DEMECLOCYCLINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for demeclocycline hydrochloride and what is the scope of freedom to operate?

Demeclocycline hydrochloride is the generic ingredient in two branded drugs marketed by Lederle, Corepharma, Amneal Pharm, Barr, Epic Pharma Llc, and Impax Labs, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for demeclocycline hydrochloride. Five suppliers are listed for this compound.

Summary for DEMECLOCYCLINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	8
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	6
Patent Applications:	1,783
What excipients (inactive ingredients) are in DEMECLOCYCLINE HYDROCHLORIDE?	DEMECLOCYCLINE HYDROCHLORIDE excipients list
DailyMed Link:	DEMECLOCYCLINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DEMECLOCYCLINE HYDROCHLORIDE

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

Sponsor	Phase
Mansoura University	PHASE2
Massachusetts General Hospital	Phase 1
Federal University of São Paulo	Phase 4

See all DEMECLOCYCLINE HYDROCHLORIDE clinical trials

Pharmacology for DEMECLOCYCLINE HYDROCHLORIDE

Drug Class

Tetracycline-class Antimicrobial

Medical Subject Heading (MeSH) Categories for DEMECLOCYCLINE HYDROCHLORIDE

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for DEMECLOCYCLINE HYDROCHLORIDE

D06AA	Tetracycline and derivatives
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for DEMECLOCYCLINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharm	DEMECLOCYCLINE HYDROCHLORIDE	demeclocycline hydrochloride	TABLET;ORAL	065425-001	Feb 27, 2008	AB	RX	No	No
Lederle	DECLOMYCIN	demeclocycline hydrochloride	SYRUP;ORAL	050257-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Barr	DEMECLOCYCLINE HYDROCHLORIDE	demeclocycline hydrochloride	TABLET;ORAL	065171-002	Dec 13, 2004		DISCN	No	No
Corepharma	DECLOMYCIN	demeclocycline hydrochloride	TABLET;ORAL	050261-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Epic Pharma Llc	DEMECLOCYCLINE HYDROCHLORIDE	demeclocycline hydrochloride	TABLET;ORAL	065447-002	Aug 18, 2015	AB	RX	No	No

Market Dynamics and Financial Trajectory for Demecycline Hydrochloride

Last updated: July 27, 2025

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Introduction

Demecycline Hydrochloride is a semi-synthetic tetracycline antibiotic primarily employed in the treatment of a broad spectrum of bacterial infections. As part of the broader antibiotic market, its market dynamics are influenced by factors such as antimicrobial resistance trends, regulatory pathways, and competitive landscape. Given the ongoing global health focus on combating infectious diseases, understanding the drug’s market trajectory provides strategic insights for stakeholders, including pharmaceutical companies, investors, and healthcare policymakers.

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Pharmacological Profile and Therapeutic Significance

Demecycline Hydrochloride functions by inhibiting bacterial protein synthesis through binding to the 30S ribosomal subunit. Its spectrum covers Gram-positive and Gram-negative bacteria, making it valuable in respiratory infections, urinary tract infections, and certain sexually transmitted infections. Its pharmacokinetics, characterized by high oral bioavailability and a favorable safety profile, support its clinical utility. However, the rise of tetracycline-resistant bacterial strains poses a challenge to its sustained efficacy.

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Market Landscape and Competitive Environment

Historical Market Trends

The tetracycline class has experienced fluctuating demand over the past decade, driven by increasing antibiotic resistance and regulatory restrictions on older antibiotics. Demand for Demecycline Hydrochloride, in particular, remains niche, often limited by competition from broad-spectrum agents such as doxycycline and minocycline. Regulatory approvals for generic versions have proliferated, dampening prices and margins.

Current Market Players

Major pharmaceutical manufacturers involved in Demecycline Hydrochloride production include generic drug firms with established tetracycline manufacturing capabilities. Companies often leverage existing antibiotic production infrastructure to develop formulations. Patent statuses vary; while primary patents have expired, certain formulations or delivery mechanisms may still be under protection.

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Market Drivers Influencing Growth and Adoption

1. Antimicrobial Resistance (AMR): Rising AMR rates have both constricted and created opportunities. While resistance reduces efficacy, it simultaneously renews interest in antibiotics with unique properties or combination potential.

2. Regulatory Environment: Stringent approval processes, especially within the US FDA and EMA, influence entry barriers. Approval of new formulations, generics, or combination therapies can stimulate market growth.

3. Healthcare Needs: Increased global burden of bacterial infections, especially in developing regions, sustains demand for affordable antibiotics like Demecycline Hydrochloride.

4. R&D Investments: Structural shifts in R&D focus toward overcoming resistance, such as developing derivatives or novel delivery systems, may enhance market viability.

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Challenges and Constraints

• Antibiotic Stewardship: Growing concern over antibiotic overuse and stewardship policies limit prescription volumes, affecting revenue streams.
• Resistance Development: Emergence of tetracycline-resistant strains restricts efficacy and demands novel formulations or alternative therapies.
• Pricing Pressures: Generics dominance sustains low prices, constraining profit margins.
• Supply Chain Concerns: Raw material availability for tetracycline synthesis, including specific intermediates, influences manufacturing stability.

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Financial Trajectory and Revenue Forecast

Historical Revenue Indicators

Data from global generics markets indicates tetracycline antibiotics generally experience flat or declining revenues driven by resistance and generic price erosion. For Demecycline Hydrochloride specifically, financial reports are sparse, but assumptions can be made based on similar antibiotics.

Projected Future Outlook (2023-2030)

Year	Estimated Growth Rate	Key Factors	Revenue Outlook
2023	-2% to 0%	Market saturation, resistance concerns	Stable, marginal decline
2024-2025	-1% to +2%	Disruptive R&D, new formulations, resistant strain management	Slight recovery driven by niche applications
2026-2030	0% to +3%	Potential approval of combination therapies or reformulations	Gradual stabilization, possible growth in niche markets

Overall, the financial trajectory hinges on strategic R&D investments, resistance management, and regulatory changes. Margins are likely to remain constrained, emphasizing cost efficiencies and niche market identification.

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Regulatory and Patent Outlook

Most formulations of Demecycline Hydrochloride are off-patent, enhancing affordability and market penetration. Future growth may depend on regulatory approvals for new indications or formulations. Intellectual property protections could influence development pathways, especially for combination therapies or delivery innovations.

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Emerging Trends and Opportunities

• Combination Antibiotics: Synergistic formulations combining Demecycline Hydrochloride with other agents could reinvigorate sales, particularly against resistant strains.
• Formulation Innovations: Long-acting or targeted delivery systems may improve patient compliance and extend product life cycles.
• Biopharmaceutical Partnerships: Collaborations with biotech firms focusing on resistance mechanisms could facilitate novel uses or enhanced formulations.

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Conclusion

The market dynamics for Demecycline Hydrochloride are characterized by a mature, highly competitive landscape with limited growth but sustained niche demand driven by specific bacterial infections and resistance management needs. The financial trajectory will largely depend on R&D investment strategies, regulatory pathways, and the evolving resistance profile of target bacteria. Market participants should consider harnessing innovation in formulations and combination therapies, focusing on regions with high infection burdens and less saturated antibiotic markets.

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Key Takeaways

• Limited but Stable Market: Demecycline Hydrochloride faces commoditization pressures but maintains niche relevance due to its antimicrobial spectrum.
• Resistance and Stewardship Effects: Rising resistance reduces long-term utility, yet stewardship policies can promote targeted use, creating opportunities.
• Innovation as a Growth Lever: Developing novel formulations or combination therapies could counteract erosion from generics and resistance issues.
• Regulatory Environment: Off-patent status facilitates generic competition but also necessitates differentiation through formulations or new uses.
• Investment Focus: Companies should align R&D with resistance trends and regional infection burdens to optimize financial outcomes.

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FAQs

Q1: What is the primary therapeutic application of Demecycline Hydrochloride?
Demecycline Hydrochloride is mainly used to treat bacterial infections such as respiratory, urinary tract, and sexually transmitted infections, owing to its broad-spectrum activity.

Q2: How does antibiotic resistance impact the market for Demecycline Hydrochloride?
Resistance reduces the drug’s efficacy, leading to decreased prescriptions and revenues. However, resistance also spurs research into combination therapies and formulations to extend its utility.

Q3: Are there patent protections currently in place for Demecycline Hydrochloride formulations?
Most formulations are off-patent, increasing market competition but also enabling affordability. Future innovations could secure new patent protections.

Q4: What are key opportunities for growth in the Demecycline Hydrochloride market?
Innovations in formulation, combination therapies, and targeting resistant strains present potential growth avenues.

Q5: How do regulatory policies influence the market trajectory of Demecycline Hydrochloride?
Regulatory approvals and restrictions shape market access, especially for novel formulations or new indications, thereby affecting sales and profitability.

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References

1. [Relevant Pharmacological Data and Trends in Antibiotics]
2. [Global Antibiotic Market Analysis Reports]
3. [Regulatory Guidelines for Antibiotic Approvals]
4. [Epidemiological Studies on Bacterial Resistance Patterns]
5. [Industry Reports on Generic Antibiotics Market Dynamics]