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Last Updated: April 21, 2025

Igi Labs Inc Company Profile


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What is the competitive landscape for IGI LABS INC

IGI LABS INC has fifty-three approved drugs.

There is one tentative approval on IGI LABS INC drugs.

Summary for Igi Labs Inc
US Patents:0
Tradenames:13
Ingredients:13
NDAs:53

Drugs and US Patents for Igi Labs Inc

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Igi Labs Inc FUROSEMIDE furosemide INJECTABLE;INJECTION 070095-001 Sep 9, 1985 DISCN No No ⤷  Try for Free ⤷  Try for Free
Igi Labs Inc MEPERIDINE HYDROCHLORIDE meperidine hydrochloride INJECTABLE;INJECTION 089787-001 Mar 31, 1989 DISCN No No ⤷  Try for Free ⤷  Try for Free
Igi Labs Inc NALBUPHINE HYDROCHLORIDE nalbuphine hydrochloride INJECTABLE;INJECTION 072075-001 Apr 10, 1989 DISCN No No ⤷  Try for Free ⤷  Try for Free
Igi Labs Inc NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 072087-001 Apr 11, 1989 DISCN No No ⤷  Try for Free ⤷  Try for Free
Igi Labs Inc TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 063122-001 Oct 31, 1994 DISCN No No ⤷  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 5 of 5 entries
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Pharmaceutical Competitive Landscape Analysis: IGI Labs Inc – Market Position, Strengths & Strategic Insights

In the dynamic and highly competitive pharmaceutical industry, understanding the market landscape is crucial for success. This article delves into the competitive position of IGI Labs Inc, exploring its strengths, market position, and strategic insights. By analyzing IGI Labs' performance and comparing it to industry trends, we can gain valuable insights into the company's potential and challenges in the pharmaceutical sector.

IGI Labs Inc: Company Overview

IGI Labs Inc, now known as Teligent Inc, is a specialty generic pharmaceutical company based in New Jersey[7]. The company focuses on developing, manufacturing, and marketing topical formulations for pharmaceutical, over-the-counter (OTC), and cosmetic markets[3].

"Our mission is to be a leading player in the generic topical prescription drug market." - Jason Grenfell-Gardner, President and CEO of IGI Laboratories (now Teligent Inc)[3]

Market Position and Product Portfolio

IGI Labs has positioned itself as a niche player in the generic topical pharmaceutical market. The company's strategy revolves around developing and manufacturing topical generic pharmaceutical products, which has allowed it to carve out a specific market segment[3].

Key Product Areas:

  • Topical generic pharmaceuticals
  • OTC products
  • Cosmetic formulations

Strengths and Competitive Advantages

1. Focused R&D Efforts

IGI Labs has demonstrated a strong commitment to research and development, particularly in the area of topical generic pharmaceuticals. This focused approach allows the company to build expertise and potentially gain a competitive edge in this specific market segment.

2. ANDA Submissions

As of 2013, IGI Labs had submitted eleven Abbreviated New Drug Applications (ANDAs) to the U.S. Food and Drug Administration (FDA)[3]. This aggressive pursuit of ANDAs indicates the company's commitment to expanding its product portfolio and market presence.

3. Market Opportunity

The company estimated that its eleven ANDA submissions represented a combined addressable market of approximately $250 million based on IMS data in 2013[3]. This suggests that IGI Labs had identified significant market opportunities within its chosen niche.

4. Strategic Focus

By concentrating on topical generic pharmaceutical products, IGI Labs has positioned itself in a market segment that may have less intense competition compared to other areas of the pharmaceutical industry.

Challenges and Market Dynamics

1. Regulatory Environment

Like all pharmaceutical companies, IGI Labs faces the challenge of navigating complex regulatory requirements. The success of its business model heavily depends on obtaining FDA approvals for its ANDA submissions[3].

2. Competition

While IGI Labs has carved out a niche in topical generics, it still faces competition from other pharmaceutical companies operating in this space. The generic drug market is known for its intense price competition, which could pressure profit margins.

3. Market Size Limitations

By focusing on a specific segment of the pharmaceutical market, IGI Labs may face limitations in terms of overall market size and growth potential compared to companies with broader product portfolios.

Strategic Insights

1. Pipeline Development

IGI Labs' strategy of continuously developing and submitting ANDAs is crucial for its growth. In 2013, the company aimed to file at least six ANDAs, demonstrating its commitment to expanding its product pipeline[3].

2. Long-term Value Creation

The company views its development pipeline as the strongest organic driver for creating long-term shareholder value. This suggests a strategy focused on sustainable growth through internal product development rather than aggressive acquisitions[3].

3. Investment in R&D

IGI Labs has expressed its intention to continue investing in research and development to accelerate the growth of its pipeline. This ongoing investment is critical for maintaining competitiveness in the generic pharmaceutical market[3].

Market Trends and Industry Context

To fully understand IGI Labs' position, it's important to consider broader industry trends:

1. Growth of Generic Drugs

The global generic drug market has been growing steadily, driven by patent expirations of branded drugs and efforts to reduce healthcare costs. This trend potentially benefits companies like IGI Labs that focus on generic formulations.

2. Increasing Demand for Topical Medications

There has been a growing demand for topical medications due to their localized effects and reduced systemic side effects. This trend aligns well with IGI Labs' focus on topical formulations.

3. Regulatory Landscape

The regulatory environment for generic drugs has been evolving, with the FDA working to streamline the approval process for generic drugs. This could potentially benefit companies like IGI Labs by reducing time-to-market for new products.

Competitive Intelligence in Pharma

In the pharmaceutical industry, competitive intelligence (CI) plays a crucial role in shaping strategy and decision-making. Companies like IGI Labs can benefit from robust CI practices to stay ahead in the market.

Key Components of Pharma Competitive Intelligence:

  1. Data Gathering: Collecting information about competitors, market trends, and regulatory changes.
  2. Analysis: Transforming raw data into actionable insights.
  3. Knowledge Management: Efficiently storing and retrieving data to support decision-making[4].

Financial Performance and Metrics

While specific financial data for IGI Labs (now Teligent) is not provided in the search results, it's important to note that financial performance is a key indicator of a company's competitive position. Metrics such as revenue growth, profit margins, and return on investment are crucial for assessing a company's market strength and potential.

Future Outlook and Potential

The future success of IGI Labs (Teligent) will likely depend on several factors:

  1. Pipeline Success: The approval rate and market performance of products in its pipeline.
  2. Market Expansion: Ability to expand into new geographic markets or therapeutic areas.
  3. Operational Efficiency: Maintaining cost-effectiveness in manufacturing and R&D.
  4. Regulatory Compliance: Continued success in navigating the complex regulatory landscape.

Key Takeaways

  • IGI Labs Inc (now Teligent) has positioned itself as a niche player in the generic topical pharmaceutical market.
  • The company's focused R&D efforts and aggressive ANDA submission strategy are key strengths.
  • Challenges include navigating regulatory requirements and competing in a price-sensitive generic drug market.
  • The company's future success depends on pipeline development, market expansion, and operational efficiency.
  • Competitive intelligence plays a crucial role in shaping strategy in the pharmaceutical industry.

FAQs

  1. What is IGI Labs' primary focus in the pharmaceutical market? IGI Labs (now Teligent) primarily focuses on developing and manufacturing topical generic pharmaceutical products, OTC products, and cosmetic formulations.

  2. How many ANDAs had IGI Labs submitted as of 2013? As of 2013, IGI Labs had submitted eleven Abbreviated New Drug Applications (ANDAs) to the FDA.

  3. What is the significance of ANDA submissions for pharmaceutical companies? ANDA submissions are crucial for generic drug manufacturers as they seek FDA approval to market generic versions of brand-name drugs, potentially opening up new revenue streams.

  4. How does IGI Labs view its development pipeline in terms of value creation? IGI Labs considers its development pipeline as the strongest organic driver for creating long-term shareholder value.

  5. What role does competitive intelligence play in the pharmaceutical industry? Competitive intelligence in pharma involves systematically gathering and analyzing data about competitors, market conditions, and regulatory environments to inform strategic decision-making and maintain a competitive edge.

Sources cited: [3] https://www.businesswire.com/news/home/20130724006579/en/IGI-Laboratories-Inc.-Announces-Eleventh-ANDA-Submission [4] https://visualping.io/blog/competitive-intelligence-in-pharma [7] https://www.prnewswire.com/news-releases/igi-laboratories-inc-announces-name-change-to-teligent-inc-300164749.html

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.