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Last Updated: March 31, 2025

FULVICIN P/G Drug Patent Profile


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Which patents cover Fulvicin P/g, and when can generic versions of Fulvicin P/g launch?

Fulvicin P/g is a drug marketed by Chartwell Rx and is included in one NDA.

The generic ingredient in FULVICIN P/G is griseofulvin, ultramicrosize. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.

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Drug patent expirations by year for FULVICIN P/G
Pharmacology for FULVICIN P/G

US Patents and Regulatory Information for FULVICIN P/G

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Chartwell Rx FULVICIN P/G griseofulvin, ultramicrosize TABLET;ORAL 061996-001 Approved Prior to Jan 1, 1982 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Chartwell Rx FULVICIN P/G griseofulvin, ultramicrosize TABLET;ORAL 061996-002 Approved Prior to Jan 1, 1982 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Chartwell Rx FULVICIN P/G 165 griseofulvin, ultramicrosize TABLET;ORAL 061996-003 Apr 6, 1982 RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Chartwell Rx FULVICIN P/G 330 griseofulvin, ultramicrosize TABLET;ORAL 061996-004 Apr 6, 1982 RX No No ⤷  Try for Free ⤷  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 4 of 4 entries

Market Dynamics and Financial Trajectory for the Drug: FULVICIN P/G (Griseofulvin)

Introduction

Griseofulvin, marketed under various brand names including FULVICIN P/G, is an antifungal medication used to treat fungal infections of the skin, hair, and nails. To understand the market dynamics and financial trajectory of this drug, we need to delve into several key areas, including its usage, market trends, and economic factors influencing its development and pricing.

Usage and Clinical Applications

Griseofulvin is primarily used to treat tinea infections such as tinea corporis, tinea capitis, tinea pedis, and tinea unguium. The dosage and duration of treatment vary depending on the type of infection and the formulation of the drug (microsize or ultramicrosize)[2].

Market Trends in Antifungal Medications

The market for antifungal medications is influenced by several trends:

Increasing Resistance to Antifungal Drugs

The rise in antifungal resistance has driven the need for new and effective treatments. However, griseofulvin, being an older drug, faces challenges in this regard, as its efficacy may be compromised by emerging resistant strains.

Shift to Precision Medicines

The pharmaceutical industry is increasingly focusing on precision medicines, which target specific patient populations. While griseofulvin is not a precision medicine, the overall trend towards more targeted therapies can impact the market dynamics for traditional antifungals[3].

Economic Factors Influencing Drug Development and Pricing

Research and Development Costs

The development of new antifungal drugs is costly and time-consuming. Griseofulvin, having been developed decades ago, does not incur these high R&D costs. However, any modifications or new formulations would need to consider these expenses.

Pricing Strategies

Drugs targeting small patient populations, such as some newer antifungals, can command high prices due to their value to those patients. Griseofulvin, with its broader application, is generally priced lower. The pricing strategy for griseofulvin is influenced by its generic availability and competition from other antifungal medications[3].

Generic Competition and Market Impact

Griseofulvin is available in generic form, which significantly impacts its market dynamics:

Generic Entry and Price Competition

Generic versions of griseofulvin reduce the market share and pricing power of the branded version. This competition drives down prices, making the drug more affordable but also reducing the revenue potential for the original manufacturer[3].

Lack of Generic Competition in Niche Markets

While griseofulvin faces generic competition, newer antifungals targeting smaller patient populations may not. This lack of competition in niche markets can lead to higher prices for those drugs, but it does not directly affect the market for griseofulvin.

Financial Trajectory

Revenue and Sales

Given its generic status, the revenue from griseofulvin is likely to be stable but not growing significantly. The drug's sales are influenced by its widespread use and the availability of cheaper generic alternatives.

Cost Structure

The cost structure for griseofulvin includes manufacturing costs, which are generally lower due to its long-standing presence in the market. However, any new formulations or improvements would add to these costs.

Profitability

The profitability of griseofulvin is affected by its low pricing due to generic competition. While it remains a profitable drug, its margins are likely lower compared to newer, patented antifungals.

Regulatory and Safety Considerations

Safety Profile

Griseofulvin has a well-documented safety profile, but it also has potential side effects and interactions. Regulatory bodies closely monitor its use, especially in light of some studies suggesting potential carcinogenic effects, although these findings are not conclusive[2].

Regulatory Environment

Changes in regulatory environments can impact the drug's market. For example, stricter safety standards or new guidelines on antifungal use could affect its prescription rates.

Market Outlook

Competitive Landscape

The competitive landscape for antifungal medications is diverse, with both older drugs like griseofulvin and newer, more targeted therapies. Griseofulvin competes with other generic and branded antifungals, each with their own strengths and weaknesses.

Future Prospects

The future prospects for griseofulvin are stable but not highly growth-oriented. As new antifungals are developed, they may capture market share from older drugs. However, griseofulvin's established position and low cost ensure it remains a viable treatment option.

Key Takeaways

  • Usage and Applications: Griseofulvin is used to treat various fungal infections, with dosages varying by infection type and drug formulation.
  • Market Trends: The shift towards precision medicines and increasing antifungal resistance are key trends affecting the market.
  • Economic Factors: High R&D costs, generic competition, and pricing strategies significantly influence the financial trajectory of griseofulvin.
  • Financial Trajectory: Revenue is stable but not growing significantly, with lower profitability due to generic competition.
  • Regulatory and Safety Considerations: The drug's safety profile and regulatory environment are crucial factors in its market dynamics.

FAQs

Q: What is the primary use of griseofulvin? A: Griseofulvin is primarily used to treat fungal infections of the skin, hair, and nails.

Q: How does generic competition affect griseofulvin's market? A: Generic competition reduces the market share and pricing power of branded griseofulvin, making the drug more affordable but also reducing revenue potential.

Q: What are the economic implications of precision medicines on the antifungal market? A: Precision medicines can lead to higher prices for targeted therapies, but this does not directly impact the market for broader-spectrum drugs like griseofulvin.

Q: What are the potential side effects and safety concerns associated with griseofulvin? A: Griseofulvin has a well-documented safety profile but can have side effects and potential interactions. Some studies suggest possible carcinogenic effects, although these findings are not conclusive.

Q: What is the outlook for griseofulvin in the future antifungal market? A: The outlook is stable but not highly growth-oriented, as new antifungals may capture market share from older drugs like griseofulvin.

Sources

  1. IARC Publications - Griseofulvin: Exposure Data.
  2. IARC Publications - Griseofulvin: Studies of Cancer in Humans.
  3. NBER - The Economics of Drug Development: Pricing and Innovation in a Changing Market.

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