You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: May 23, 2025

Caraco Company Profile


✉ Email this page to a colleague

« Back to Dashboard


What is the competitive landscape for CARACO

CARACO has three approved drugs.

There are three tentative approvals on CARACO drugs.

Summary for Caraco
US Patents:0
Tradenames:2
Ingredients:2
NDAs:3

Drugs and US Patents for Caraco

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Caraco HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 090265-003 Dec 23, 2008 DISCN No No ⤷  Try for Free ⤷  Try for Free
Caraco WYGESIC acetaminophen; propoxyphene hydrochloride TABLET;ORAL 084999-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free
Caraco HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 090265-002 Dec 23, 2008 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
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Caraco – Market Position, Strengths & Strategic Insights

In the dynamic world of pharmaceuticals, understanding the competitive landscape is crucial for success. This analysis focuses on Caraco Pharmaceutical Laboratories, Ltd., a Detroit-based company that has made significant strides in the generic pharmaceutical market. Let's dive into Caraco's market position, strengths, and strategic insights to gain a comprehensive understanding of its role in the industry.

Company Overview

Caraco Pharmaceutical Laboratories, Ltd., established in 1984 and based in Detroit, Michigan, has been a key player in the generic pharmaceutical industry[10]. The company specializes in developing, manufacturing, marketing, and distributing generic pharmaceuticals to major wholesalers, distributors, drugstore chains, and managed care providers across the United States[1][2].

Core Business Activities

Caraco's primary focus lies in the generic pharmaceutical sector, where it has built a reputation for providing affordable alternatives to branded drugs. The company's operations span various aspects of the pharmaceutical value chain, including:

  1. Research and Development
  2. Manufacturing
  3. Marketing
  4. Distribution

This integrated approach allows Caraco to maintain control over its product lifecycle and respond quickly to market demands.

Market Position

Caraco has established a significant presence in the U.S. generic pharmaceutical market. While exact market share figures are not provided in the search results, we can infer the company's position based on available information.

Growth and Recognition

In 2007, Caraco was recognized as one of the fastest-growing technology, media, telecommunications, and life sciences companies in North America[4]. The company ranked in the top 500 on Deloitte's 2007 Technology Fast 500, with an impressive 270% revenue growth over five years (2002-2006)[4].

"We are honored to receive this ranking and feel it is an indication of the hard work and dedication of the Caraco team and the growth of our portfolio of products developed and approved for the US market." - Daniel H. Movens, CEO of Caraco[4]

This recognition highlights Caraco's strong market performance and rapid expansion during that period.

Market Reach

Caraco's products reach a wide array of customers, including:

  • Largest wholesalers
  • Major distributors
  • Drugstore chains
  • Managed care providers[1][2]

This broad distribution network underscores the company's significant market penetration and its ability to compete effectively in the generic pharmaceutical space.

Product Portfolio

Caraco's product portfolio is diverse, covering various therapeutic areas. While specific product details are limited in the search results, we can highlight some key aspects of their offerings.

Generic Optivar

One notable product in Caraco's portfolio is the generic version of Optivar[2]. This demonstrates the company's capability to produce and market complex generic formulations, competing directly with established branded drugs.

Therapeutic Areas

While comprehensive information on all therapeutic areas is not provided, we can infer that Caraco's portfolio likely includes drugs for common conditions such as:

  • Cardiovascular diseases
  • Central nervous system disorders
  • Pain management
  • Respiratory conditions

This diverse range of products allows Caraco to cater to various medical needs and maintain a competitive edge in multiple market segments.

Manufacturing Capabilities

Caraco's manufacturing capabilities have been a crucial aspect of its operations, though they have faced challenges in recent years.

Manufacturing Facilities

The company operated manufacturing facilities in:

  1. Detroit, Michigan
  2. Farmington, Michigan
  3. Wixom, Michigan[5]

These facilities were responsible for producing a significant portion of Caraco's generic drug portfolio.

Regulatory Challenges

In 2009, Caraco faced a major setback when the U.S. Food and Drug Administration (FDA) directed U.S. Marshals to seize drugs manufactured at these facilities[5]. This action was due to quality violations and followed a warning letter issued against the Detroit facility earlier that year.

The FDA also issued a directive for Caraco to stop distribution of drugs from these facilities until further notice[5]. This development significantly impacted Caraco's operations and market position.

Strategic Partnerships

One of Caraco's key strengths lies in its strategic partnerships, particularly its relationship with Sun Pharmaceutical Industries Limited.

Sun Pharma Acquisition

In 2011, Caraco entered into a merger agreement with Sun Pharmaceutical Industries Limited (Sun Pharma) and its subsidiaries[1]. At the time of the merger, Sun Pharma and its subsidiary Sun Global collectively owned 75.8% of Caraco's common stock[1].

This merger provided Caraco with:

  1. Access to Sun Pharma's extensive resources
  2. Enhanced research and development capabilities
  3. Expanded global reach
  4. Improved manufacturing expertise

Impact on Market Position

The merger with Sun Pharma significantly strengthened Caraco's market position. As part of a larger pharmaceutical conglomerate, Caraco gained:

  • Increased financial stability
  • Access to a broader product portfolio
  • Enhanced ability to navigate regulatory challenges
  • Improved competitive stance against other major generic drug manufacturers

Research and Development

While specific details about Caraco's R&D activities are limited in the search results, we can infer that the company has invested significantly in this area to maintain its competitive edge.

Focus on Innovation

As a generic drug manufacturer, Caraco's R&D efforts likely concentrate on:

  1. Developing bioequivalent formulations of branded drugs
  2. Improving existing generic formulations for better efficacy or reduced side effects
  3. Exploring new drug delivery systems
  4. Expanding into new therapeutic areas

Patent Challenges

A crucial aspect of Caraco's R&D strategy would involve identifying opportunities for challenging patents of branded drugs. This approach, known as "patent busting," allows generic manufacturers to bring their products to market sooner, potentially capturing significant market share.

Competitive Advantages

Despite facing regulatory challenges, Caraco has maintained several competitive advantages in the generic pharmaceutical market.

Cost-Effective Manufacturing

Caraco's ability to produce generic drugs cost-effectively has been a key factor in its success. This allows the company to offer products at competitive prices while maintaining profitability.

Diverse Product Portfolio

The company's wide range of generic products across various therapeutic areas helps mitigate risks associated with market fluctuations in specific drug categories.

Strong Distribution Network

Caraco's established relationships with major wholesalers, distributors, and pharmacy chains ensure wide market reach for its products.

Backing of Sun Pharma

The merger with Sun Pharma provides Caraco with financial stability, expanded resources, and global market access, enhancing its competitive position.

Market Challenges

While Caraco has demonstrated strengths in the generic pharmaceutical market, it also faces several challenges that impact its market position.

Regulatory Scrutiny

The FDA's actions against Caraco's manufacturing facilities in 2009 highlight the intense regulatory scrutiny faced by generic drug manufacturers[5]. Maintaining compliance with Good Manufacturing Practices (GMP) is crucial for sustained success in this industry.

Intense Competition

The generic pharmaceutical market is highly competitive, with numerous players vying for market share. Caraco must continuously innovate and optimize its operations to maintain its position.

Price Pressures

Generic drug manufacturers face constant pressure to reduce prices while maintaining quality. This challenge requires efficient operations and strategic pricing decisions.

Future Outlook

Looking ahead, Caraco's future in the pharmaceutical landscape appears intertwined with that of Sun Pharma. The company's ability to leverage its parent company's resources while addressing past regulatory challenges will be crucial for its continued success.

Potential Growth Areas

  1. Expansion into new therapeutic areas
  2. Development of complex generics with higher barriers to entry
  3. Exploration of emerging markets for generic drugs
  4. Investment in biosimilars as patents for biologic drugs expire

Regulatory Compliance

Rebuilding trust with regulatory authorities and ensuring strict compliance with manufacturing standards will be paramount for Caraco's future growth.

Key Takeaways

  1. Caraco Pharmaceutical Laboratories has established a significant presence in the U.S. generic drug market, with a diverse product portfolio and strong distribution network.

  2. The company's merger with Sun Pharma in 2011 provided enhanced resources and global reach, strengthening its competitive position.

  3. Regulatory challenges, particularly the FDA actions in 2009, have impacted Caraco's operations and highlight the importance of maintaining strict quality standards.

  4. Caraco's future success depends on leveraging Sun Pharma's resources, addressing regulatory concerns, and continuing to innovate in the competitive generic drug market.

  5. The company's ability to develop cost-effective manufacturing processes and maintain a diverse product portfolio remains key to its competitive advantage.

FAQs

  1. Q: What is Caraco Pharmaceutical Laboratories' primary business focus? A: Caraco specializes in developing, manufacturing, marketing, and distributing generic pharmaceuticals to major wholesalers, distributors, drugstore chains, and managed care providers in the United States.

  2. Q: When was Caraco founded, and where is it based? A: Caraco was established in 1984 and is based in Detroit, Michigan.

  3. Q: How did the merger with Sun Pharma affect Caraco's market position? A: The merger provided Caraco with access to Sun Pharma's extensive resources, enhanced R&D capabilities, expanded global reach, and improved manufacturing expertise, significantly strengthening its market position.

  4. Q: What major regulatory challenge did Caraco face in 2009? A: In 2009, the U.S. FDA directed U.S. Marshals to seize drugs manufactured at Caraco's facilities due to quality violations and issued a directive to stop distribution from these facilities until further notice.

  5. Q: What are some key factors that contribute to Caraco's competitive advantage in the generic pharmaceutical market? A: Caraco's competitive advantages include cost-effective manufacturing, a diverse product portfolio, a strong distribution network, and the backing of Sun Pharma following their merger.

Sources cited:

  1. https://www.prnewswire.com/news-releases/caraco-announces-merger-agreement-with-sun-pharma-caraco-public-shareholders-to-receive-525-cash-per-share-116650324.html
  2. https://www.fiercepharma.com/pharma/caraco-pharmaceutical-laboratories-ltd-markets-generic-optivar%C2%AE
  3. https://www.biospace.com/caraco-pharmaceutical-laboratories-ltd-among-top-500-of-the-fastest-growing-companies-in-north-america
  4. https://www.spglobal.com/marketintelligence/en/mi/country-industry-forecasting.html?id=106595376
  5. https://www.sec.gov/Archives/edgar/data/887708/000116923207001302/d71192_ex99-1.htm
Last updated: 2025-02-12

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

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.