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Last Updated: December 23, 2024

CONIVAPTAN HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for conivaptan hydrochloride and what is the scope of patent protection?

Conivaptan hydrochloride is the generic ingredient in two branded drugs marketed by Cumberland and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for CONIVAPTAN HYDROCHLORIDE
US Patents:0
Tradenames:2
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 98
Clinical Trials: 21
Patent Applications: 222
What excipients (inactive ingredients) are in CONIVAPTAN HYDROCHLORIDE?CONIVAPTAN HYDROCHLORIDE excipients list
DailyMed Link:CONIVAPTAN HYDROCHLORIDE at DailyMed
Recent Clinical Trials for CONIVAPTAN HYDROCHLORIDE

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

SponsorPhase
Vanderbilt UniversityPhase 3
Canadian Dermatology FoundationPhase 3
Vanderbilt University Medical CenterPhase 3

See all CONIVAPTAN HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CONIVAPTAN HYDROCHLORIDE

US Patents and Regulatory Information for CONIVAPTAN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cumberland VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER conivaptan hydrochloride INJECTABLE;INTRAVENOUS 021697-002 Oct 8, 2008 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cumberland VAPRISOL conivaptan hydrochloride INJECTABLE;INTRAVENOUS 021697-001 Dec 29, 2005 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CONIVAPTAN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cumberland VAPRISOL conivaptan hydrochloride INJECTABLE;INTRAVENOUS 021697-001 Dec 29, 2005 5,723,606 ⤷  Subscribe
Cumberland VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER conivaptan hydrochloride INJECTABLE;INTRAVENOUS 021697-002 Oct 8, 2008 5,723,606 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

CONIVAPTAN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Conivaptan Hydrochloride (Vaprisol)

Introduction

Conivaptan hydrochloride, marketed under the brand name Vaprisol, is a vasopressin receptor antagonist used to treat euvolemic and hypervolemic hyponatremia in hospitalized patients. Here, we will delve into the market dynamics and financial trajectory of this drug, focusing on its performance within Cumberland Pharmaceuticals Inc.

Market Context

The U.S. vasopressin market, which includes drugs like conivaptan hydrochloride, has been influenced by several factors, including regulatory approvals and the impact of the COVID-19 pandemic.

Regulatory Approvals and Market Growth

The U.S. vasopressin market is expected to grow significantly, driven by increasing regulatory approvals. For instance, the market is projected to exhibit a CAGR of 14.7% from 2021 to 2028, reaching a value of $2,329.9 million by 2028[4].

Impact of COVID-19

During the COVID-19 pandemic, Cumberland Pharmaceuticals initiated efforts to increase the availability of Vaprisol for treating hyponatremia in critical care patients. This initiative was crucial as hyponatremia can often afflict patients in intensive care units[4].

Financial Performance of Vaprisol

Quarterly and Annual Revenues

In the fourth quarter of 2021, Vaprisol generated $0.2 million in net revenue. For the full year 2021, the net revenue from Vaprisol was $1.9 million[1].

In 2023, the revenue from Vaprisol was not explicitly stated in the financial reports, but it is part of the overall product portfolio that contributed to the company's total revenues. The company's combined revenues from all FDA-approved brands were $40 million in 2023[2].

Recent Financial Trends

As of the third quarter of 2024, Cumberland Pharmaceuticals did not provide a specific breakdown for Vaprisol's revenue. However, the company's overall net revenues were $9.1 million for the quarter, with year-to-date revenues of $27 million[3].

Operating Expenses and Net Income

The financial performance of Vaprisol is also influenced by the overall operating expenses and net income of Cumberland Pharmaceuticals.

Operating Expenses

For 2021, the total operating expenses for Cumberland Pharmaceuticals were $43.7 million. In 2023, these expenses increased to $49.1 million, reflecting the company's expanded operations and new product initiatives[1][2].

Net Income

The net loss for Cumberland Pharmaceuticals in 2021 was $(5.6) million, or $(0.37) per share. In 2023, the net loss was approximately $6.3 million, which included a one-time non-cash charge to intangible assets of $3.3 million associated with a product discontinuation[1][2].

Market Dynamics and Competitive Landscape

Competitive Landscape

The U.S. vasopressin market is competitive, with several key players including Par Pharmaceutical, Pfizer Inc., Eagle Pharmaceuticals, Inc., and Astellas Pharma Inc., among others. Cumberland Pharmaceuticals, with its FDA-approved Vaprisol, operates within this competitive landscape[4].

Real-World Studies and Clinical Evidence

Cumberland Pharmaceuticals has focused on generating clinical evidence to support the use of its products. While specific studies on Vaprisol are not highlighted in recent reports, the company's emphasis on real-world studies, such as those conducted for Caldolor, underscores its commitment to demonstrating the efficacy and safety of its products[3].

Patient and Healthcare System Impact

Treatment of Hyponatremia

Vaprisol is critical in treating hyponatremia, a potentially life-threatening condition. Its use can significantly improve patient outcomes by correcting serum sodium levels in hospitalized patients[1][4].

Economic Impact

The treatment of hyponatremia with Vaprisol can also have economic benefits by reducing hospital readmissions and treatment complications, similar to the benefits observed with other Cumberland products like Caldolor[3].

Future Outlook

Regulatory and Market Trends

The future outlook for Vaprisol is influenced by regulatory trends and market demand. The NOPAIN Act, which is set to be implemented in 2025, may provide favorable reimbursement for non-opioid products, although its direct impact on Vaprisol is not specified[2].

Company Initiatives

Cumberland Pharmaceuticals continues to expand its product portfolio and support services. While Vaprisol's specific future is not detailed, the company's overall strategy to deliver unique products that improve patient care suggests ongoing support for its existing brands[3].

Key Takeaways

  • Market Growth: The U.S. vasopressin market, including Vaprisol, is expected to grow significantly due to increasing regulatory approvals and high prevalence of chronic diseases.
  • Financial Performance: Vaprisol's revenue has been modest but consistent, contributing to Cumberland Pharmaceuticals' overall financial performance.
  • Operating Expenses: The company's operating expenses have increased, reflecting expanded operations and new product initiatives.
  • Clinical Evidence: Cumberland Pharmaceuticals emphasizes real-world studies to support the efficacy and safety of its products, including Vaprisol.
  • Patient and Economic Impact: Vaprisol improves patient outcomes and can reduce healthcare costs by minimizing treatment complications.

FAQs

1. What is Vaprisol used for? Vaprisol (conivaptan hydrochloride) is used to treat euvolemic and hypervolemic hyponatremia in hospitalized patients.

2. How has the COVID-19 pandemic affected the availability of Vaprisol? During the COVID-19 pandemic, Cumberland Pharmaceuticals increased the availability of Vaprisol to treat hyponatremia in critical care patients.

3. What are the projected market trends for vasopressin drugs like Vaprisol? The U.S. vasopressin market is expected to grow at a CAGR of 14.7% from 2021 to 2028, driven by increasing regulatory approvals and high prevalence of chronic diseases.

4. What are the key financial metrics for Vaprisol in recent years? In 2021, Vaprisol generated $1.9 million in net revenue. Specific revenue figures for 2023 and 2024 are not provided, but it contributes to the company's overall revenue.

5. How does Vaprisol impact patient care and healthcare costs? Vaprisol improves patient outcomes by correcting serum sodium levels and can reduce healthcare costs by minimizing treatment complications and hospital readmissions.

Sources

  1. Cumberland Pharmaceuticals Reports 2021 Financial Results & Company Update - PR Newswire
  2. Cumberland Pharmaceuticals Reports Annual 2023 Financial Results - PR Newswire
  3. Cumberland Pharmaceuticals Reports Third Quarter 2024 Financial Results and Company Update - PR Newswire
  4. U.S. Vasopressin Market Size, Trends and Forecast to 2028 - Coherent Market Insights

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