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Last Updated: April 19, 2025

Par Pharm Company Profile


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Summary for Par Pharm

Drugs and US Patents for Par Pharm

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Par Pharm AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 088700-001 Sep 25, 1984 DISCN No No ⤷  Try for Free ⤷  Try for Free
Par Pharm DOXY-SLEEP-AID doxylamine succinate TABLET;ORAL 070156-001 Jul 2, 1987 DISCN No No ⤷  Try for Free ⤷  Try for Free
Par Pharm HYDRO-RIDE amiloride hydrochloride; hydrochlorothiazide TABLET;ORAL 070347-001 Dec 25, 1990 DISCN No No ⤷  Try for Free ⤷  Try for Free
Par Pharm HYDROXYZINE PAMOATE hydroxyzine pamoate CAPSULE;ORAL 089146-001 Mar 17, 1986 DISCN No No ⤷  Try for Free ⤷  Try for Free
Par Pharm LEUCOVORIN CALCIUM leucovorin calcium TABLET;ORAL 071598-001 Oct 14, 1987 DISCN No No ⤷  Try for Free ⤷  Try for Free
Par Pharm PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; perphenazine TABLET;ORAL 070595-001 Sep 11, 1986 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 6 of 6 entries

International Patents for Par Pharm Drugs

CountryPatent NumberEstimated Expiration
Australia 2006240490 ⤷  Try for Free
Japan 5378788 ⤷  Try for Free
Japan 2008538560 ⤷  Try for Free
Mexico 2007013118 ⤷  Try for Free
South Korea 20080000660 ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2006115626 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration
Showing 1 to 6 of 6 entries

Supplementary Protection Certificates for Par Pharm Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
0454511 99C0009 Belgium ⤷  Try for Free PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
1769785 C300521 Netherlands ⤷  Try for Free PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1769785 C300522 Netherlands ⤷  Try for Free PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0901368 C300523 Netherlands ⤷  Try for Free PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0836511 CA 2006 00019 Denmark ⤷  Try for Free PRODUCT NAME: FENTANYL HYDROCHLORID
1781277 PA2024501 Lithuania ⤷  Try for Free PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 6 of 6 entries
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: PAR PHARM – Market Position, Strengths & Strategic Insights

Par Pharmaceutical, a subsidiary of Endo International plc, has established itself as a significant player in the U.S. generics industry. With a diverse portfolio and strong market presence, Par Pharm has become one of the top leaders in the pharmaceutical landscape[2]. This article delves into Par Pharm's market position, strengths, and strategic insights, providing a comprehensive analysis of its competitive landscape.

Company Overview

Par Pharmaceutical, headquartered in Chestnut Ridge, New York, is a specialty pharmaceutical company that develops, manufactures, and markets safe, innovative, and cost-effective generic pharmaceutical and branded injectable products[2]. As an operating company of Endo International plc, Par Pharm has positioned itself as a highly focused generics and specialty branded pharmaceutical company[2].

Market Position

Par Pharmaceutical has solidified its position as one of the top leaders in the U.S. generics industry[2]. This standing is attributed to several factors:

Diverse Product Portfolio

Par Pharm boasts a robust portfolio that includes:

  • Sterile injectables
  • Alternative dosage forms
  • Differentiated products[2]

This diverse range of offerings allows Par Pharm to cater to various market segments and maintain a competitive edge.

Strategic Acquisition

In 2015, Endo International plc acquired Par Pharmaceutical in a transaction valued at $8.05 billion, including the assumption of Par debt[1]. This strategic move reshaped the generic pharmaceuticals landscape and transformed Endo's platform for future growth[1].

"This is an exciting time of growth and opportunity in the generics and specialty pharmaceutical arenas. Par Pharmaceutical is committed to significantly expanding our scope, capacity and capabilities to realize the maximum value of our rich and diversified product portfolio and R&D pipeline." - Mr. Campanelli, CEO of Par Pharmaceutical[1]

Market Share Growth

Following the acquisition by Endo, Par Pharm's generics business unit was expected to become one of the largest and fastest-growing in the industry, with double-digit revenue growth over the long term[1].

Strengths and Competitive Advantages

Par Pharmaceutical's competitive landscape is characterized by several key strengths:

1. Robust R&D Pipeline

Par Pharm offers a solid pipeline consisting of more than 200 Abbreviated New Drug Applications (ANDAs), with 115 filed with the U.S. Food and Drug Administration (FDA) as of December 31, 2014[1]. This extensive pipeline provides a strong foundation for future growth and market expansion.

2. First-to-File Opportunities

Approximately 33% of Par Pharm's filed ANDAs are potential first-to-file or first-to-market opportunities[1]. This strategic positioning allows the company to potentially secure periods of market exclusivity, providing a significant competitive advantage.

3. High-Barrier-to-Entry Products

Par Pharmaceutical's portfolio includes many high-barrier-to-entry products[2]. These products typically face less competition due to the complexity of their development or manufacturing processes, allowing Par Pharm to maintain higher profit margins.

4. Operational Excellence

Par Pharm's commitment to operational excellence is evident in its ability to develop, manufacture, and market high-quality, cost-effective pharmaceutical products[2]. This focus on efficiency and quality contributes to the company's competitive edge.

5. Strategic Partnerships

Par Pharmaceutical has engaged in strategic partnerships and licensing agreements to expand its product offerings and market reach. For example, the company has a licensing and commercialization agreement for generic Focalin XR®, which provides quarterly profit-share payments on U.S. sales[7].

Strategic Insights

To maintain and enhance its competitive position, Par Pharmaceutical employs several strategic approaches:

Product Development Strategy

Par Pharm focuses on developing generic drugs in areas of greatest revenue potential, complex formulations, and longer life cycles[1]. This strategy allows the company to target high-value market segments and maintain a competitive advantage.

R&D Investment

The company has refocused its investments in R&D, aiming to generate approximately 20 to 25 ANDA filings each year from 2015 to 2017[1][4]. This commitment to innovation ensures a steady pipeline of new products to drive future growth.

Market Expansion

Par Pharmaceutical has pursued market expansion through various means:

  1. Launching new product strengths to improve revenues[7]
  2. Entering new strategic segments such as sterile injectables and alternative dosage forms[2]
  3. Leveraging its position as a first-filer for certain generic products to secure periods of market exclusivity[7]

Operational Efficiency

Par Pharm has strengthened its processes and controls, demonstrating a commitment to operational excellence[4]. This focus on efficiency helps maintain competitiveness in the challenging generics market.

Strategic Acquisitions

As evidenced by its acquisition by Endo International, Par Pharmaceutical recognizes the value of strategic acquisitions in expanding its market presence and capabilities[1].

Competitive Landscape Analysis

To fully understand Par Pharmaceutical's position in the market, it's essential to conduct a comprehensive competitive landscape analysis:

1. PESTEL Analysis

A PESTEL analysis can provide insights into the macro-environmental factors affecting Par Pharm and the pharmaceutical industry as a whole[5]:

  • Political: Government policies on healthcare and drug pricing
  • Economic: Economic conditions affecting healthcare spending
  • Social: Changing demographics and health trends
  • Technological: Advancements in drug development and manufacturing
  • Environmental: Sustainability concerns in pharmaceutical production
  • Legal: Regulatory requirements and patent laws

2. Porter's Five Forces Analysis

Applying Porter's Five Forces framework to Par Pharmaceutical's competitive landscape reveals:

  • Supplier Power: Moderate, due to the availability of raw materials and manufacturing capabilities
  • Buyer Power: High, with increasing pressure from payers and healthcare providers
  • Threat of New Entrants: Moderate, due to high barriers to entry in complex generics
  • Threat of Substitutes: Moderate, with potential competition from biosimilars and new treatment modalities
  • Competitive Rivalry: High, in the crowded generics market[5]

3. Competitor Analysis

Key components of a competitor analysis for Par Pharmaceutical include:

  • Product Portfolio and Market Share: Comparing Par Pharm's offerings with those of other generic manufacturers
  • R&D Pipeline: Assessing the strength and potential of competitors' drug development programs
  • Financial Data: Analyzing revenue trends, profitability, and R&D expenditure of major players
  • Marketing Strategies: Examining how competitors position their products and engage with stakeholders
  • Regulatory Compliance: Evaluating competitors' track records with FDA approvals and quality control[5]

Market Access Strategy

Par Pharmaceutical's success in the competitive landscape also depends on its market access strategy. Key considerations include:

  • Pricing strategies to balance competitiveness and profitability
  • Relationships with payers, pharmacy benefit managers, and healthcare providers
  • Patient access programs to ensure affordability and availability of medications
  • Regulatory compliance and quality assurance to maintain market access[6]

Future Outlook

The future of Par Pharmaceutical in the competitive landscape looks promising, driven by:

  1. Continued focus on high-value generic products
  2. Expansion of its sterile injectables and alternative dosage form offerings
  3. Leveraging its robust R&D pipeline to bring new products to market
  4. Potential for further strategic acquisitions or partnerships to enhance capabilities and market reach

Key Takeaways

  • Par Pharmaceutical, a subsidiary of Endo International plc, is a top leader in the U.S. generics industry.
  • The company's strengths include a diverse product portfolio, robust R&D pipeline, and focus on high-barrier-to-entry products.
  • Strategic insights reveal a focus on product development in high-value areas, continued R&D investment, and market expansion.
  • Competitive landscape analysis highlights the importance of adapting to macro-environmental factors and understanding competitor dynamics.
  • Par Pharm's future outlook is positive, driven by its focus on high-value generics and potential for further strategic growth.

FAQs

  1. What makes Par Pharmaceutical a leader in the U.S. generics industry? Par Pharmaceutical's leadership position is attributed to its diverse product portfolio, including sterile injectables and alternative dosage forms, as well as its focus on high-barrier-to-entry products and robust R&D pipeline.

  2. How has the acquisition by Endo International impacted Par Pharmaceutical's market position? The acquisition has strengthened Par Pharm's market position by expanding its scope, capacity, and capabilities. It has also positioned the company for faster growth and increased its potential for future M&A activities.

  3. What is Par Pharmaceutical's strategy for maintaining competitiveness in the generics market? Par Pharm focuses on developing generic drugs in areas of greatest revenue potential, complex formulations, and longer life cycles. The company also invests heavily in R&D and pursues strategic partnerships and market expansion opportunities.

  4. How does Par Pharmaceutical leverage its R&D pipeline for competitive advantage? Par Pharm's R&D pipeline includes many potential first-to-file or first-to-market opportunities, which can provide periods of market exclusivity. The company aims to generate 20-25 ANDA filings annually, ensuring a steady stream of new products.

  5. What are the key challenges Par Pharmaceutical faces in the current competitive landscape? Key challenges include intense competition in the generics market, pricing pressures from payers and healthcare providers, regulatory hurdles, and the need to continuously innovate and develop complex generic products to maintain a competitive edge.

Sources cited:

  1. https://investor.endo.com/2015-05-18-Endo-to-Acquire-Par-Pharmaceutical,-Strategically-Expanding-Generics-Business-to-a-Top-5-Industry-Leader
  2. https://leadiq.com/c/par-pharmaceutical/5a1d95e52300005b00848716
  3. https://www.biospace.com/par-pharmaceutical-companies-inc-provides-summary-of-analyst-investor-day
  4. https://www.infinitiresearch.com/thoughts/steps-competitor-analysis-pharma-companies/
  5. https://www.mmitnetwork.com/thought-leadership/market-access-101-understanding-the-basics/
  6. https://www.biospace.com/intellipharmaceutics-reports-on-launch-of-additional-strengths-of-generic-focalin-xr-by-par-pharma-758216

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