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Last Updated: December 22, 2024

HUMATIN Drug Patent Profile


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

Humatin is a drug marketed by King Pfizer, Parkedale, and Parke Davis. and is included in three NDAs.

The generic ingredient in HUMATIN is paromomycin sulfate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the paromomycin sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Humatin

A generic version of HUMATIN was approved as paromomycin sulfate by HERITAGE on December 14th, 2007.

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Summary for HUMATIN
US Patents:0
Applicants:3
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 27
Patent Applications: 5,440
DailyMed Link:HUMATIN at DailyMed
Drug patent expirations by year for HUMATIN

US Patents and Regulatory Information for HUMATIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
King Pfizer HUMATIN paromomycin sulfate CAPSULE;ORAL 062310-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parkedale HUMATIN paromomycin sulfate CAPSULE;ORAL 060521-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parke Davis HUMATIN paromomycin sulfate SYRUP;ORAL 060522-001 Approved Prior to Jan 1, 1982 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

HUMATIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for HUMATIN

Introduction to HUMATIN

HUMATIN is a pharmaceutical product manufactured by Searchlight Pharma Inc., containing the active ingredient paromomycin sulfate, a broad-spectrum antibiotic. Here, we will delve into the market dynamics and financial aspects associated with HUMATIN.

Product Overview

HUMATIN is supplied as a water-soluble capsule, each containing the equivalent of 250 mg of paromomycin. It is marketed for various indications, including the treatment of certain intestinal infections[4].

Regulatory Status

As of October 14, 2022, HUMATIN has been approved and is marketed in Canada, with a Drug Identification Number (DIN) of 02078759. This regulatory approval is crucial for its market presence and sales[4].

Analytical and Quality Control

The analysis of paromomycin in HUMATIN is typically conducted using High-Performance Anion Exchange Chromatography with Integrated Pulsed Amperometric Detection (HPAE-IPAD). This method ensures the accurate quantification of paromomycin within a linear range of 1.25 μM to 10 μM, demonstrating high precision and reliability[1].

Market Competition

The antibiotic market is highly competitive, with several established players. HUMATIN competes with other antibiotics, some of which are blockbuster drugs like Humira (adalimumab) by AbbVie, although these are used for different indications. The pricing and market dynamics of such drugs can influence the overall antibiotic market landscape[3].

Pricing and Revenue

While specific revenue figures for HUMATIN are not publicly available, the pricing of antibiotics can be influenced by various factors, including production costs, regulatory approvals, and market demand. For instance, significant price increases in other blockbuster drugs have led to substantial revenue for their manufacturers. However, HUMATIN's pricing strategy would need to balance profitability with affordability and competition[3].

Financial Health of the Manufacturer

Searchlight Pharma Inc., the manufacturer of HUMATIN, does not have publicly disclosed financial statements. However, the financial health of a pharmaceutical company is often tied to the success of its products, regulatory approvals, and market competition. A strong product portfolio and efficient manufacturing processes are key to maintaining financial stability.

Market Entry and Expansion

For HUMATIN to maintain a strong market presence, Searchlight Pharma Inc. would need to focus on commercial readiness, including marketing strategies, distribution networks, and engagement with healthcare providers and payers. This approach is similar to what companies like Humacyte are doing for their products, such as the Humacyte Vascular Access Graft, which is preparing for a U.S. market launch following FDA Priority Review[2].

Challenges and Opportunities

Challenges

  • Regulatory Compliance: Maintaining compliance with regulatory standards is crucial. Any changes in regulations or issues with compliance can impact the product's market status.
  • Market Competition: The antibiotic market is highly competitive, and HUMATIN must differentiate itself through efficacy, safety, and pricing.
  • Pricing Pressures: The pharmaceutical industry often faces pricing pressures, especially from payers and regulatory bodies.

Opportunities

  • Growing Demand: The demand for effective antibiotics is constant, providing a stable market for HUMATIN.
  • Innovative Marketing: Effective marketing strategies can help HUMATIN gain a larger market share.
  • Expansion into New Markets: Expanding into new geographic markets can increase revenue and growth potential.

Consumer and Healthcare Provider Engagement

Engaging with consumers and healthcare providers is essential for the success of HUMATIN. This includes providing clear product information, reporting side effects, and ensuring optimal, safe, and effective use through detailed product monographs[4].

Financial Trajectory

While specific financial data for HUMATIN is not available, the financial trajectory of a pharmaceutical product is typically influenced by factors such as sales volume, pricing, production costs, and regulatory approvals. A successful product like HUMATIN would aim to achieve steady sales growth, manage costs efficiently, and maintain a strong market presence.

Key Takeaways

  • Regulatory Approval: HUMATIN is approved and marketed in Canada.
  • Analytical Quality: HUMATIN's paromomycin content is accurately quantified using HPAE-IPAD.
  • Market Competition: The antibiotic market is competitive, with HUMATIN competing against other established antibiotics.
  • Financial Health: The financial success of HUMATIN depends on its market performance, regulatory compliance, and competitive pricing.
  • Challenges and Opportunities: HUMATIN faces challenges such as regulatory compliance and market competition but also has opportunities for growth through innovative marketing and expansion into new markets.

FAQs

Q: What is the active ingredient in HUMATIN?

A: The active ingredient in HUMATIN is paromomycin sulfate.

Q: Who manufactures HUMATIN?

A: HUMATIN is manufactured by Searchlight Pharma Inc.

Q: What is the regulatory status of HUMATIN in Canada?

A: HUMATIN is approved and marketed in Canada with a DIN of 02078759.

Q: How is the paromomycin content in HUMATIN analyzed?

A: The paromomycin content in HUMATIN is analyzed using High-Performance Anion Exchange Chromatography with Integrated Pulsed Amperometric Detection (HPAE-IPAD).

Q: What are the key challenges faced by HUMATIN in the market?

A: HUMATIN faces challenges such as regulatory compliance, market competition, and pricing pressures.

Cited Sources

  1. Thermo Fisher Scientific, "Analysis of Paromomycin by HPAE-IPAD"[1].
  2. Investing.com, "Humacyte's Q1 2024 Update: Stepping Closer to Commercial Launch of the Humacyte Vascular Access Graft with FDA's Priority Review"[2].
  3. House of Representatives, "Drug Pricing Investigation"[3].
  4. Drug and Health Products Portal, "Details for: HUMATIN"[4].

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