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Last Updated: December 22, 2024

DOXYCHEL Drug Patent Profile


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

Doxychel is a drug marketed by Rachelle and is included in two NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Doxychel

A generic version of DOXYCHEL was approved as doxycycline hyclate by EPIC PHARMA LLC on November 8th, 1982.

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Summary for DOXYCHEL
Drug patent expirations by year for DOXYCHEL
Recent Clinical Trials for DOXYCHEL

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

SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 3
University of WashingtonPhase 3

See all DOXYCHEL clinical trials

US Patents and Regulatory Information for DOXYCHEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rachelle DOXYCHEL doxycycline FOR SUSPENSION;ORAL 061720-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rachelle DOXYCHEL HYCLATE doxycycline hyclate INJECTABLE;INJECTION 061953-001 Approved Prior to Jan 1, 1982 DISCN 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

EU/EMA Drug Approvals for DOXYCHEL

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

DOXYCHEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Doxycycline Hydrochloride (DOXYCHEL)

Introduction

Doxycycline hydrochloride, a synthetic tetracycline derivative, is a widely used antibiotic with a broad spectrum of antimicrobial activity. This article delves into the current market dynamics, financial trajectory, and future outlook for doxycycline hydrochloride, highlighting key drivers, challenges, and trends.

Market Overview

The market for doxycycline hydrochloride is characterized by robust demand from the healthcare and pharmaceutical sectors. This demand is driven by the antibiotic's effectiveness in treating various bacterial infections, including respiratory tract infections, sexually transmitted infections, and tick-borne illnesses[4].

Demand Factors

Increasing Incidence of Infectious Diseases

The global burden of infectious diseases is a significant driver of the demand for doxycycline hydrochloride. The rising incidence of bacterial infections has led to an increased need for effective antibiotic treatments, thereby boosting the market for this drug[4].

Generic Medications

The availability of generic versions of doxycycline hydrochloride has made the antibiotic more affordable and accessible to patients. This has contributed to the market growth, as generic medications often reduce the financial barrier to treatment[4].

New Market Entrants

Recent entries into the market, such as Lupin Limited's generic version of Oracea® (Doxycycline Capsules, 40 mg), have further amplified the demand. This move, approved by the U.S. FDA, targets the treatment of inflammatory lesions associated with rosacea and generates significant revenue, estimated at $128 million annually in the US alone[1].

Supply Chain and Pricing Dynamics

Limited Supply and Logistical Challenges

The prices of doxycycline hydrochloride are expected to rise due to limited supply and logistical challenges. Global shipping delays, particularly the closure of the Port of Baltimore and disruptions in the Red Sea, have created bottlenecks in the supply chain. These issues increase the costs associated with redirecting shipments, which are likely to be passed on to consumers[1].

Geopolitical Tensions

Geopolitical tensions, such as the conflict between Iran and Israel, add complexity to the supply chain. These tensions can lead to increased crude oil prices, higher transportation costs, and potential interruptions in shipping and air freight services, all of which can drive up the prices of doxycycline hydrochloride[1].

Financial Trajectory

Current Pricing Trends

The prices of doxycycline hydrochloride are poised to continue their upward trajectory in the coming months. This trend is supported by consistent demand from downstream industries and the limited supply levels. Any potential easing of inflation in the US could also stimulate demand, further influencing pricing dynamics[1].

Revenue Projections

The global oral doxycycline hyclate market, which includes doxycycline hydrochloride, is projected to grow with a compound annual growth rate (CAGR) of 5.8% by 2030. This growth is driven by the increasing incidence of infectious diseases and the widespread use of doxycycline hyclate as an effective antibiotic[4].

Market Drivers

Research and Development

Ongoing research and development efforts to enhance the efficacy and safety of doxycycline hyclate formulations are opening new avenues for market growth. These efforts aim to address concerns such as antimicrobial resistance and to develop innovative treatment regimens[4].

Widespread Adoption

The versatility of doxycycline hyclate, which can be used to treat a wide range of infections, is expanding its adoption in clinical practice. This broad applicability is a significant driver of the market, as it makes the antibiotic a preferred choice for various medical conditions[4].

Challenges and Restraints

Antibiotic Resistance

The emergence of antibiotic-resistant strains of bacteria is a significant concern that could limit the long-term effectiveness of doxycycline hyclate. This issue necessitates continuous research and development to maintain the drug's efficacy[4].

Regulatory Hurdles

Stringent regulatory requirements for the approval of antibiotic medications pose challenges for manufacturers. These regulations can delay the market entry of new formulations and impact the overall market growth[4].

Competition

The market for doxycycline hyclate is highly competitive, with multiple manufacturers producing generic versions. This competition leads to pricing pressures, which can affect the profitability of market participants[4].

Regional Analysis

North America

North America, particularly the United States, holds a substantial share of the market due to the prevalence of infectious diseases and a robust healthcare infrastructure. The US market is expected to continue driving demand for doxycycline hydrochloride[4].

Europe and Asia-Pacific

Europe, with countries like Germany and the UK, and the Asia-Pacific region, with increasing healthcare investments and a growing incidence of bacterial infections, are also significant contributors to the market revenue[4].

Competitive Landscape

The oral doxycycline hyclate market features intense competition among key players, including generic pharmaceutical companies and established drug manufacturers. Companies such as Pfizer Inc., Teva Pharmaceuticals, and Mylan N.V. are focused on product innovation, quality assurance, and strategic collaborations to maintain their competitive edge[4].

Future Outlook

The global oral doxycycline hyclate market is poised for substantial growth in the coming years. The increasing prevalence of infectious diseases, the demand for effective antibiotics, and ongoing research efforts to address antibiotic resistance are expected to drive market expansion. Despite challenges such as regulatory hurdles and competition, the market’s prospects remain promising, making it an attractive sector for investment and growth[4].

Key Takeaways

  • Robust Demand: The market is driven by consistent demand from healthcare and pharmaceutical sectors.
  • Supply Chain Challenges: Limited supply and logistical issues are expected to drive up prices.
  • Geopolitical Impact: Tensions and conflicts can affect supply chains and pricing.
  • Financial Growth: The market is projected to grow with a CAGR of 5.8% by 2030.
  • Research and Development: Ongoing efforts to enhance efficacy and address antimicrobial resistance are crucial.
  • Regional Variations: North America, Europe, and Asia-Pacific are key regions driving market growth.

FAQs

Q: What are the primary drivers of the demand for doxycycline hydrochloride?

The primary drivers include the increasing incidence of infectious diseases and the widespread use of doxycycline hyclate as an effective antibiotic.

Q: How do logistical challenges affect the market for doxycycline hydrochloride?

Logistical challenges such as global shipping delays and the closure of major ports can disrupt supply chains, leading to increased costs and higher prices.

Q: What is the projected growth rate for the oral doxycycline hyclate market?

The market is projected to grow with a compound annual growth rate (CAGR) of 5.8% by 2030.

Q: Which regions are significant contributors to the market revenue for doxycycline hydrochloride?

North America, particularly the United States, Europe, and the Asia-Pacific region are significant contributors to the market revenue.

Q: What are the major challenges facing the market for doxycycline hydrochloride?

Major challenges include antibiotic resistance, stringent regulatory requirements, and intense competition among manufacturers.

Sources

  1. ChemAnalyst: Increased Demand and Limited Supply to Push Up Doxycycline Hydrochloride Prices in the US[1].
  2. PharmaCompass: Doxychel - Uses, DMF, Dossier, Manufacturer, Supplier, Licensing[2].
  3. National Bureau of Economic Research: The Economics of Drug Development: Pricing and Innovation in a Changing Market[3].
  4. MarkWide Research: Oral Doxycycline Hyclate Market Poised for Growth with a Projected CAGR of 5.8% by 2030[4].

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