You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 5, 2025

MICONAZOLE NITRATE COMBINATION PACK Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Miconazole Nitrate Combination Pack patents expire, and what generic alternatives are available?

Miconazole Nitrate Combination Pack is a drug marketed by L Perrigo Co and is included in one NDA.

The generic ingredient in MICONAZOLE NITRATE COMBINATION PACK is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Miconazole Nitrate Combination Pack

A generic version of MICONAZOLE NITRATE COMBINATION PACK was approved as miconazole nitrate by ACTAVIS PHARMA on November 19th, 1993.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for MICONAZOLE NITRATE COMBINATION PACK?
  • What are the global sales for MICONAZOLE NITRATE COMBINATION PACK?
  • What is Average Wholesale Price for MICONAZOLE NITRATE COMBINATION PACK?
Drug patent expirations by year for MICONAZOLE NITRATE COMBINATION PACK
Recent Clinical Trials for MICONAZOLE NITRATE COMBINATION PACK

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

SponsorPhase
Aesculape CRO Belgium BVPhase 2
Population CouncilPhase 1
Galeno Desenvolvimento de Pesquisas ClínicasPhase 2

See all MICONAZOLE NITRATE COMBINATION PACK clinical trials

US Patents and Regulatory Information for MICONAZOLE NITRATE COMBINATION PACK

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
L Perrigo Co MICONAZOLE NITRATE COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 075329-001 Apr 20, 1999 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

MICONAZOLE NITRATE COMBINATION PACK Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Miconazole Nitrate Combination Packs

Introduction to Miconazole Nitrate

Miconazole nitrate is an antifungal medication commonly used to treat various fungal infections, including vaginal yeast infections. It is available in several forms, including creams, suppositories, and combination packs that include both internal and external treatments.

Market Overview

The market for drug-device combination products, which includes miconazole nitrate combination packs, is experiencing significant growth. Here are some key dynamics and financial insights:

Market Size and Growth

The global drug-device combination products market was valued at USD 110.2 billion in 2022 and is projected to grow at a CAGR of 7.1% from 2023 to 2029, reaching nearly USD 178.12 billion by 2029[3].

Segment Analysis

Within the drug-device combination products market, transdermal patches dominate, but combination kits like those for miconazole nitrate also play a crucial role. These kits offer a streamlined approach to healthcare delivery, emphasizing efficient drug-device integration. The demand for such products is driven by the need for self-administration, particularly in long-term treatments for chronic diseases[3].

Regional Insights

North America is the leading region in the drug-device combination products market, driven by significant new product development efforts and the increasing burden of chronic diseases. The Asia Pacific region is also expected to experience substantial growth due to increased healthcare spending and rising awareness among physicians about the advantages of these products[3].

Product Specifics: Miconazole Nitrate Combination Packs

Types of Combination Packs

Miconazole nitrate combination packs come in various forms, such as:

  • 3-Day Treatment Combination Packs: These include vaginal suppositories or creams along with external itch relief creams. For example, the MONISTAT® 3-Day Treatment Combination Pack Suppositories and the Rite Aid Miconazole 3 Day Treatment Combination Pack[1][5].
  • 7-Day Treatment Combination Packs: These typically include a tube of miconazole cream and multiple applicators, along with external itch relief cream. The MONISTAT® 7-Day Treatment Combination Pack is a notable example[2].

Efficacy and Clinical Trials

Clinical trials have shown that miconazole nitrate combination packs are highly effective in treating vulvovaginal candidiasis. For instance, a three-day regimen using 400 mg miconazole nitrate vaginal ovules has yielded mycological and clinical cure rates of approximately 80-90%[4].

Safety and Regulatory Considerations

The development and regulatory approval of drug-device combination products, including miconazole nitrate packs, involve complex procedures. Manufacturers must ensure the safety and efficacy of these products, addressing potential issues such as adverse incidents or device malfunctions. Regulatory hurdles and safety concerns can delay product development and market entry[3].

Technological Innovation

Technological innovation is a key driver in the drug-device combination products market. Advanced formulations, delivery methods, and dosage forms such as peptides, liposomes, and transdermal systems are being introduced. These innovations improve treatment outcomes and patient adherence, contributing to the market's growth[3].

Financial Implications

The growing demand for drug-device combination products, including miconazole nitrate packs, is driven by their ability to improve treatment adherence and outcomes. This demand translates into significant financial opportunities for manufacturers. Here are some financial implications:

  • Market Growth: The projected growth of the drug-device combination products market to USD 178.12 billion by 2029 indicates a lucrative financial trajectory for products like miconazole nitrate combination packs[3].
  • Investments in R&D: Companies are investing heavily in research and development to introduce new and sophisticated medical solutions, which includes combination packs. This investment is expected to yield high returns as these products gain market acceptance[3].

Consumer and Healthcare Provider Perspectives

From a consumer perspective, miconazole nitrate combination packs offer convenience and comprehensive treatment for yeast infections, including both internal and external relief. For healthcare providers, these products simplify treatment regimens and improve patient compliance.

Competitive Landscape

The market for miconazole nitrate combination packs is competitive, with brands like MONISTAT® and Rite Aid offering various treatment options. The competitive landscape is driven by innovation, efficacy, and consumer preference.

Intellectual Property and Legal Considerations

Protecting intellectual property in the drug-device combination products market can be challenging due to the convergence of technologies from both the pharmaceutical and medical device sectors. Companies may face legal battles over patents, which can hinder innovation and market access[3].

Key Takeaways

  • Growing Market: The global drug-device combination products market, including miconazole nitrate packs, is expected to grow significantly.
  • Efficacy and Convenience: Miconazole nitrate combination packs offer high efficacy and convenience for treating yeast infections.
  • Regulatory and Safety Considerations: Manufacturers must navigate complex regulatory procedures and ensure product safety.
  • Technological Innovation: Advanced formulations and delivery methods drive market growth.
  • Financial Opportunities: The market presents lucrative financial opportunities for manufacturers.

FAQs

What is the projected market size for drug-device combination products by 2029?

The market size for drug-device combination products is projected to reach nearly USD 178.12 billion by 2029[3].

What are the key components of miconazole nitrate combination packs?

Miconazole nitrate combination packs typically include vaginal suppositories or creams along with external itch relief creams[1][5].

How effective are miconazole nitrate combination packs in treating yeast infections?

Clinical trials have shown that miconazole nitrate combination packs can achieve mycological and clinical cure rates of approximately 80-90% for vulvovaginal candidiasis[4].

What are the regulatory challenges for drug-device combination products?

The development and regulatory approval of these products involve managing complex procedures from both pharmaceutical and medical device industries, which can delay market entry[3].

Why is technological innovation important in the drug-device combination products market?

Technological innovation introduces advanced formulations, delivery methods, and dosage forms, improving treatment outcomes and patient adherence, thus driving market growth[3].

What is the significance of the North America region in the drug-device combination products market?

North America dominates the market due to significant new product development efforts and the increasing burden of chronic diseases in the region[3].

Sources

  1. Rite Aid Miconazole 3 Day Treatment, Combination Pack. Rite Aid.
  2. MONISTAT® 7-Day Yeast Infection Treatment Combination Pack (Cream). Monistat.
  3. Drug Device Combination Products Market: Global Industry. Maximize Market Research.
  4. *MONISTAT 1 Combination Pack**. Insight Pharmaceuticals LLC.
  5. MONISTAT® 3-Day Treatment Combination Pack Suppositories. Monistat.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.