Kv Pharm Company Profile

What is the competitive landscape for KV PHARM

KV PHARM has forty-eight approved drugs.

Summary for Kv Pharm

US Patents:	0
Tradenames:	26
Ingredients:	26
NDAs:	48

Drugs and US Patents for Kv Pharm

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kv Pharm	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	085288-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Kv Pharm	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	085363-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Kv Pharm	BROMPHENIRAMINE MALEATE	brompheniramine maleate	ELIXIR;ORAL	085466-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Kv Pharm	CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET;ORAL	087164-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Kv Pharm	CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	085748-002	Jan 4, 1982		DISCN	No	No
Kv Pharm	TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES	pseudoephedrine hydrochloride; triprolidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	072758-001	Nov 25, 1991		DISCN	No	No

Expired US Patents for Kv Pharm

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kv Pharm	MICRO-K LS	potassium chloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	019561-003	Aug 26, 1988	4,259,315

Similar Applicant Names

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• Kv Pharm

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

In the highly competitive pharmaceutical industry, understanding the market position and strategic strengths of key players is crucial for business success. This analysis focuses on KV Pharmaceutical Company (KV Pharma), examining its market position, strengths, and strategic insights to provide a comprehensive view of its competitive landscape.

KV Pharmaceutical Company Overview

KV Pharmaceutical Company, founded in St. Louis, Missouri, was a specialty pharmaceutical company primarily focused on women's healthcare products[1]. The company developed, manufactured, and marketed both branded and generic prescription pharmaceutical products[1].

Historical Market Position

KV Pharma historically positioned itself as an integrated specialty pharmaceutical company with a strong focus on women's health care products[6]. The company's strategy involved developing and marketing both branded and generic prescription pharmaceuticals[1].

Key Product: Evamist

One of KV Pharma's notable products was Evamist, a transdermal estrogen therapy for treating moderate-to-severe vasomotor symptoms due to menopause[6]. This product showcased the company's commitment to women's health and its ability to bring innovative drug delivery systems to market.

Manufacturing and Distribution Capabilities

KV Pharma operated through two main subsidiaries:

1. ETHEX Corporation: Focused on generic pharmaceuticals[1].
2. Ther-Rx Corporation: Handled branded drug products[1].

This dual-subsidiary structure allowed KV Pharma to compete effectively in both the generic and branded pharmaceutical markets.

Strategic Partnerships and Collaborations

Acrux Limited Partnership

In 2008, KV Pharma significantly expanded its commercial collaboration with Australian drug delivery company Acrux[1]. This partnership aimed to:

• Incorporate Acrux's spray technology for transdermal drug delivery into up to six additional new branded products[1].
• License Evamist's regulatory data and FDA filings to Acrux for international markets[1].

"Acrux's promising transdermal spray technology creates exciting opportunities for us to further diversify Ther-Rx's therapeutic focus into new categories," stated Marc S. Hermelin, KV's Chairman of the Board and Chief Executive Officer[1].

This partnership demonstrated KV Pharma's commitment to innovation and expanding its product pipeline through strategic collaborations.

Research and Development Focus

KV Pharma's R&D efforts were primarily directed towards:

1. Developing new branded products
2. Improving existing formulations
3. Exploring innovative drug delivery systems

The company's collaboration with Acrux highlighted its interest in advanced drug delivery technologies, particularly in transdermal applications[1].

Financial Performance and Challenges

While specific financial data is limited in the provided information, it's clear that KV Pharma faced significant challenges:

• In 2009, the company suspended manufacturing and shipping of most of its products due to FDA concerns[4].
• By 2012, KV Pharma's stock was trading at very low levels, indicating financial distress[2].
• In 2013, the company underwent a Chapter 11 reorganization[3].

Reorganization and Recapitalization

In September 2013, KV Pharma successfully emerged from Chapter 11 bankruptcy with a $375 million recapitalization[3]. This process involved:

• A new $100 million credit facility
• A $275 million rights offering and direct purchase of new common shares
• Significant debt reduction

"As KV emerges from chapter 11 today, we are a stronger, better capitalized, and more competitive company with a solid financial foundation for future growth," said Greg Divis, CEO of KV[3].

This reorganization marked a critical turning point for KV Pharma, potentially strengthening its market position and competitive stance.

Regulatory Compliance and Quality Control

KV Pharma faced significant regulatory challenges, which impacted its market position:

• In 2009, the company voluntarily suspended manufacturing and shipping of most products due to FDA concerns[4].
• The company worked with Lachman Consultant Services to review manufacturing and packaging processes[4].

These actions highlight the importance of regulatory compliance and quality control in the pharmaceutical industry, as well as KV Pharma's efforts to address these critical issues.

Competitive Strengths

Despite its challenges, KV Pharma demonstrated several competitive strengths:

1. Focus on Women's Health: The company's specialization in women's healthcare products provided a clear market niche[6].

2. Diverse Product Portfolio: KV Pharma's ability to develop and market both branded and generic products offered flexibility in market approach[1].

3. Innovative Drug Delivery Systems: Partnerships like the one with Acrux showcased KV Pharma's commitment to advanced drug delivery technologies[1].

4. Manufacturing Capabilities: Prior to its challenges, KV Pharma had significant in-house manufacturing capabilities[1][4].

5. Strategic Partnerships: The company demonstrated an ability to form valuable collaborations to enhance its product pipeline[1].

Market Challenges and Weaknesses

KV Pharma faced several significant challenges:

1. Regulatory Issues: The FDA-related manufacturing suspension in 2009 severely impacted the company's operations and reputation[4].

2. Financial Instability: The company's bankruptcy and subsequent reorganization in 2013 indicated significant financial difficulties[3].

3. Product Recalls: KV Pharma had to conduct voluntary recalls of most of its products, which likely affected market trust and financial performance[4].

4. Competitive Pressure: The pharmaceutical industry's highly competitive nature, especially in generic products, posed ongoing challenges for KV Pharma.

Strategic Insights

Based on the available information, several strategic insights emerge for KV Pharma and similar companies in the pharmaceutical industry:

1. Regulatory Compliance is Paramount: The importance of maintaining strict quality control and regulatory compliance cannot be overstated. KV Pharma's experience demonstrates how regulatory issues can severely impact a company's operations and market position.

2. Diversification Can Provide Stability: KV Pharma's dual focus on branded and generic products could have provided some stability, although it wasn't enough to prevent financial difficulties.

3. Strategic Partnerships are Valuable: Collaborations, like the one with Acrux, can enhance a company's product pipeline and technological capabilities.

4. Specialization Can Create Market Opportunities: KV Pharma's focus on women's health provided a clear market niche, which could be leveraged for competitive advantage.

5. Financial Health is Crucial: The pharmaceutical industry requires significant capital for R&D, manufacturing, and regulatory compliance. Maintaining financial stability is essential for long-term success.

6. Innovation in Drug Delivery: KV Pharma's interest in advanced drug delivery systems, such as transdermal sprays, highlights the potential for innovation beyond just new chemical entities.

7. Rebuilding After Crisis: KV Pharma's emergence from bankruptcy demonstrates that with proper restructuring and recapitalization, pharmaceutical companies can potentially recover from severe setbacks.

Industry Implications

KV Pharma's journey offers several lessons for the broader pharmaceutical industry:

1. Quality Control: Stringent quality control measures are non-negotiable in pharmaceutical manufacturing.

2. Regulatory Relationships: Maintaining positive relationships with regulatory bodies like the FDA is crucial for sustained operations.

3. Financial Management: Proper financial management and planning are essential, especially given the high costs associated with drug development and regulatory compliance.

4. Market Adaptability: Companies need to be able to adapt to changing market conditions and regulatory landscapes quickly.

5. Innovation Focus: Continuous innovation, not just in new drugs but also in delivery systems and manufacturing processes, is vital for maintaining competitiveness.

Future Outlook for Similar Companies

For companies in similar positions to KV Pharma, the future outlook depends on several factors:

1. Regulatory Compliance: Maintaining strict adherence to regulatory standards will be crucial for avoiding operational disruptions.

2. Financial Stability: Ensuring robust financial health to weather market fluctuations and invest in R&D will be key.

3. Strategic Partnerships: Collaborations can provide access to new technologies, markets, and resources.

4. Niche Focus: Specializing in specific therapeutic areas or patient populations can create unique market opportunities.

5. Innovation Pipeline: Continuous investment in R&D and innovation will be necessary to stay competitive.

6. Adaptability: The ability to quickly adapt to changing market conditions and regulatory requirements will be essential.

Key Takeaways

1. KV Pharmaceutical Company faced significant challenges, including regulatory issues and financial instability, leading to a Chapter 11 reorganization in 2013.

2. The company's focus on women's health products and innovative drug delivery systems were key strengths.

3. Strategic partnerships, such as the collaboration with Acrux, played a crucial role in expanding KV Pharma's product pipeline.

4. Regulatory compliance and quality control are paramount in the pharmaceutical industry, as demonstrated by KV Pharma's manufacturing suspension in 2009.

5. The company's dual focus on branded and generic products provided some market flexibility.

6. KV Pharma's experience highlights the importance of financial stability, regulatory compliance, and continuous innovation in the pharmaceutical industry.

7. The company's reorganization and recapitalization in 2013 demonstrate the potential for recovery even after significant setbacks.

FAQs

1. What was KV Pharmaceutical Company's primary focus? KV Pharmaceutical Company primarily focused on women's healthcare products, developing and marketing both branded and generic prescription pharmaceuticals.

2. What were some of KV Pharma's key products? One of KV Pharma's notable products was Evamist, a transdermal estrogen therapy for treating moderate-to-severe vasomotor symptoms associated with menopause.

3. How did KV Pharma's partnership with Acrux benefit the company? The partnership with Acrux allowed KV Pharma to incorporate innovative transdermal spray technology into new branded products and expand its product pipeline.

4. What major challenges did KV Pharmaceutical face? KV Pharma faced significant regulatory challenges, including a manufacturing suspension in 2009, and financial difficulties leading to a Chapter 11 reorganization in 2013.

5. How did KV Pharmaceutical emerge from its financial difficulties? In September 2013, KV Pharma successfully emerged from Chapter 11 bankruptcy with a $375 million recapitalization, including a new credit facility and rights offering.

Sources cited: [1] https://www.biospace.com/kv-pharmaceutical-company-signs-expanded-worldwide-partnership-with-acrux-limited-including-the-development-of-six-new-branded-products [2] https://www.investing.com/equities/k-v-pharmaceutical-comp-a [3] https://www.biospace.com/kv-pharmaceutical-completes-reorganization-and-successfully-emerges-from-chapter-11-with-375-million-recapitalization [4] https://www.fiercebiotech.com/biotech/kv-pharmaceutical-suspends-product-manufacturing-shipping [6] https://www.marketbeat.com/stocks/OTCMKTS/KVPHQ/