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Last Updated: February 15, 2025

Noden Pharma Company Profile


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Summary for Noden Pharma
International Patents:72
US Patents:14
Tradenames:3
Ingredients:3
NDAs:4

Drugs and US Patents for Noden Pharma

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-001 Jan 18, 2008 DISCN Yes No 8,618,172 ⤷  Try for Free Y ⤷  Try for Free
Noden Pharma GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes 10,973,811 ⤷  Try for Free ⤷  Try for Free
Noden Pharma GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes 10,857,095 ⤷  Try for Free ⤷  Try for Free
Noden Pharma GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes 10,933,060 ⤷  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

Expired US Patents for Noden Pharma

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-001 Jan 18, 2008 9,023,893 ⤷  Try for Free
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-004 Jan 18, 2008 9,023,893 ⤷  Try for Free
Noden Pharma TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985-001 Mar 5, 2007 5,559,111*PED ⤷  Try for Free
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-004 Jan 18, 2008 5,559,111*PED ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for NODEN PHARMA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 150 mg and 300 mg ➤ Subscribe 2013-12-13
➤ Subscribe Tablets 150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg, 300 mg/25 mg ➤ Subscribe 2014-03-07

Supplementary Protection Certificates for Noden Pharma Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1602370 132009901728448 Italy ⤷  Try for Free PRODUCT NAME: (ALISKIREN EMIFUMARATO/IDROCLOROTIAZIDE(RASILEZ HCT); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/08/491/001 A EU/1/08/491/080, 20090116
1507558 122012000031 Germany ⤷  Try for Free PRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 1), AMLODIPIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 2) UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 3); NAT. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: SCHWEIZ 61678 01 - 05 20110705
0678503 C300296 Netherlands ⤷  Try for Free PRODUCT NAME: ALISKIREN OF EEN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
1507558 113 5008-2012 Slovakia ⤷  Try for Free PRODUCT NAME: ALISKIREN / AMLODIPIN / HYDROCHLORTIAZID; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - EU/1/11/730/060 20111122; FIRST REGISTRATION: CH 61678 01 - 61678 05 20110705
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Noden Pharma Market Analysis and Financial Projection

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

In the dynamic world of pharmaceuticals, understanding the competitive landscape is crucial for success. Today, we'll dive deep into Noden Pharma, a global specialty pharmaceutical company that has carved out a unique position in the market. Let's explore Noden's market position, strengths, and strategic insights to gain a comprehensive understanding of its place in the pharmaceutical industry.

Noden Pharma: An Overview

Noden Pharma DAC is a specialty pharmaceutical company based in Dublin, Ireland[7]. The company focuses on acquiring, developing, and commercializing prescription medicines across various therapeutic areas[1]. This strategic approach allows Noden to build a diverse portfolio of products, catering to different medical needs.

Key Products and Focus Areas

Noden Pharma's flagship products are Tekturna® and Tekturna HCT® (known as Rasilez® and Rasilez HTC® outside the United States)[2][4]. These medications contain aliskiren, a direct renin inhibitor used for treating hypertension. This focus on cardiovascular health positions Noden in a critical therapeutic area, given the global prevalence of hypertension.

Market Position and Global Presence

Noden Pharma has established a significant global presence, with its products available in 13 countries worldwide[7]. This international reach is a testament to the company's strategic expansion efforts and the demand for its products in various markets.

U.S. Market Penetration

The United States represents a crucial market for Noden Pharma. In 2018, major wholesale distributors like Amerisource Bergen Corporation, McKesson Corporation, and Cardinal Health, Inc. accounted for substantial portions of Noden's total net pharmaceutical sales[2]. This strong presence in the U.S. market is particularly advantageous, given that the U.S. is the world's largest pharmaceutical market with a projected growth of about 5% per annum from 2022 to 2027[8].

Competitive Landscape

Noden Pharma operates in a highly competitive environment, particularly in the hypertension treatment sector. Its products compete against various classes of treatments, including:

  • Thiazide diuretics
  • ACE inhibitors (ACEIs)
  • Angiotensin receptor blockers (ARBs)
  • Calcium channel blockers
  • Cardioselective beta blockers
  • Alpha blockers
  • Direct vasodilators
  • Centrally acting agents[2]

This diverse range of competitors underscores the importance of Noden's strategic positioning and the unique value proposition of its products.

Strengths and Competitive Advantages

1. Focused Product Portfolio

Noden Pharma's concentrated focus on specific therapeutic areas, particularly hypertension, allows for specialized expertise and targeted marketing efforts. This focus can lead to stronger brand recognition and customer loyalty within these niches.

2. Global Distribution Network

The company has established a robust distribution network that includes the EU, Switzerland, and Japan, with plans for expansion into China[2]. This global reach provides diversification and multiple revenue streams, reducing dependence on any single market.

3. Strategic Acquisitions

Noden Pharma's business model, which includes acquiring prescription medicines, allows for rapid expansion of its product portfolio. This approach can be more cost-effective and less risky than developing new drugs from scratch.

4. Authorized Generic Strategy

In response to potential generic competition in the U.S., Noden partnered with Prasco Laboratories to commercialize an authorized generic of Tekturna®[2]. This proactive approach demonstrates the company's adaptability and strategic thinking in maintaining market share.

Strategic Insights and Future Outlook

Emphasis on Mature Products

Noden Pharma's strategy aligns with a growing trend in the pharmaceutical industry:

"We are convinced that mature products with a proven long-term efficacy and safety profile, while offering a very attractive cost/effectiveness ratio, are entitled to a second life, whether in the French market or in other markets where innovation at any price is not always possible."[6]

This approach of focusing on established products with proven track records can be particularly effective in markets where cost-effectiveness is a primary concern.

Quality and Ethics Focus

Noden Pharma places a strong emphasis on quality and ethics, prioritizing French and European production[6]. This commitment to quality can be a significant differentiator in a market where drug safety and efficacy are paramount.

Agility and Responsiveness

The company prides itself on its ability to remain responsive in a dynamic world, offering pragmatic solutions[6]. This agility can be a crucial advantage in the fast-paced pharmaceutical industry, allowing Noden to adapt quickly to market changes and regulatory shifts.

Challenges and Opportunities

Generic Competition

The entry of generic competitors is a significant challenge for Noden Pharma, particularly for its flagship products. However, the company's proactive approach with authorized generics demonstrates its ability to navigate this challenge.

Expanding Therapeutic Areas

While Noden's focus on hypertension has been successful, there may be opportunities to expand into related therapeutic areas. This could provide additional growth avenues and diversify the company's portfolio further.

Emerging Markets

With plans for expansion into China and potentially other emerging markets, Noden Pharma has significant growth opportunities. However, navigating the regulatory landscapes and market dynamics of these new territories will be crucial for success.

Financial Performance and Ownership

In September 2020, Stanley Capital Partners acquired Noden Pharma[7]. This acquisition has provided Noden with additional resources and strategic support for its growth initiatives.

The acquisition deal was valued at up to $52.83 million in cash[4], indicating the perceived value and potential of Noden Pharma in the market. In October 2022, Stanley Capital Partners announced the realization of their investment in Noden Pharma, achieving a 6.7x return and a 151% IRR[9]. This impressive return on investment underscores the success of Noden Pharma's business model and market strategy.

Competitive Intelligence Strategies

To maintain and improve its market position, Noden Pharma likely employs various competitive intelligence strategies:

1. Product Portfolio Analysis

Regularly analyzing competitors' product portfolios, including pipeline products, helps Noden identify potential threats and opportunities in the market[5].

2. Patent Landscape Assessment

Monitoring competitors' patent portfolios and expiration dates is crucial in the pharmaceutical industry. This information can help Noden identify potential opportunities for new generic entries or areas where they might face increased competition[5].

3. Regulatory Strategy Analysis

Understanding how competitors navigate the complex regulatory landscape can provide valuable insights. This includes analyzing approaches to clinical trials, regulatory submissions, and market access strategies[5].

4. Financial Performance Evaluation

Analyzing the financial health and performance of competitors can provide insights into their strategic priorities and potential future moves[5].

5. Social Media Monitoring

In today's digital age, monitoring competitors' social media activities can provide insights into their marketing strategies, product launches, and potential issues they might be facing[5].

Key Takeaways

  1. Noden Pharma is a specialty pharmaceutical company focusing on acquiring, developing, and commercializing prescription medicines, with a strong presence in the hypertension treatment market.

  2. The company has a global presence, with products available in 13 countries and a significant market share in the United States.

  3. Noden's strategic focus on mature products with proven efficacy and safety profiles sets it apart in the competitive pharmaceutical landscape.

  4. The company faces challenges from generic competition but has demonstrated agility in addressing these threats through strategies like authorized generics.

  5. Noden Pharma's acquisition by Stanley Capital Partners in 2020 and subsequent successful exit in 2022 underscores the company's strong market position and growth potential.

  6. Competitive intelligence strategies, including product portfolio analysis, patent landscape assessment, and regulatory strategy analysis, are crucial for maintaining Noden's competitive edge.

  7. Future opportunities for Noden include expansion into emerging markets and potential diversification into related therapeutic areas.

FAQs

  1. What are Noden Pharma's main products? Noden Pharma's flagship products are Tekturna® and Tekturna HCT® (known as Rasilez® and Rasilez HTC® outside the United States), which contain aliskiren for treating hypertension.

  2. How does Noden Pharma compete against generic competitors? Noden has employed strategies such as partnering with Prasco Laboratories to commercialize an authorized generic of Tekturna®, demonstrating proactive measures to maintain market share.

  3. What is Noden Pharma's global presence? Noden Pharma's products are available in 13 countries globally, with a strong presence in the United States and distribution networks in the EU, Switzerland, and Japan.

  4. Who owns Noden Pharma? Noden Pharma was acquired by Stanley Capital Partners in September 2020, who then successfully exited their investment in October 2022.

  5. What competitive intelligence strategies might Noden Pharma use? Noden likely employs strategies such as product portfolio analysis, patent landscape assessment, regulatory strategy analysis, financial performance evaluation, and social media monitoring to maintain its competitive edge.

Sources cited:

  1. https://directory.startupluxembourg.com/companies/noden_pharma
  2. https://www.annualreports.com/HostedData/AnnualReportArchive/p/NASDAQ_PDLI_2018.pdf
  3. https://www.pdl.com/news-releases/news-release-details/pdl-biopharma-completes-divestiture-noden-pharmaceutical
  4. https://www.drugpatentwatch.com/blog/the-importance-of-pharmaceutical-competitor-analysis/
  5. https://lxogroup.com/en/our-groupe/
  6. https://www.metric-capital.com/project/noden-pharma/
  7. https://smart-pharma.com/wp-content/uploads/2023/11/Pharma-Corporate-Strategy-Insights-VF.pdf
  8. https://stanley-capital.com/news-and-insights/

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