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Last Updated: March 24, 2025

Metuchen Pharms Company Profile


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Summary for Metuchen Pharms
International Patents:39
US Patents:1
Tradenames:1
Ingredients:1
NDAs:1

Drugs and US Patents for Metuchen Pharms

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 AB RX Yes No ⤷  Try for Free ⤷  Try for Free
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 AB RX Yes No 6,656,935 ⤷  Try for Free Y Y ⤷  Try for Free
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 AB RX Yes No 6,656,935 ⤷  Try for Free Y Y ⤷  Try for Free
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 AB RX Yes No ⤷  Try for Free ⤷  Try for Free
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 AB RX Yes Yes 6,656,935 ⤷  Try for Free Y Y ⤷  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 Metuchen Pharms

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 7,501,409 ⤷  Try for Free
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 7,501,409 ⤷  Try for Free
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 7,501,409 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for METUCHEN PHARMS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 50 mg, 100 mg and 200 mg ➤ Subscribe 2016-04-27

Supplementary Protection Certificates for Metuchen Pharms Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1219609 122013000096 Germany ⤷  Try for Free PRODUCT NAME: AVANAFIL UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609 CA 2013 00040 Denmark ⤷  Try for Free
1219609 2013C/051 Belgium ⤷  Try for Free PRODUCT NAME: AVANAFIL; AUTHORISATION NUMBER AND DATE: EU/1/13/841 20130624
1219609 476 Finland ⤷  Try for Free
1219609 SPC/GB13/071 United Kingdom ⤷  Try for Free PRODUCT NAME: AVANAFIL; REGISTERED: UK EU/1/13/841 20130621
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: Metuchen Pharmaceuticals - Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, understanding the competitive landscape is crucial for success. This comprehensive analysis delves into Metuchen Pharmaceuticals' market position, strengths, and strategic insights, providing valuable information for industry professionals and investors alike.

Company Overview: Metuchen Pharmaceuticals

Metuchen Pharmaceuticals, LLC is a privately held biopharmaceutical company based in New Jersey, United States. Founded in 2016, the company has quickly established itself as a significant player in the men's health sector, particularly in the treatment of erectile dysfunction (ED)[1][5].

Key Product: Stendra (Avanafil)

Metuchen's cornerstone product is Stendra (avanafil), an FDA-approved medication for the treatment of erectile dysfunction. Stendra is a phosphodiesterase type 5 (PDE5) inhibitor, placing it in the same class as well-known drugs like Viagra and Cialis[2][5].

"Stendra is a unique asset in the erectile dysfunction space." - John Shulman, founder and Managing Partner of Juggernaut Capital and executive chairman of Metuchen[2]

Market Position and Competitive Landscape

The Erectile Dysfunction Market

The global erectile dysfunction drugs market is projected to grow at a CAGR of 5.22% and reach $547.57 million by 2028[4]. This growth is driven by factors such as an aging population, increasing prevalence of chronic diseases, and growing awareness about men's health issues.

Stendra's Position in the Market

While exact market share figures for Stendra are not publicly available, we can glean some insights from available data:

  1. In 2019, Stendra generated $30 million in gross revenue[2].
  2. The company is confident that Stendra can grow by about 500,000 new prescriptions per month[2].

These figures suggest that while Stendra has established a presence in the market, there's significant room for growth compared to more established competitors like Viagra and Cialis.

Strengths and Competitive Advantages

1. Focused Strategy

Metuchen Pharmaceuticals has positioned itself as a company exclusively focused on men's health conditions. This specialized approach allows for concentrated efforts and expertise in a specific therapeutic area[1][2].

2. FDA-Approved Product

Stendra's FDA approval provides a significant competitive advantage, as it validates the drug's safety and efficacy[2][7].

3. Expanded FDA Labeling

In October 2022, Stendra received expanded FDA labeling to include efficacy data for use in men who have undergone radical prostatectomy. This broadens the potential patient population for the drug[5].

4. Strategic Partnerships

Metuchen has demonstrated a willingness to engage in strategic partnerships to enhance its market position. The merger with Neurotrope to form Petros Pharmaceuticals is a prime example of this strategy[1][2].

Strategic Insights and Future Outlook

1. Aggressive Marketing Strategy

Metuchen plans to launch an aggressive ad campaign for Stendra, aiming to significantly increase prescriptions[2]. This suggests a focus on increasing brand awareness and market penetration.

2. Pipeline Expansion

The company is not relying solely on Stendra. It has plans to develop a pipeline of other therapeutic products for men's health, including a topical treatment (H-100) for Peyronie's disease[1][2].

3. Public Market Access

The merger with Neurotrope to form Petros Pharmaceuticals provides Metuchen with access to public markets. This could potentially provide easier access to capital for future growth and development[1][2].

4. Patent Protection

Stendra is protected by patents until April 2025, providing a window of exclusivity. However, the company will need to prepare for potential generic competition after this date[7].

Challenges and Potential Threats

1. Competitive Market

The erectile dysfunction market is highly competitive, with well-established players and strong brand recognition for drugs like Viagra and Cialis.

2. Regulatory Scrutiny

In 2019, Metuchen received a warning letter from the FDA regarding misbranding of Stendra[9]. This highlights the importance of strict adherence to regulatory guidelines in promotional activities.

3. Patent Expiration

With Stendra's patent set to expire in April 2025, the company will need to prepare for potential generic competition[7].

Comparative Analysis

While specific market share data for erectile dysfunction drugs is not readily available, we can compare some aspects of Stendra with its main competitors:

  1. First-to-market advantage: Viagra (sildenafil) and Cialis (tadalafil) have been on the market longer and have stronger brand recognition.

  2. Duration of action: Stendra can work in as little as 15 minutes and lasts up to 6 hours, which may be advantageous for some patients compared to other options.

  3. Side effect profile: All PDE5 inhibitors have similar side effects, but individual patient experiences may vary.

Key Takeaways

  1. Metuchen Pharmaceuticals has established itself as a focused player in the men's health sector, with its FDA-approved erectile dysfunction drug Stendra as its cornerstone product.

  2. The company has demonstrated strategic thinking through its merger with Neurotrope and plans for pipeline expansion.

  3. While Stendra has shown promise, it faces stiff competition in a market dominated by well-established brands.

  4. The upcoming patent expiration in 2025 presents a significant challenge that the company will need to address.

  5. Metuchen's future success will likely depend on its ability to increase Stendra's market share, successfully develop its pipeline, and navigate the competitive and regulatory landscape of the pharmaceutical industry.

FAQs

  1. Q: What is Metuchen Pharmaceuticals' main product? A: Metuchen Pharmaceuticals' main product is Stendra (avanafil), an FDA-approved medication for the treatment of erectile dysfunction.

  2. Q: When was Metuchen Pharmaceuticals founded? A: Metuchen Pharmaceuticals was founded in 2016.

  3. Q: What is the projected growth rate of the global erectile dysfunction drugs market? A: The global erectile dysfunction drugs market is projected to grow at a CAGR of 5.22% and reach $547.57 million by 2028.

  4. Q: When does Stendra's patent expire? A: Stendra's patent is set to expire in April 2025.

  5. Q: What other products is Metuchen Pharmaceuticals developing? A: Metuchen is developing a pipeline of other therapeutic products for men's health, including a topical treatment (H-100) for Peyronie's disease.

Sources cited:

  1. https://www.roi-nj.com/2020/05/18/healthcare/neurotrope-metuchen-pharmaceuticals-merge-to-form-a-new-mens-health-company/
  2. https://www.biospace.com/metuchen-and-neurotrope-merge-to-form-men-s-health-focused-petros-pharmaceuticals
  3. https://www.databridgemarketresearch.com/reports/global-erectile-dysfunction-drugs-market
  4. https://synapse.patsnap.com/organization/33e7d274aeece9e17c502795469a610f
  5. https://pharsight.greyb.com/drug/stendra-patent-expiration
  6. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/metuchen-pharmaceuticals-llc-590713-08162019

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