PENICILLIN V POTASSIUM - Generic Drug Details

What are the generic drug sources for penicillin v potassium and what is the scope of patent protection?

Penicillin v potassium is the generic ingredient in fourteen branded drugs marketed by Glaxosmithkline, Apothecon, Lederle, Wyeth Ayerst, Parke Davis, Belcher Pharms, Chartwell Rx, Mylan, Purepac Pharm, Teva, Pfizer, Lilly, Bristol, Aurobindo Pharma, Hikma Pharms, Ivax Sub Teva Pharms, Sandoz, and Pharmacia And Upjohn, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for penicillin v potassium. Nineteen suppliers are listed for this compound.

Summary for PENICILLIN V POTASSIUM

US Patents:	0
Tradenames:	14
Applicants:	18
NDAs:	36
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	4
Patent Applications:	3,874
Drug Prices:	Drug price trends for PENICILLIN V POTASSIUM
What excipients (inactive ingredients) are in PENICILLIN V POTASSIUM?	PENICILLIN V POTASSIUM excipients list
DailyMed Link:	PENICILLIN V POTASSIUM at DailyMed

See drug prices for PENICILLIN V POTASSIUM

See drug sales revenues for PENICILLIN V POTASSIUM

Recent Clinical Trials for PENICILLIN V POTASSIUM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Alphacait, LLC	Phase 2
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Phillip Brian Smith	Phase 1

See all PENICILLIN V POTASSIUM clinical trials

Pharmacology for PENICILLIN V POTASSIUM

Drug Class

Penicillin-class Antibacterial

US Patents and Regulatory Information for PENICILLIN V POTASSIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	PENICILLIN V POTASSIUM	penicillin v potassium	FOR SOLUTION;ORAL	061624-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Apothecon	VEETIDS '250'	penicillin v potassium	TABLET;ORAL	061164-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharmacia And Upjohn	UTICILLIN VK	penicillin v potassium	TABLET;ORAL	061651-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Apothecon	VEETIDS	penicillin v potassium	TABLET;ORAL	061411-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Chartwell Rx	PENICILLIN V POTASSIUM	penicillin v potassium	FOR SOLUTION;ORAL	062981-002	Feb 10, 1989		DISCN	No	No
Apothecon	BETAPEN-VK	penicillin v potassium	FOR SOLUTION;ORAL	061149-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	PFIZERPEN VK	penicillin v potassium	FOR SOLUTION;ORAL	061815-001	Approved Prior to Jan 1, 1982		DISCN	No	No

PENICILLIN V POTASSIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Penicillin V Potassium

Introduction

Penicillin V potassium, a potent antibiotic, has been a cornerstone in the treatment of various bacterial infections for decades. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare professionals.

Global Market Size and Growth

The global penicillin drug market, which includes Penicillin V potassium, is projected to grow significantly. By 2024, the market is expected to reach a size of over USD 9.6 billion and is anticipated to grow to more than USD 13.4 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 3.8% during this period[3].

Market Segments and Dominance

The penicillin market is segmented by source, route of administration, spectrum of activity, and distribution channel. Natural penicillin, which includes Penicillin V potassium, dominates the market due to its historical prominence, safety, and compliance with regulations. The oral route of administration leads the market due to its convenience, patient preference, and cost-effectiveness[3].

Regional Market Share

North America is projected to dominate the penicillin market with a 38.2% revenue share, driven by a well-established healthcare system, a robust pharmaceutical industry, and an informed population. This region's strong healthcare infrastructure and high demand for antibiotics contribute to its leading position[3].

Distribution Channels

Hospitals are expected to dominate the distribution channels with a 57.9% market share. This is due to dedicated pharmacies, specialized inpatient treatment, and readiness for emergencies, ensuring accurate and timely medication administration[3].

Trends and Drivers

Several trends are driving the growth of the penicillin market:

• Customized Medicinal Drugs: The trend towards customized medicinal drugs, tailored to individual patients' genetic makeup and other factors, is leading to more effective penicillin formulations and dosing regimens[3].
• Continuous Manufacturing Processes: The adoption of continuous manufacturing processes offers advantages such as advanced performance, reduced production costs, and better quality control, enhancing the efficiency of penicillin production[3].
• Digital Health Technology: The integration of digital health technology, including telemedicine platforms, streamlines patient care and medication management, improving adherence to penicillin treatment regimens and outcomes[3].

Challenges and Barriers

Despite the growth potential, the penicillin market faces several challenges:

• Antibiotic Resistance: Increasing consciousness of the risks associated with antibiotic overuse, including the development of antibiotic-resistant bacteria, may lead to stricter prescribing guidelines and reduced demand for penicillin[3].
• Regulatory Requirements: Stringent regulatory requirements for the approval of new drugs can result in delays and increased costs, posing a barrier to market access for pharmaceutical companies[3].
• Raw Material Dependence: Dependence on specific raw materials for penicillin production, coupled with supply chain disruptions and shortages, can constrain market growth and impact drug availability[3].

Financial Considerations

The financial trajectory of Penicillin V potassium is influenced by several factors:

• Pricing: The price of Penicillin V potassium can vary significantly depending on the region and supplier. For example, the unit rate for Penicillin V potassium in India is around USD 39.3 per kg, while in Vietnam it is approximately USD 25.6 per kg[1].
• Cost-Effectiveness: Oral administration of Penicillin V potassium is cost-effective and preferred by patients, which contributes to its market growth[3].
• Market Competition: The presence of generic and branded penicillin products creates price pressures, particularly in price-sensitive markets. Acquisitions of complementary product lines or technology can help pharmaceutical companies diversify their portfolios and seize new growth opportunities[3].

Key Applications and Indications

Penicillin V potassium is indicated for the treatment of mild to moderately severe infections caused by penicillin G-sensitive microorganisms. These include:

• Streptococcal infections (e.g., upper respiratory tract infections, scarlet fever, erysipelas)
• Pneumococcal infections (e.g., respiratory tract infections, otitis media)
• Staphylococcal infections (e.g., mild skin and soft tissue infections)[2][5].

Dosage and Administration

The dosage of Penicillin V potassium is determined based on the sensitivity of the causative microorganisms and the severity of the infection. It is typically administered orally, with dosages ranging from 125 mg to 500 mg every 6 to 8 hours, depending on the type of infection[2].

Side Effects and Safety

While Penicillin V potassium is generally safe, it can cause side effects such as diarrhea, nausea, vomiting, and abdominal pain. Serious side effects include rash, hives, itching, and difficulty swallowing or breathing. It is crucial to follow the prescribed dosage and complete the full treatment course to avoid the development of antibiotic-resistant bacteria[5].

Key Takeaways

• The global penicillin market, including Penicillin V potassium, is expected to grow to USD 13.4 billion by 2033.
• Natural penicillin dominates the market due to its historical prominence and safety.
• Oral administration is the preferred route due to convenience and cost-effectiveness.
• North America leads the market with a significant revenue share.
• The market faces challenges such as antibiotic resistance and stringent regulatory requirements.
• Penicillin V potassium is indicated for various bacterial infections and has specific dosage and administration guidelines.

FAQs

Q: What is the projected market size of the penicillin drug market by 2033? A: The global penicillin drug market is expected to reach over USD 13.4 billion by 2033[3].

Q: Why does natural penicillin dominate the market? A: Natural penicillin dominates due to its historical prominence, safety, and compliance with regulations, as well as its perceived natural origin and efficacy against antibiotic resistance[3].

Q: What are the common indications for Penicillin V potassium? A: Penicillin V potassium is indicated for the treatment of streptococcal, pneumococcal, and staphylococcal infections, among others[2][5].

Q: What are the potential side effects of Penicillin V potassium? A: Common side effects include diarrhea, nausea, and vomiting, while serious side effects can include rash, hives, and difficulty swallowing or breathing[5].

Q: How does the integration of digital health technology impact the penicillin market? A: Digital health technology streamlines patient care and medication management, improving adherence to penicillin treatment regimens and outcomes[3].

Cited Sources:

1. PharmaCompass.com - Penicillin V Potassium | Price | per kg | USD
2. Drugs.com - Penicillin V Potassium: Package Insert / Prescribing Info
3. GlobeNewswire - Penicillin Drug Market Is Expected To Reach a Revenue Of USD 13.4 Bn By 2033
4. ECHEMI - Penicillin V potassium Price and Market Analysis
5. MedlinePlus - Penicillin V Potassium: MedlinePlus Drug Information