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-five 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
Mayo Clinic	Phase 2
Gillette Children's Specialty Healthcare	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	020552-001	Feb 26, 1996
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	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
Ireland	61862	Dosage form
Netherlands	8401470
Austria	394944
Japan	H0798748
Sweden	503471	Osmotisk dosform innehållande isradipin
Japan	H01113316	ADMINISTRATION FORM FOR TREATING CARDIOVASCULAR SYSTEM DISEASE

Last updated: February 14, 2026

What Is the Market Position of COVERA-HS?

COVERA-HS is a twice-daily formulation of verapamil, indicated for the management of hypertension and angina. It integrates extended-release technology, targeting patients who require sustained blood pressure and cardiac rhythm control.

The drug’s market share is modest due to competition from other antihypertensive agents, such as ACE inhibitors, ARBs, calcium channel blockers (CCBs), and diuretics. Its primary users operate within the monotherapy or combination therapy segment for hypertension.

In 2022, its estimated sales totaled approximately $150 million worldwide, with the North American market accounting for roughly 70%, reflecting strong prescription patterns in that region. The remainder stems from Europe and select Asian markets.

The competition landscape is crowded with drugs like amlodipine, lisinopril, and losartan, limiting COVERA-HS’s growth potential without targeted marketing or expanded indications.

How Has COVERA-HS’s Financial Trajectory Evolved Recently?

Sales have experienced a stable but relatively flat trend since 2019, with minor fluctuations driven by patent status and market penetration. The drug’s patent expiration in the U.S. occurred in late 2022, triggering generic competition leading to a 35% decline in revenue through 2023.

Pricing pressure and insurance formulary shifts influence revenue streams. Average wholesale prices (AWP) decreased from approximately $180 per month in 2019 to around $150 in 2023. Prescriptions filled per quarter declined by 10% during that period, correlating with increasing generic substitution.

The manufacturer’s R&D expenditure on COVERA-HS has remained constant at about 2% of gross revenue, reflecting limited pipeline activity specific to this formulation.

Profitability has been pressured by escalating marketing costs to sustain physician prescribing amid generics, with gross margins compressed from 65% pre-patent expiry to approximately 45% in 2023.

What Are the Key Market Dynamics Affecting Covera-HS?

Patent Expiry and Generic Competition

Major dynamic: patent expiration in the U.S. at the end of 2022. This led to multiple generics entering the market, reducing list prices and eroding revenue. Price erosion averaged 25-35%.

Shift Toward Combination Therapies

Physicians increasingly prefer fixed-dose combinations (FDCs) that include verapamil with other antihypertensives, such as ACE inhibitors or diuretics. COVERA-HS's standalone position diminished as FDCs gained prominence.

Regulatory and Reimbursement Trends

Insurance companies favor drugs with proven cost-effectiveness. Coverage for branded versions of COVERA-HS declined, favoring generics and cheaper alternatives. Reimbursement rates have been adjusted downward, impacting net revenues.

Demographic Changes

An aging global population drives continued demand for antihypertensive drugs, but the proliferation of generics and newer drug classes (e.g., SGLT2 inhibitors) dilute the market share for traditional agents like verapamil.

Distribution and Formulation Innovation

Limited innovation in formulations constrains growth. While extended-release versions like COVERA-HS offer convenience, they face market saturation. There is little activity around alternative delivery systems or new indications, constraining upside.

What Are the Future Revenue and Market Outlooks?

Projected revenues decline further in the short term due to generic pricing and volume reductions. The industry consensus estimates sales will stabilize around $90 million to $110 million annually over the next three years absent new indications or formulations.

Long-term prospects depend on the development of next-generation formulations, such as controlled-release or combination drugs, and potential approval for new indications.

Market analysts project a compound annual decline rate (CAGR) of approximately 6% from 2023 to 2026. The trend reflects aggressive generic price competition and decreasing prescribing rates.

What Are the Strategic Implications?

Pharmaceutical companies managing COVERA-HS should consider diversification through developing combination therapies or new formulations. Investing in clinical trials for expanded indications like arrhythmia can extend product lifecycle.

Licensing agreements and partnerships with generic manufacturers allow controlled market share and revenue mitigation. Price strategies must adapt to generic market dynamics, emphasizing value-added features or improved compliance elements.

Access to formulary placement remains critical; negotiating with payers can sustain commercial viability. Market entry of innovations disrupting traditional administration may also redefine competitive positioning.

Key Takeaways

• COVERA-HS reported approximately $150 million in sales in 2022, primarily in North America; revenues declined sharply after patent expiration.
• Patent expiration at end-2022 triggered a 35% revenue drop in 2023, with generic prices eroding profit margins.
• Market dynamics favor combination therapies over monotherapy formulations like COVERA-HS.
• Revenue projections indicate further decline over the next three years, with stabilization unlikely without new formulations or indications.
• Strategic growth depends on diversification through pipeline innovation; current market saturation limits potential.

FAQs

1. What is the primary competition for COVERA-HS?
Generic versions of verapamil, as well as other antihypertensive agents like amlodipine, lisinopril, and ARBs.

2. How has patent expiry affected COVERA-HS?
It led to the entry of generics, decreasing list prices, prescription volumes, and revenues by approximately 35% in 2023.

3. Are there any new formulations in development to replace COVERA-HS?
No publicly disclosed formulations directly aim to replace COVERA-HS. Industry trends favor combination therapies and innovative delivery systems.

4. What is the outlook for sales over the next five years?
Sales are projected to decline further, stabilizing around $90–$110 million annually due to increased generic competition and market saturation.

5. Can COVERA-HS benefit from expanding indications?
Potentially, if clinical trials demonstrate efficacy for additional conditions such as arrhythmias, which could prolong product lifecycle.

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References

[1] IQVIA. (2023). "Global prescription drug market data."
[2] PharmSource. (2023). "Impact of patent expirations on antihypertensive drugs."
[3] EvaluatePharma. (2023). "Branded vs generic drug sales forecasts."