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Last Updated: April 1, 2025

Doxycycline calcium - Generic Drug Details


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What are the generic drug sources for doxycycline calcium and what is the scope of freedom to operate?

Doxycycline calcium is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for doxycycline calcium
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 6
Clinical Trials: 5
Patent Applications: 382
DailyMed Link:doxycycline calcium at DailyMed
Recent Clinical Trials for doxycycline calcium

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

SponsorPhase
Lund University HospitalPhase 4
Aksaray UniversityPhase 4
Edward Lain, MDPhase 4

See all doxycycline calcium clinical trials

US Patents and Regulatory Information for doxycycline calcium

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Pfizer VIBRAMYCIN doxycycline calcium SUSPENSION;ORAL 050480-001 Approved Prior to Jan 1, 1982 DISCN Yes 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 1 of 1 entries

Market Dynamics and Financial Trajectory for Doxycycline Hyclate

Introduction

Doxycycline hyclate, a broad-spectrum antibiotic, has been a cornerstone in the treatment of various bacterial infections, acne, and malaria. The market for this drug is influenced by several factors, including its efficacy, demand for effective antibiotics, and advancements in healthcare infrastructure.

Market Size and Growth

The doxycycline hyclate market was valued at USD 1.2 billion in 2023 and is projected to reach USD 1.8 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.5% from 2024 to 2031[1].

Key Drivers of Market Growth

Several factors are driving the growth of the doxycycline hyclate market:

Increasing Incidence of Bacterial Infections

The rise in cases of bacterial infections such as urinary tract infections, pneumonia, and respiratory diseases is a significant driver. The surge in hospital-acquired infections and the need for home-based treatment also contribute to the market's expansion[3].

Effectiveness in Treating Various Conditions

Doxycycline hyclate is effective in treating acne, malaria, and other bacterial diseases, making it a preferred choice among healthcare professionals. Its broad-spectrum efficacy against a variety of bacterial infections, including respiratory and urinary tract infections, further boosts its demand[1].

Advancements in Pharmaceutical Formulations

Improvements in pharmaceutical formulations and increased accessibility in both developed and developing countries are enhancing the market prospects. The launch of novel drugs and ongoing research and development activities to improve the quality of doxycycline hyclate also play a crucial role[1][3].

Government Initiatives and Regulatory Approvals

Government initiatives for regulatory approvals and awareness campaigns regarding bacterial infection treatment are expected to offer lucrative opportunities for market expansion. These initiatives help in streamlining the market and ensuring the drug's availability and accessibility[3].

Market Segmentation

The doxycycline hyclate market is segmented based on several criteria:

By Application

  • Antibiotics
  • Acne Treatment
  • Malaria Treatment
  • Veterinary Medicine

These segments highlight the diverse uses of doxycycline hyclate, each contributing to the overall market growth[1].

By Product

  • Tablets
  • Capsules
  • Powder
  • Injection Formulations

The variety in product forms caters to different patient needs and preferences, enhancing market penetration[1].

By Geography

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle East and Africa

Geographical segmentation helps in understanding regional market dynamics and identifying potential growth areas[1].

Market Trends

New Product Launches

The market is expected to flourish with the launch of new and innovative formulations of doxycycline hyclate. These launches are driven by R&D activities aimed at improving the drug's efficacy and reducing adverse effects[3].

Surge in Demand for Minimally Invasive Treatments

There is an increasing demand for minimally invasive treatment procedures, which includes the use of oral antibiotics like doxycycline hyclate. This trend is driven by patient preference for less invasive and more convenient treatment options[3].

Impact of COVID-19

The COVID-19 pandemic has presented both challenges and opportunities for the pharmaceutical industry. While it has disrupted supply chains, it has also highlighted the need for effective antibiotics and other medications, thereby boosting demand for drugs like doxycycline hyclate[3].

Challenges and Restraints

Adverse Effects

Despite its efficacy, doxycycline hyclate is associated with several adverse effects, including severe skin reactions, intracranial hypertension, and Clostridioides difficile-associated diarrhea (CDAD). These side effects can hinder market growth[2].

Presence of Alternative Treatments

The availability of alternative treatments for bacterial infections can also act as a restraint. Patients and healthcare providers may opt for other antibiotics or treatment modalities, affecting the demand for doxycycline hyclate[3].

Competitive Scenario

The doxycycline hyclate market is competitive, with several key players involved:

  • Pfizer
  • Novartis
  • GlaxoSmithKline
  • Teva Pharmaceuticals
  • Mylan
  • Cipla
  • Lupin Pharmaceuticals
  • Sun Pharmaceutical
  • Sandoz
  • Aurobindo Pharma

These companies are engaged in continuous R&D, new product launches, and strategic partnerships to maintain their market share and drive growth[1].

Financial Outlook

Revenue Projections

The market is expected to grow significantly, with revenue projected to reach USD 1.8 billion by 2031. This growth is driven by increasing demand, advancements in formulations, and expanding healthcare infrastructure[1].

Investment Opportunities

The growing demand for effective antibiotics and the need for innovative formulations present lucrative investment opportunities. Companies investing in R&D and expanding their product portfolios are likely to benefit from the market's growth[3].

Key Takeaways

  • The doxycycline hyclate market is driven by its broad-spectrum efficacy, increasing incidence of bacterial infections, and advancements in pharmaceutical formulations.
  • The market is segmented by application, product form, and geography, each segment contributing to the overall growth.
  • New product launches, surge in demand for minimally invasive treatments, and government initiatives are key trends.
  • Adverse effects and the presence of alternative treatments are significant restraints.
  • The market is competitive, with major players focusing on R&D and strategic partnerships.

Frequently Asked Questions (FAQs)

Q: What is the projected market size of doxycycline hyclate by 2031? A: The doxycycline hyclate market is expected to reach USD 1.8 billion by 2031[1].

Q: What are the key drivers of the doxycycline hyclate market? A: Key drivers include the increasing incidence of bacterial infections, effectiveness in treating various conditions, advancements in pharmaceutical formulations, and government initiatives[1][3].

Q: What are the common adverse effects associated with doxycycline hyclate? A: Common adverse effects include severe skin reactions, intracranial hypertension, and Clostridioides difficile-associated diarrhea (CDAD)[2].

Q: Which companies are major players in the doxycycline hyclate market? A: Major players include Pfizer, Novartis, GlaxoSmithKline, Teva Pharmaceuticals, and others[1].

Q: How has the COVID-19 pandemic impacted the doxycycline hyclate market? A: The pandemic has highlighted the need for effective antibiotics, thereby boosting demand for doxycycline hyclate, despite some disruptions in supply chains[3].

Cited Sources:

  1. Market Research Intellect - Doxycycline Hyclate Market Size, Share & Growth [2024-2031][1]
  2. FDA - Vibramycin Calcium (doxycycline calcium oral suspension, USP) Label[2]
  3. Allied Market Research - Oral Doxycycline Hyclate Market Size | Industry Growth By, 2030[3]
  4. Market Research Future - Oral Doxycycline Hyclate Market Size, Trends, Report 2032[4]

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