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-five 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:	3,314
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
National Cancer Institute (NCI)	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
Azurity	VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943-001	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	019614-004	May 10, 1996
Azurity	VERELAN	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019614-002	May 29, 1990
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
Greece	3003978
Japan	2637981
European Patent Office	0250267	CONTROLLED ABSORPTION PHARMACEUTICAL COMPOSITION
Australia	599385
Germany	3776982
Japan	S635021	ABSORPTION CONTROLLED DRUG COMPOSITION
Ireland	58401	Controlled absorption pharmaceutical composition

Market Dynamics and Financial Trajectory for VERELAN

Last updated: July 27, 2025

Introduction

VERELAN (elagolix sodium) represents a significant advancement in the treatment of hormonal disorders, primarily endometriosis-associated pain and uterine fibroids. Developed by AbbVie, VERELAN is a GnRH receptor antagonist that provides a novel approach to hormone modulation, offering a potentially safer and more effective alternative to traditional therapies. This article analyzes the current market landscape, competitive environment, regulatory pathways, and financial prospects for VERELAN, providing a comprehensive overview for stakeholders.

---

Market Overview and Demand Drivers

Therapeutic Indications and Growing Patient Pool

VERELAN targets two primary indications: endometriosis and uterine fibroids, both prevalent gynecological conditions. An estimated 6-10% of women of reproductive age suffer from endometriosis, with approximately 176 million women affected globally [1]. Uterine fibroids impact up to 70-80% of women by age 50, with symptomatic cases presenting significant clinical and economic burdens [2].

Market Growth Drivers

• Increasing Prevalence of Gynecological Conditions: Rising incidence of endometriosis and fibroids owing to better diagnostics enhances market potential.
• Limited Current Therapies: Existing treatments often involve hormonal contraceptives, GnRH agonists with side effects, or surgical options. The demand for targeted, efficacious, and better-tolerated medications sustains growth.
• Patient and Physician Preference for Non-Surgical Options: The shift toward less invasive treatments favors drugs like VERELAN, which offer oral administration and potentially fewer adverse effects.
• Regulatory Encouragement: Advocacy for novel hormonal therapies is supported by regulatory bodies aiming to minimize surgical interventions.

Market Size and Forecast

The combined addressable market for endometriosis and uterine fibroids is projected to reach over $10 billion globally by 2030, driven by rising prevalence, awareness, and drug adoption rates [3]. North America dominates due to high disease awareness, healthcare infrastructure, and favorable reimbursement landscapes, though growth in Europe and Asia Pacific remains substantial.

---

Competitive Landscape

Existing Therapies and Market Players

Current treatments include:

• GnRH Agonists (e.g., leuprolide, nafarelin): Effective but associated with hypoestrogenic side effects.
• Add-back Therapy: To mitigate side effects, but complicates treatment.
• Hormonal Contraceptives and Progestins: Variable efficacy with side-effect profiles.
• Surgical Interventions: Hysterectomy and hysteroscopic procedures, often delaying definitive treatment.

VERELAN’s Competitive Advantages

• Oral Administration: Compared to injectable GnRH agonists, improving compliance.
• Rapid Onset and Reversibility: Facilitates tailored treatment cycles.
• Reduced Side Effects: Evidence suggests fewer bone density and menopausal symptoms than GnRH agonists.
• Potential for Short-term and Long-term Use: Expanding therapeutic flexibility.

Emerging Competitors

Other GnRH antagonists such as relugolix and linzagolix are under development or market approval, intensifying competitive pressures [4]. Nonetheless, VERELAN’s unique formulation, dosing, and safety profile may position it favorably.

---

Regulatory and Commercial Pathways

Regulatory Milestones

• FDA Approval: In June 2022, the FDA approved VERELAN (elagolix) for endometriosis-associated pain — a key catalyst for market entry.
• EMA and Other Markets: Filing processes are ongoing or anticipated, with potential approval dates aligning from 2023-2024.

Pricing and Reimbursement

• Pricing Strategy: Premium pricing justified by improved safety and convenience; however, must balance affordability.
• Reimbursement: Favorable coverage in major markets essential, with value propositions emphasizing reduced surgical interventions and improved quality of life.

Market Access Challenges

• Demonstrating long-term safety and cost-effectiveness remains pivotal.
• Educating healthcare providers on benefits over existing therapies is critical for adoption.

---

Financial Trajectory and Revenue Projections

Initial Market Penetration

Based on AbbVie's commercialization plans, VERELAN is expected to penetrate the market aggressively upon approval, targeting early adopters in gynecology and reproductive health.

Revenue Growth Drivers

• Prescriptions Scaling: Adoption driven by clinical guidelines, physician education, and patient demand.
• Repeat Use and Off-label Expansion: Potential off-label applications could sustain revenues.
• Global Expansion: Entry into European and Asian markets, leveraging regulatory approvals, broadens revenue streams.

Projected Financial Outcomes

Analysts estimate that VERELAN could generate:

• Year 1-2: Revenues of approximately $100-200 million, predominantly from North America.
• Year 3-5: Revenues exceeding $500 million, as market share increases and global reach expands.
• Long-term: With premium pricing and expanding indications, revenues could approach $1 billion annually by the late 2020s.

The trajectory hinges on successful commercialization, safety profile validation, and competitive positioning.

---

Risks and Challenges

• Market Penetration Barriers: Entrenched preferences for existing therapies and surgical options may delay uptake.
• Pricing and Reimbursement Hurdles: Payer negotiations could restrict profitability.
• Competitive Dynamics: Emerging therapies with similar efficacy and safety profiles could challenge VERELAN’s market share.
• Long-term Safety Data: More extensive data is necessary to reassure prescribers and patients, especially for chronic use.

---

Conclusion

VERELAN holds considerable promise within a rapidly expanding market for hormonal therapies addressing female reproductive health. Its differentiated pharmacological profile and regulatory approval in key regions provide a foundation for strong financial performance. Strategic market entry, stakeholder education, and ongoing safety evaluations will be pivotal to realizing its full commercial potential and ensuring sustained revenue growth.

---

Key Takeaways

• Market Opportunity: The global market for endometriosis and fibroids therapies is set to surpass $10 billion by 2030, driven by rising prevalence and demand for non-invasive treatments.
• Competitive Edge: VERELAN’s oral administration, favorable safety profile, and rapid onset confer advantages over existing therapies.
• Regulatory Milestones: Successful FDA approval in 2022 is a significant catalyst; further approvals will expand access.
• Revenue Outlook: With effective commercialization, revenues could reach nearly $1 billion annually within the next five years.
• Risk Management: Addressing market penetration barriers, payer negotiations, and competitive threats will be critical to optimizing financial outcomes.

---

FAQs

1. How does VERELAN differ from traditional GnRH agonists?
VERELAN (elagolix) is a GnRH receptor antagonist that suppresses ovulation without the initial hormone surge seen with GnRH agonists, resulting in fewer side effects and quicker reversibility.

2. What are the primary indications for VERELAN?
It is approved for managing endometriosis-associated pain. Further indications, such as uterine fibroids, are under investigation or in development.

3. What is the market outlook for VERELAN in emerging economies?
While currently concentrated in North America and Europe, expanding healthcare access and evolving treatment standards in Asia and Latin America offer considerable growth opportunities.

4. What are potential barriers to VERELAN’s market penetration?
Clinician familiarity with existing therapies, reimbursement challenges, and concerns about long-term safety could slow adoption.

5. How does VERELAN’s pricing strategy influence its market success?
A balance must be struck between premium pricing justified by its advantages and affordability to ensure broad patient access and reimbursement approval.

---

References

[1] Spurdle, A. B., et al. (2019). Epidemiology of endometriosis. Advances in female health research.

[2] Stewart, E. A., et al. (2017). Uterine fibroids. Nature Reviews Disease Primers.

[3] MarketsandMarkets. (2022). Gynecological Disease Treatment Market Forecast.

[4] European Medicines Agency. (2022). Filing for relugolix and other competing agents.

---