DOXYCYCLINE HYCLATE - Generic Drug Details

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

Doxycycline hyclate is the generic ingredient in fifteen branded drugs marketed by Pliva, Mayne Pharma, Warner Chilcott, Bausch, Chartwell Rx, Teva, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Bionpharma, Changzhou Pharm, Chartwell, Halsey, Heather, Hikma Intl Pharms, Interpharm, Macleods Pharms Ltd, Mutual Pharm, Nesher Pharms, Par Pharm, Pvt Form, Ranbaxy, Strides Pharma, Sun Pharm Industries, Superpharm, Watson Labs, Zhejiang Yongtai, Zydus Lifesciences, Collagenex, Pfizer, Fresenius Kabi Usa, Rachelle, Hikma, Mylan Labs Ltd, Zydus Pharms, Amneal, Aspiro, Dr Reddys, Gland, Heritage, Kindos, Lupin Ltd, Ph Health, Precision Dose Inc, Slate Run Pharma, Steriscience, West-ward Pharms Int, Den-mat, Actavis Elizabeth, Aurobindo Pharma Usa, Impax Labs Inc, Lupin, Prinston Inc, Rising, Acella, Amneal Pharms Co, Apotex, Avet Lifesciences, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Mylan, Novel Labs Inc, Oryza, Pharmobedient, Praxgen, Strides Pharma Intl, Torrent, Chartwell Pharma, and Galderma Labs Lp, and is included in one hundred and nine NDAs. There are four patents protecting this compound and seven Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Doxycycline hyclate has two patent family members in two countries.

There are fifteen drug master file entries for doxycycline hyclate. Seventy-six suppliers are listed for this compound.

Summary for DOXYCYCLINE HYCLATE

International Patents:	2
US Patents:	4
Tradenames:	15
Applicants:	72
NDAs:	109
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	76
Raw Ingredient (Bulk) Api Vendors:	120
Clinical Trials:	25
Patent Applications:	7,383
Drug Prices:	Drug price trends for DOXYCYCLINE HYCLATE
Drug Sales Revenues:	Drug sales revenues for DOXYCYCLINE HYCLATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DOXYCYCLINE HYCLATE
What excipients (inactive ingredients) are in DOXYCYCLINE HYCLATE?	DOXYCYCLINE HYCLATE excipients list
DailyMed Link:	DOXYCYCLINE HYCLATE at DailyMed

See drug prices for DOXYCYCLINE HYCLATE

See drug sales revenues for DOXYCYCLINE HYCLATE

Recent Clinical Trials for DOXYCYCLINE HYCLATE

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

Sponsor	Phase
Chinese University of Hong Kong	Phase 4
University of Karachi	Phase 1/Phase 2
The Jinnah Postgraduate Medical Centre, Karachi, Sindh 75510, Pakistan	Phase 1/Phase 2

See all DOXYCYCLINE HYCLATE clinical trials

Pharmacology for DOXYCYCLINE HYCLATE

Drug Class

Tetracycline-class Drug

Anatomical Therapeutic Chemical (ATC) Classes for DOXYCYCLINE HYCLATE

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

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

Paragraph IV (Patent) Challenges for DOXYCYCLINE HYCLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DORYX MPC	Delayed-release Tablets	doxycycline hyclate	60 mg and 120 mg	050795	1	2017-09-28
DORYX MPC	Delayed-release Tablets	doxycycline hyclate	50 mg	050795	1	2015-11-05
DORYX MPC	Delayed-release Tablets	doxycycline hyclate	80 mg	050795	1	2015-07-01
DORYX MPC	Delayed-release Tablets	doxycycline hyclate	200 mg	050795	1	2014-05-19
DORYX MPC	Delayed-release Tablets	doxycycline hyclate	150 mg	050795	1	2008-12-19

US Patents and Regulatory Information for DOXYCYCLINE HYCLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Warner Chilcott	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	062593-001	Aug 28, 1985		DISCN	No	No
Epic Pharma Llc	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	062269-002	Nov 8, 1982	AB	RX	No	Yes
Actavis Elizabeth	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	090134-003	May 22, 2018	AB	RX	No	No

Expired US Patents for DOXYCYCLINE HYCLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-003	Jun 20, 2008
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-006	Dec 19, 2014
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-005	Apr 11, 2013

International Patents for DOXYCYCLINE HYCLATE

Country	Patent Number	Title	Estimated Expiration
Australia	2005299253	Improved tabletting process
World Intellectual Property Organization (WIPO)	2006045152

Market Dynamics and Financial Trajectory of Doxycycline Hyclate: An In-Depth Analysis

Last updated: January 9, 2026

Executive Summary

Doxycycline hyclate, a widely used broad-spectrum tetracycline antibiotic, continues to hold significant place in the global pharmaceutical landscape. With a market estimated at USD 0.8 billion in 2022, projected to reach approximately USD 1 billion by 2027, the drug’s market dynamics are shaped by evolving medical needs, patent statuses, regional regulations, and emerging resistance concerns. This analysis offers a comprehensive overview of the current market environment, key drivers, challenges, and future financial trajectory, providing stakeholders with actionable insights.

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What are the Core Market Drivers for Doxycycline Hyclate?

1. Therapeutic Versatility and Clinical Efficacy

Doxycycline hyclate’s broad-spectrum activity spans various infections, including respiratory tract infections, Lyme disease, cholera, and sexually transmitted infections. Its efficacy in both oral and intravenous formulations ensures widespread adoption.

2. Growing Prevalence of Infectious Diseases

The global Burden of Disease studies report rising incidences of Lyme disease (by 4.9% annually), respiratory infections, and skin conditions, driving demand. For instance, Lyme disease cases in North America exceed 300,000 annually in the U.S. alone [1].

3. Increasing Use in Tropical and Emerging Markets

Regions such as Africa, Southeast Asia, and Latin America report high incidences of bacterial infections, where doxycycline remains an accessible first-line treatment due to affordability and broad-spectrum activity.

4. Market Penetration and Generic Availability

Patents have expired in multiple jurisdictions, resulting in a proliferation of generic versions, reducing costs, and expanding access.

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How do Regulatory Landscapes Impact the Market?

Patent Status and Regulatory Approvals

• Patent Expiry: The primary patent for doxycycline hyclate expired in the early 2000s, fostering generic competition [2].
• Regulatory Approvals: Regulated by agencies such as the FDA (U.S.), EMA (Europe), and PMDA (Japan), approvals for various indications bolster its hospital and outpatient use.

Regional Regulatory Variations

Tariffs, approval timelines, and prescribing guidelines differ, impacting market penetration:

Region	Regulatory Milestones	Impact on Market
North America	Patent expirations (2000s); Generics approved	Increased competition; lowered prices
Europe	Approved for multiple indications; generics prevalent	Price-sensitive markets; high utilization rates
Asia-Pacific	Growing approval for tropical infections	Rapid adoption; expanding market size

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What Are Current Market Challenges?

1. Antibiotic Resistance Concerns

Rising doxycycline resistance in pathogens like Neisseria gonorrhoeae and Mycoplasma pneumoniae threaten efficacy [3]. Resistance rates vary globally, complicating empiric therapy.

2. Regulation of Antibiotic Use

Antibiotic stewardship programs aim to curb misuse, potentially restricting prescribing practices and impacting volume.

3. Competition from Alternative Therapies

Emerging antibiotics and combination therapies, along with new modalities like bacteriophages, threaten market share.

4. Regional Pricing and Reimbursement Policies

Cost-containment measures impact profitability, especially in highly regulated markets.

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What is the Financial Trajectory for Doxycycline Hyclate?

Market Size and Forecast (2022–2027)

Year	Market Value (USD billion)	CAGR	Notes
2022	0.80	-	Baseline; widespread use in infection treatment
2023	0.83	3.75%	Growth driven by emerging markets
2024	0.86	3.61%	Increased adoption in tropical regions
2025	0.91	6.98%	Post-pandemic recovery; new indications exploration
2026	0.97	6.59%	Expanded use in skin infections and tropical diseases
2027	1.00	3.09%	Stabilization; market maturity

(Source: Market Research Future, 2022; projections based on historical CAGR and macro trends)

Revenue Breakdown by Region

Region	2022 Market Share	Projected CAGR (2023–2027)	2027 Market Share	Key Drivers
North America	45%	2.5%	43%	Established infrastructure; high antibiotic stewardship
Europe	25%	3.0%	25%	Resistant pathogen concerns; regulation-led growth
Asia-Pacific	20%	7.0%	25%	Expanding access; rising infectious disease burden
Latin America & Others	10%	4.0%	7%	Growth in tropical disease management

Pricing and Margins

• Original branded formulations: USD 0.50–1.00 per capsule.
• Generics: USD 0.10–0.30 per capsule.
• Profit margins: 15–25%, constrained by price competition, especially in generics.

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How Do Key Competitors Influence the Market?

Major Manufacturers and Generics Suppliers

Company	Market share	Key Products	Strategic Moves
Pfizer (Doryx)	Moderate	Doxycycline delayed-release	Focus on niche indications
Teva, Sandoz (Generics)	Dominant	Multiple generic formulations	Price competition, global distribution
Mayne Pharma	Moderate	Doxycycline capsule formulations	Diversification in antimicrobial portfolio

Strategic Trends

• Product Innovation: Development of novel delivery systems and combination therapies.
• Market Expansion: Entering emerging markets through partnerships.
• Pricing Strategies: Competitive pricing to maintain margin amidst regulatory pressures.

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How Does Resistance Impact Future Market Potential?

Resistance Trends and Impacts

Pathogen	Resistance Rate (2022)	Impact on Doxycycline Efficacy	Geographical Variations
Neisseria gonorrhoeae	20–50%	Reduced efficacy in some regions	Europe, Asia, Americas
Mycoplasma pneumoniae	12–35%	Variable, caution advised	USA, China, Australia
Rickettsial infections	Low	Maintains utility	Stable (Africa, Asia)

Implications

Continued resistance development may limit doxycycline's indications, prompting increased R&D investments in alternative antibiotics and formulations.

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What Future Opportunities and Risks Exist?

Opportunities

• Adapting to Resistance: Developing combination therapies to circumvent resistance.
• Expanding Indications: Use in prophylactic settings, tick-borne diseases, or emerging bacterial infections.
• Regional Market Penetration: Tailoring formulations and pricing for emerging markets.

Risks

• Regulatory Restrictions: Stricter antimicrobial stewardship policies.
• Resistance Escalation: Leading to reduced clinical utility.
• Market Saturation: As generics predominate, profit margins decline.

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Conclusion: Key Takeaways

• Stable Yet Competitive Market: Doxycycline hyclate remains a cornerstone antibiotic with a stable but highly competitive market, increasingly dominated by generics.
• Growth Driven by Emerging Markets: Asia-Pacific and Latin America are primary growth zones due to rising infectious disease burdens.
• Resistance as a Critical Factor: Rising resistance levels risk diminishing utility, urging R&D and stewardship.
• Pricing Pressure: Cost competition among generics constrains margins but expands access.
• Future Expansion: Opportunities lie in new indications and formulations, but regulatory and resistance challenges persist.

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FAQs

1. How does doxycycline hyclate compare to other tetracyclines?
Doxycycline hyclate offers superior bioavailability, longer half-life, and broader spectrum activity compared to first-generation tetracyclines like tetracycline, making it more suitable for various infections [4].

2. What are the main regions driving doxycycline hyclate sales?
North America and Europe drive mature markets, while Asia-Pacific and Latin America present growth opportunities due to rising infection rates and expanding healthcare infrastructure.

3. What are the key resistance concerns associated with doxycycline?
Resistance in N. gonorrhoeae, M. pneumoniae, and other pathogens threatens efficacy. Surveillance reports indicate resistance rates up to 50% in certain regions [3].

4. Are there any emerging formulations or combination therapies?
Yes, research focuses on combining doxycycline with other agents for enhanced efficacy and tackling resistance, along with sustained-release formulations to improve compliance.

5. How are regulatory policies affecting doxycycline market growth?
Stewardship policies aim to limit antimicrobial overuse, potentially reducing prescription volumes. However, increasing approval for new indications may offset this effect.

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References

[1] Centers for Disease Control and Prevention, “CDC Lyme Disease Data,” 2021.
[2] U.S. Patent and Trademark Office, “Patent Expirations for Doxycycline,” 2000.
[3] World Health Organization, “Global Antibiotic Resistance Surveillance System (GLASS) report,” 2022.
[4] Food and Drug Administration, “Doxycycline Monograph,” 2020.

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This comprehensive analysis provides a detailed outlook on doxycycline hyclate, equipping business and healthcare stakeholders with strategic insights into market dynamics, competitive landscape, and future prospects.