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Last Updated: December 22, 2024

MONODOX Drug Patent Profile


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When do Monodox patents expire, and what generic alternatives are available?

Monodox is a drug marketed by Chartwell Rx and is included in one NDA.

The generic ingredient in MONODOX is doxycycline. There are twenty-eight drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the doxycycline profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Monodox

A generic version of MONODOX was approved as doxycycline by SUN PHARM INDS LTD on November 22nd, 2000.

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Summary for MONODOX
Drug patent expirations by year for MONODOX
Drug Prices for MONODOX

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Drug Sales Revenue Trends for MONODOX

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Recent Clinical Trials for MONODOX

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

SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 3
University of WashingtonPhase 3
Par Pharmaceutical, Inc.Phase 1

See all MONODOX clinical trials

Pharmacology for MONODOX

US Patents and Regulatory Information for MONODOX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx MONODOX doxycycline CAPSULE;ORAL 050641-002 Feb 10, 1992 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx MONODOX doxycycline CAPSULE;ORAL 050641-004 Feb 17, 2022 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx MONODOX doxycycline CAPSULE;ORAL 050641-003 Oct 18, 2006 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx MONODOX doxycycline CAPSULE;ORAL 050641-001 Dec 29, 1989 AB RX Yes 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

EU/EMA Drug Approvals for MONODOX

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pfizer Limited Doxirobe Doxycycline EMEA/V/C/000044
Treatment of periodontal disease in dogs.Periodontal pocket probing depths >=4 mm are evidence of disease that may be responsive to treatment with the Doxirobe Gel. Use of this product as directed should result in attachment level gains, periodontal pocket depth reductions, local antimicrobial effect and improved gingival health. Noticeable improvements in these parameters should be evident within 2-4 weeks following treatment. The response in individual dogs is dependent on the severity of the condition and rigor of adjunctive therapy.
Withdrawn no no no 1999-09-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

MONODOX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Monodox

Introduction

Monodox, a brand name for the antibiotic doxycycline hyclate, is a widely used medication for various bacterial infections. Understanding the market dynamics and financial trajectory of Monodox is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth

The oral doxycycline hyclate market, which includes Monodox, has been experiencing significant growth. As of 2022, the market size was valued at USD 4.2 billion and is projected to grow to USD 9.2 billion by 2032, with a compound annual growth rate (CAGR) that reflects increasing demand for antibiotics[1].

Product Types and Applications

Monodox is available in various forms, including tablets, capsules, and oral suspensions. These formulations cater to different patient needs and preferences. The primary applications of Monodox include treating intestinal infections, respiratory tract infections, urinary tract infections, and other bacterial infections[1].

Distribution Channels

The distribution of Monodox occurs through several channels, including hospital pharmacies, retail pharmacies, and online pharmacies. Each channel plays a significant role in making the drug accessible to a wide range of patients. Hospital pharmacies and retail pharmacies remain the dominant distribution channels, while online pharmacies are gaining traction due to convenience and cost-effectiveness[1].

Regional Market Analysis

The market for Monodox is spread across various regions, including North America, Europe, Asia-Pacific, and the rest of the world. North America and Europe are significant markets due to their well-established healthcare systems and high demand for antibiotics. The Asia-Pacific region is also growing rapidly, driven by increasing healthcare expenditure and a large patient population[1].

Pricing and Revenue Strategies

Pharmaceutical companies often employ various pricing and revenue strategies to maximize profits. For instance, Valeant Pharmaceuticals, a company known for its aggressive pricing strategies, increased the prices of several drugs, including those used to treat rare conditions, to boost revenue. However, such strategies can be controversial and may face regulatory scrutiny[2].

Impact of Regulatory Changes

Regulatory changes can significantly impact the financial trajectory of drugs like Monodox. The Inflation Reduction Act of 2022, for example, includes provisions aimed at reducing prescription drug spending for Medicare beneficiaries. This act caps insulin cost-sharing, requires rebates from pharmaceutical manufacturers if prices rise faster than inflation, and allows the federal government to negotiate prices for certain high-spend drugs. These changes are expected to moderate the growth in prescription drug spending and could affect the revenue of drugs like Monodox[3].

Competition from Generic and Authorized Generic Drugs

The introduction of generic and authorized generic drugs can significantly impact the market dynamics of branded drugs like Monodox. Authorized generics, which are generic versions of a brand-name drug sold by the brand-name company itself, can reduce prices and revenues for both the brand-name and independent generic manufacturers. During the 180-day exclusivity period, authorized generics can lower retail generic prices by 4-8% and wholesale prices by 7-14%, benefiting consumers but reducing revenues for competing generic firms[4].

Patient Access and Affordability

Patient access and affordability are critical factors in the market dynamics of Monodox. Medicare coverage and prescription drug plans play a significant role in making the drug affordable for patients. Tools like GoodRx help patients understand Medicare coverage and co-pay details, facilitating better access to necessary medications[5].

Ethical and Compliance Considerations

Pharmaceutical companies must maintain high ethical standards and comply with regulatory requirements. The case of Valeant Pharmaceuticals highlights the risks associated with unethical practices, such as deceptive pricing strategies and secret pharmacy networks. Companies must prioritize patient needs and maintain transparency in their business practices to build trust and ensure long-term sustainability[2].

Market Trends and Forecast

The market for Monodox is expected to grow moderately over the next decade, driven by increasing demand for antibiotics and expanding healthcare access. However, this growth will be influenced by regulatory changes, competition from generics, and evolving patient needs. The Inflation Reduction Act and other regulatory measures are likely to moderate spending on prescription drugs, including Monodox[3].

Financial Performance

The financial performance of Monodox is closely tied to the overall market trends and regulatory environment. As the market grows, companies manufacturing Monodox can expect increased revenues, but they must also navigate the challenges posed by generic competition and regulatory changes. Effective pricing strategies, strong distribution networks, and a focus on patient needs will be crucial for maintaining financial health[1].

Key Takeaways

  • The oral doxycycline hyclate market, including Monodox, is projected to grow significantly by 2032.
  • Distribution channels such as hospital pharmacies, retail pharmacies, and online pharmacies are vital for drug accessibility.
  • Regulatory changes, like the Inflation Reduction Act, can impact revenue and pricing strategies.
  • Competition from generic and authorized generic drugs affects market dynamics and revenue.
  • Patient access and affordability are critical, influenced by Medicare coverage and prescription drug plans.
  • Ethical and compliance considerations are essential for long-term sustainability.

FAQs

What is the projected market size for oral doxycycline hyclate by 2032?

The oral doxycycline hyclate market is projected to grow to USD 9.2 billion by 2032[1].

How do regulatory changes impact the market for Monodox?

Regulatory changes, such as the Inflation Reduction Act, can moderate prescription drug spending and affect the revenue of drugs like Monodox by capping prices and requiring rebates from manufacturers[3].

What is the impact of authorized generic drugs on the market for Monodox?

Authorized generic drugs can lower prices and reduce revenues for both brand-name and independent generic manufacturers, benefiting consumers but affecting the financial performance of these companies[4].

How does Medicare coverage affect the affordability of Monodox?

Medicare coverage and prescription drug plans help make Monodox more affordable for patients by reducing out-of-pocket costs and providing clear co-pay details[5].

What are the key distribution channels for Monodox?

The key distribution channels for Monodox include hospital pharmacies, retail pharmacies, and online pharmacies[1].

More… ↓

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