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Last Updated: March 26, 2025

VERELAN Drug Patent Profile


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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-three suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.

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Summary for VERELAN
Drug patent expirations by year for VERELAN
Drug Prices for VERELAN

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Recent Clinical Trials for VERELAN

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

SponsorPhase
Assiut UniversityEarly Phase 1
TheracosPhase 1
City of Hope Medical CenterPhase 1

See all VERELAN clinical trials

US Patents and Regulatory Information for VERELAN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Azurity VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-001 May 29, 1990 AB RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Azurity VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-004 May 10, 1996 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Azurity VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020943-003 Nov 25, 1998 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

Expired US Patents for VERELAN

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Azurity VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-001 May 29, 1990 ⤷  Try for Free ⤷  Try for Free
Azurity VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-003 Jan 9, 1992 ⤷  Try for Free ⤷  Try for Free
Azurity VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-004 May 10, 1996 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for Verelan

Overview of Verelan

Verelan, a brand name for the drug verapamil hydrochloride, is a calcium channel blocker used primarily to treat hypertension, angina pectoris, and certain heart rhythm disorders. Here’s a detailed look at the market dynamics and financial trajectory of Verelan.

Market Segmentation

The verapamil hydrochloride market, which includes Verelan, is segmented based on type, application, and geography.

Type

The market is divided into purity levels: Purity Above 98% and Purity Below 98%. In 2023, the Purity Above 98% segment accounted for a significant share of the global market and is projected to experience substantial growth in the near future[1].

Application

Verelan is available in various forms, with the tablet segment being particularly prominent. The tablet segment is expected to expand at a significant CAGR throughout the forecast period[1].

Regional Analysis

The global market for verapamil hydrochloride is segmented into major regions including North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region has its own market size and growth prospects, with Asia-Pacific often showing robust growth due to increasing healthcare demands and economic development[1].

Key Players and Competitive Landscape

Several companies are key players in the verapamil hydrochloride market, including Bharat Pharmaceuticals, Vpl Chemicals Pvt Ltd, Titan Pharma (India) Pvt Ltd, and Wuhan Fortuna Chemical Co. Ltd. These companies are focusing on strengthening their product portfolios and expanding their business globally[1].

Recro Pharma's Role

Recro Pharma, Inc. is a significant player in the market, particularly through its agreements with commercial partners like Lannett Company, Inc. Under the Lannett Agreement, Recro Pharma receives a share of profits on sales of Verelan PM and SR, as well as an annual license fee and reimbursement for certain program fees[3].

Financial Trajectory

Revenue and Profit Sharing

Recro Pharma generates revenue from the sales of Verelan through profit-sharing agreements with Lannett. For instance, Lannett pays Recro Pharma a share of profits on sales of Verelan PM and SR, along with an annual license fee of $500,000 and reimbursement for 50% of the Prescription Drug User Act program fees associated with Verelan[3].

Market Growth

The global controlled release drug delivery market, which includes Verelan, is expected to grow significantly. By 2028, this market is projected to reach over $90 billion, driven by the increasing demand for controlled-release drugs in treating various conditions such as hypertension, angina pectoris, and other chronic diseases[4].

Pricing and Cost

The cost of Verelan PM, an extended-release oral capsule, can vary depending on the pharmacy but is generally around $712 for a supply of 100 capsules[5].

Market Drivers and Opportunities

Controlled Release Technology

The advancement in controlled release technology is a major driver for the market. This technology ensures the maintenance of the desired drug concentration in the patient, reducing side effects and toxicity. It also offers non-toxicity and biocompatibility, making it highly acceptable among researchers and patients[4].

Increasing Healthcare Needs

The growing need for effective treatments for chronic conditions such as hypertension and angina pectoris is driving the demand for drugs like Verelan. The aging population and increasing prevalence of these conditions are expected to further boost the market[4].

Challenges and Restraints

Regulatory Compliance

Companies involved in the manufacture and distribution of Verelan must comply with stringent regulatory requirements. This includes maintaining excellent quality and regulatory compliance systems, which can be a challenge and a significant cost factor[3].

Patent and Licensing Issues

The expiration and renewal of licensing agreements, such as the Lannett Agreement, can impact the financial trajectory of companies like Recro Pharma. Ensuring continuous revenue streams through these agreements is crucial[3].

Consumer Behavior and Side Effects

Reporting Side Effects

Consumers are encouraged to report any side effects associated with Verelan, which helps in monitoring the safety and efficacy of the drug. This feedback is crucial for regulatory bodies and manufacturers to ensure the optimal use of the product[2].

Technological Trends

Modified Release Mechanisms

The development of extended, controlled, and sustained release mechanisms is a key technological trend in the market. Companies like Recro Pharma specialize in these technologies, which enhance the delivery and efficacy of drugs like Verelan[3].

SWOT Analysis

Strengths

  • Strong relationships with commercial partners
  • Operational excellence and quality compliance
  • Specialized expertise in controlled release formulations

Weaknesses

  • Dependence on a small number of commercial partners
  • High regulatory compliance costs
  • Potential patent and licensing issues

Opportunities

  • Growing demand for controlled release drugs
  • Expanding into new market segments
  • Increasing healthcare needs in emerging markets

Threats

  • Competitive market with multiple players
  • Regulatory changes and compliance challenges
  • Economic fluctuations affecting healthcare spending

Key Takeaways

  • Verelan is a significant player in the verapamil hydrochloride market, driven by its controlled release technology.
  • The market is segmented by type, application, and geography, with the Purity Above 98% segment and tablet form being prominent.
  • Recro Pharma’s agreements with commercial partners like Lannett are crucial for its revenue.
  • The global controlled release drug delivery market is expected to grow substantially by 2028.
  • Regulatory compliance and patent issues are key challenges.

FAQs

What is Verelan used for?

Verelan is used to treat hypertension, angina pectoris, and certain heart rhythm disorders.

Who are the key players in the verapamil hydrochloride market?

Key players include Bharat Pharmaceuticals, Vpl Chemicals Pvt Ltd, Titan Pharma (India) Pvt Ltd, and Wuhan Fortuna Chemical Co. Ltd.

What is the expected growth of the controlled release drug delivery market?

The market is expected to reach over $90 billion by 2028.

How does Recro Pharma generate revenue from Verelan?

Recro Pharma generates revenue through profit-sharing agreements with Lannett and annual license fees.

What are the main challenges faced by manufacturers of Verelan?

Manufacturers face challenges such as regulatory compliance, patent and licensing issues, and dependence on a small number of commercial partners.

Sources

  1. Cognitivemarketresearch.com: Verapamil Hydrochloride Market Report 2024 (Global Edition)
  2. Dhpp.hpfb-dgpsa.ca: Details for: VERELAN - Drug and Health Products Portal
  3. Annualreports.com: Recro Pharma, Inc. - Annual Reports
  4. Prnewswire.com: Global Controlled Release Drug Delivery Market Report 2022
  5. Drugs.com: Verelan PM Prices, Coupons, Copay Cards & Patient Assistance

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