patents for COVERA-HS

See the table below for patents covering COVERA-HS around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	884526
Spain	2056660
Australia	566110

COVERA-HS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for COVERA-HS

Introduction to COVERA-HS

COVERA-HS, a formulation of verapamil hydrochloride, is a unique controlled-onset, extended-release (COER) medication designed for the treatment of hypertension and chronic stable angina. Developed by Pfizer, it features a sophisticated delivery system that delays the release of the active drug by 4 to 5 hours, making it ideal for bedtime dosing[1][4].

Pharmacological Profile

Verapamil, the active ingredient in COVERA-HS, is a calcium ion influx inhibitor or calcium channel blocker. It selectively inhibits the transmembrane influx of ionic calcium into arterial smooth muscle and myocardial cells, without altering serum calcium concentrations. This mechanism of action is crucial for its antihypertensive and antianginal effects[1].

Clinical Efficacy

COVERA-HS has been evaluated in several clinical trials, demonstrating its efficacy in reducing blood pressure and improving exercise tolerance in patients with hypertension and chronic stable angina. In studies involving patients with mild to moderate hypertension, COVERA-HS showed significant reductions in ambulatory blood pressures across a 24-hour dosing period. Similarly, in patients with chronic stable angina, it improved exercise tolerance and reduced the frequency of angina attacks[1].

Market Positioning

COVERA-HS was approved by the FDA in 1996, marking it as one of the first chronotherapeutic treatments for hypertension and stable angina. Its unique delivery system, which ensures peak plasma concentrations in the morning hours, aligns with the natural circadian rhythm of blood pressure, making it a preferred choice for managing these conditions[4].

Patient and Provider Acceptance

The drug's efficacy and unique delivery mechanism have contributed to its acceptance among both patients and healthcare providers. The fact that it can be taken once daily at bedtime, with no significant impact from food intake or gastrointestinal conditions, enhances patient compliance[1][4].

Financial Performance and Projections

While specific financial data for COVERA-HS is not readily available, the broader context of prescription drug spending can provide insights. Total prescription drug spending in the U.S. is projected to grow from approximately $500 billion in 2018 to $863 billion by 2028, with retail spending accounting for a significant portion of this growth[3].

Competitive Landscape

In the antihypertensive and antianginal markets, COVERA-HS competes with other calcium channel blockers and various other classes of medications. However, its unique COER delivery system sets it apart, offering a distinct advantage in terms of patient compliance and therapeutic efficacy[1].

Impact of Demographic Factors

Pharmacokinetic studies have shown that older patients have higher mean verapamil concentrations and a longer half-life compared to younger patients. This age-related difference is a common phenomenon in many drug products and highlights the need for careful dosing adjustments in elderly patients[1].

Regulatory and Clinical Trials

COVERA-HS has undergone rigorous clinical trials to establish its safety and efficacy. The drug has been evaluated in placebo-controlled, double-blind studies involving hundreds of patients, demonstrating its clinical and statistical significance in reducing blood pressure and improving exercise tolerance[1].

Pricing and Reimbursement

The pricing of COVERA-HS is influenced by various factors, including production costs, market competition, and reimbursement policies. Given the growing emphasis on value-based care, medications like COVERA-HS that offer significant clinical benefits and improved patient outcomes are likely to be favored in reimbursement decisions[5].

Future Outlook

As the healthcare landscape continues to evolve, medications with advanced delivery systems like COVERA-HS are expected to remain relevant. The increasing focus on patient compliance, therapeutic efficacy, and cost-effectiveness will likely sustain the demand for such medications.

Key Takeaways

• Unique Delivery System: COVERA-HS features a controlled-onset, extended-release system, ideal for bedtime dosing.
• Clinical Efficacy: Demonstrated significant reductions in blood pressure and improvements in exercise tolerance.
• Market Positioning: Approved in 1996 as a chronotherapeutic treatment, it remains a preferred choice for managing hypertension and angina.
• Financial Performance: Part of the growing prescription drug market, projected to reach $863 billion by 2028.
• Competitive Advantage: Unique delivery system enhances patient compliance and therapeutic efficacy.
• Demographic Considerations: Higher drug concentrations and longer half-life in older patients require careful dosing adjustments.

FAQs

Q: What is the unique feature of COVERA-HS? A: COVERA-HS has a controlled-onset, extended-release (COER) delivery system that delays the release of verapamil by 4 to 5 hours, making it suitable for bedtime dosing.

Q: What conditions is COVERA-HS used to treat? A: COVERA-HS is used to treat hypertension and chronic stable angina.

Q: How does the delivery system of COVERA-HS work? A: The delivery system involves a delay coating that solubilizes and releases the drug through precision laser-drilled orifices in the outer membrane at a constant rate, independent of gastrointestinal conditions.

Q: What are the clinical benefits of COVERA-HS? A: COVERA-HS significantly reduces ambulatory blood pressures and improves exercise tolerance in patients with hypertension and chronic stable angina.

Q: How does age affect the pharmacokinetics of COVERA-HS? A: Older patients have higher mean verapamil concentrations and a longer half-life compared to younger patients, requiring careful dosing adjustments.

Cited Sources

1. Pfizer: COVERA-HS - (verapamil hydrochloride) - Pfizer.
2. PR Newswire: Covera Health Announces Up to $50M in Additional Series C Funding to Redefine the Role of Radiology Nationwide.
3. JAMA Health Forum: Projections of US Prescription Drug Spending and Key Policy Considerations.
4. MDPI: Antihypertensives' Rock around the Clock.
5. Business Wire: Covera Health Raises $25M in Series C Financing to Fuel Growth of Its Healthcare Quality Analytics Platform.