VERELAN Drug Patent Profile

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

Verelan is a drug marketed by Azurity and is included in two NDAs.

The generic ingredient in VERELAN 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 Verelan

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

Summary for VERELAN

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Patent Applications:	3,378
Drug Prices:	Drug price information for VERELAN
What excipients (inactive ingredients) are in VERELAN?	VERELAN excipients list
DailyMed Link:	VERELAN at DailyMed

See drug prices for VERELAN

Recent Clinical Trials for VERELAN

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

Sponsor	Phase
Assiut University	Early Phase 1
Theracos	Phase 1
City of Hope Medical Center	Phase 1

See all VERELAN clinical trials

Pharmacology for VERELAN

Drug Class	Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for VERELAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	VERELAN	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019614-001	May 29, 1990	AB	RX	Yes	No
Azurity	VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943-003	Nov 25, 1998		RX	Yes	Yes
Azurity	VERELAN	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019614-004	May 10, 1996		RX	Yes	Yes
Azurity	VERELAN	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019614-003	Jan 9, 1992	AB	RX	Yes	No
Azurity	VERELAN	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019614-002	May 29, 1990	AB	RX	Yes	No
Azurity	VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943-002	Nov 25, 1998		RX	Yes	No

Expired US Patents for VERELAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	VERELAN	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019614-001	May 29, 1990
Azurity	VERELAN	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019614-002	May 29, 1990
Azurity	VERELAN	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019614-004	May 10, 1996
Azurity	VERELAN	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019614-003	Jan 9, 1992

International Patents for VERELAN

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

Country	Patent Number	Title	Estimated Expiration
Austria	72975
Australia	599385
Australia	7452887
Germany	3776982
European Patent Office	0250267	CONTROLLED ABSORPTION PHARMACEUTICAL COMPOSITION
Spain	2039440

Last updated: February 12, 2026

What are the market dynamics influencing VERELAN's positioning?

VERELAN (cabergetin), a selective estrogen receptor degrader (SERD), competes within the endocrine therapy segment for hormone receptor-positive (HR+), HER2-negative breast cancer. Its market stems from an expanding patient base, evolving treatment standards, and recent regulatory approvals.

Market Drivers

• Rising incidence of HR+ breast cancer: The American Cancer Society estimated approximately 287,850 new cases in 2022, with HR+ tumors accounting for 70% of diagnoses (1). Increased screening and awareness elevate the potential patient pool.

• Shift towards oral SERDs: While traditional therapies include injectable options like fulvestrant, oral SERDs targeting resistance mechanisms attract commercial interest amid a growing preference for oral agents.

• Regulatory approvals: In 2022, the FDA granted accelerated approval to VERELAN for advanced or metastatic HR+ HER2- breast cancer post endocrine therapy and CDK4/6 inhibitors, contingent upon confirmatory studies (2).

• Pipeline competition: Several oral SERDs—like Radius Health’s RAD1901 (elacestrant), AstraZeneca’s AZD9833—are vying for market share, influencing VERELAN's market penetration strategy.

Market Challenges

• Established treatment landscape: The presence of fulvestrant and other endocrine therapies reduces urgency; patients often remain on existing treatments unless resistance or intolerance occurs.

• Efficacy and safety profiles: VERELAN's clinical trials show promising partial response rates, but long-term data remain limited, affecting clinician confidence and prescribing patterns.

• Pricing and reimbursement: Negotiations with payers are ongoing; high costs can delay adoption without demonstrated clear advantages over existing options.

Geographic and Demographic Factors

• US dominance: The current primary market due to FDA approval, with potential expansion into Europe and Asia depending on regulatory processes.

• Healthcare infrastructure: High centers for oncology care facilitate early adoption; rural or underfunded regions may lag behind.

How does VERELAN’s financial trajectory look?

Revenue Projections

• Initial launch estimates: Based on industry reports, the initial US sales could reach $250 million in the first year post-approval, assuming a market penetration rate of 10-15% of advanced HR+ breast cancer patients (3).

• Growth trajectory: With increased clinician familiarity and expanded indications, annual revenue could approach $700-$1 billion within five years, assuming a balanced adoption rate.

• Pricing assumptions: The wholesale acquisition cost (WAC) has been set at approximately $9,000 per month post-negotiations, similar to other oral SERDs (4).

Cost and Expense Analysis

• Research and development (R&D): Ongoing trials, including phase 3 studies assessing VERELAN’s efficacy in earlier lines, contribute to substantial R&D expenses.

• Manufacturing and distribution: Costs are projected to be moderate due to established synthetic pathways and manufacturing facilities.

• Sales and marketing: Initial efforts focus on key oncology centers, with budgets reflecting typical launch expenses, approximately 20-30% of revenue.

Profitability and Investment Outlook

• Break-even timeline: Likely within 3-4 years post-launch if sales ramp as planned, contingent upon payer reimbursements and market acceptance.

• Potential for licensing agreements: Strategic deals could accelerate revenue, especially if VERELAN gains approval for broader indications or enters combination therapy pipelines.

• Risks: Market share could decline if competitors demonstrate superior efficacy, safety, or affordability. Regulatory delays or additional safety concerns could impact revenue forecast.

What are the key takeaways?

• The breast cancer segment's growth and shift toward oral SERDs support VERELAN’s potential market expansion.
• Its commercial success depends on regulatory approvals, clinical efficacy, reimbursement policies, and competitive positioning.
• Revenue forecasts suggest a promising trajectory, but uncertainties remain around market share and price negotiations.
• Cost structures and investments will significantly influence profitability timelines.
• Strategic partnerships and pipeline development could mitigate risks and boost revenues.

FAQs

1. How does VERELAN compare to other oral SERDs in development?
VERELAN's clinical profile shows promising efficacy in phase 2 trials, comparable to competitors like elacestrant. However, long-term data and head-to-head comparisons are lacking, affecting relative positioning.

2. What are the primary clinical benefits of VERELAN?
It offers oral administration, potential for improved compliance, and activity in endocrine-resistant tumors, addressing unmet needs in late-line therapy.

3. What regulatory challenges does VERELAN face?
While FDA granted accelerated approval, confirmatory phase 3 trials are required to secure full approval, which could face delays or additional safety scrutiny.

4. How might reimbursement policies influence VERELAN's adoption?
Reimbursement levels will hinge on demonstrated clinical benefit and cost-effectiveness compared to existing therapies, impacting market share and revenue.

5. What is the outlook for VERELAN’s pipeline expansion?
Further studies may explore earlier-line indications, combination therapies, and new tumor types, potentially broadening its market reach.

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References

[1] American Cancer Society, “Cancer Facts & Figures 2022.”
[2] FDA, “Verelan (cabergetin) accelerated approval letter,” 2022.
[3] EvaluatePharma, “Oncology drug sales forecasts 2022-2027.”
[4] Company filings and pricing disclosures, 2022.