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, Changzhou Pharm, Chartwell, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Nostrum Labs Inc, 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, Endo Operations, Gland Pharma Ltd, Heritage, Kindos, Lupin Ltd, Slate Run Pharma, West-ward Pharms Int, Den-mat, Actavis Elizabeth, Aurobindo Pharma Usa, Impax Labs Inc, Lupin, Prinston Inc, Rising, Acella, Amneal, Amneal Pharms Co, Apotex, Avet Lifesciences, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Larken Labs, Mylan, Novel Labs Inc, Oryza, Praxgen, Torrent, Chartwell Pharma, and Galderma Labs Lp, and is included in one hundred and two 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-four suppliers are listed for this compound.

Summary for DOXYCYCLINE HYCLATE

International Patents:	2
US Patents:	4
Tradenames:	15
Applicants:	66
NDAs:	102
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	74
Raw Ingredient (Bulk) Api Vendors:	194
Clinical Trials:	25
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
The Jinnah Postgraduate Medical Centre, Karachi, Sindh 75510, Pakistan	Phase 1/Phase 2
Zhuzhou Qianjin Pharmaceutical Co., Ltd., 801, Zhuzhou, China	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
Rising	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	090431-002	Dec 28, 2010		DISCN	No	No
Rising	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	209987-001	Oct 5, 2020		DISCN	No	No
Alembic	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	210527-002	Jun 13, 2018	AB	RX	No	No
Alembic	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	211744-001	Jun 30, 2020	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 MPC	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-007	May 20, 2016
Mayne Pharma	DORYX MPC	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-008	May 20, 2016

International Patents for DOXYCYCLINE HYCLATE

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

DOXYCYCLINE HYCLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of 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, market competition, and healthcare trends. Here, we delve into the market dynamics and financial trajectory of doxycycline hyclate.

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][4].

Segmentation and Applications

The market is segmented based on application, product form, and geographical regions. Key applications include antibiotics, acne treatment, malaria treatment, and veterinary medicine. The product forms include tablets, capsules, powder, and injection formulations. Geographically, the market spans North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[1][4].

Drivers of Market Growth

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

• Broad-Spectrum Efficacy: Doxycycline hyclate is effective against a wide range of bacterial diseases, including respiratory and urinary tract infections, making it a preferred choice among healthcare professionals[1].
• Acne and Malaria Treatment: The drug's effectiveness in treating acne and malaria contributes significantly to its demand. The rising prevalence of acne and the need for efficient treatment alternatives further boost market growth[1][2].
• Increasing Infectious Diseases: The growing incidence of infectious disorders and heightened awareness of STDs, particularly in developing nations, are key growth factors[1].
• Advancements in Pharmaceutical Formulations: Improvements in pharmaceutical formulations and increased accessibility in both developed and developing countries are also driving market expansion[1].

Financial Trajectory

Historical Price Trends

Between 2011 and 2013, the mean cost of doxycycline hyclate prescriptions saw a dramatic increase from $7.16 to $139.89, with a corresponding rise in out-of-pocket costs. This increase was not observed in other tetracyclines like doxycycline monohydrate or minocycline, suggesting noncompetitive market forces may be at play[3].

Current Pricing and Cost Factors

The cost of doxycycline hyclate can vary based on the form and strength of the drug. It is available as generic and brand-name versions, with generics generally being more affordable. Factors influencing the cost include treatment plan, insurance coverage, and the pharmacy used. For instance, injectable forms may require additional costs for office visits[2].

Impact of Market Competition

Despite the significant price increase between 2011 and 2013, there was no substantial change in prescribing behavior, indicating that clinicians did not switch to less costly alternatives. This suggests that market competition did not play a significant role in the price increase, and noncompetitive forces may have been responsible[3].

Regional Analysis

The market for doxycycline hyclate is diverse and spread across various regions:

• North America and Europe: These regions have well-established healthcare infrastructures, contributing to higher market shares.
• Asia-Pacific: This region is expected to see significant growth due to increasing healthcare spending and a large patient population.
• South America and Middle-East and Africa: These regions are also experiencing growth, driven by improving healthcare access and rising awareness of infectious diseases[1][4].

Competitive Landscape

Key players in the doxycycline hyclate market include Jiangsu Lianhuan Pharma, Spansules Pharma, and others. These companies are focusing on strategy building models to strengthen their product portfolios and expand their business globally[4].

Market Trends and Opportunities

• Innovative Formulations: The development of new formulations, such as capsules and injectable solutions, is enhancing market prospects.
• Antibiotic Stewardship: Efforts to promote responsible use of antibiotics are also driving the market, as doxycycline hyclate is seen as a reliable and effective option[1].
• Public Health Initiatives: Initiatives to prevent and treat bacterial STIs, such as doxycycline postexposure prophylaxis, are gaining traction, particularly among high-risk populations[5].

Challenges and Restraints

• Price Volatility: The historical price volatility of doxycycline hyclate can affect market stability and patient access.
• Antimicrobial Resistance: The growing concern of antimicrobial resistance could impact the long-term efficacy and demand for doxycycline hyclate[3][5].

Conclusion

The doxycycline hyclate market is poised for significant growth driven by its broad-spectrum efficacy, increasing demand for acne and malaria treatments, and advancements in pharmaceutical formulations. However, the market faces challenges such as price volatility and the threat of antimicrobial resistance.

Key Takeaways

• The doxycycline hyclate market is expected to grow from USD 1.2 billion in 2023 to USD 1.8 billion by 2031.
• The market is driven by its efficacy in treating various bacterial infections, acne, and malaria.
• Price trends have been volatile, with significant increases observed in the past.
• Regional growth varies, with Asia-Pacific expected to see significant expansion.
• Key players are focusing on innovative formulations and expanding their global presence.

FAQs

Q: What are the primary applications of doxycycline hyclate? A: Doxycycline hyclate is primarily used to treat bacterial infections, acne, malaria, and in veterinary medicine[1][2].

Q: How is the cost of doxycycline hyclate affected by its form and strength? A: The cost of doxycycline hyclate varies based on the form (tablets, capsules, powder, injection) and strength of the drug. Generic forms are generally more affordable than brand-name versions[2].

Q: What factors contributed to the significant price increase of doxycycline hyclate between 2011 and 2013? A: The price increase was not easily explained by competitive market forces, suggesting noncompetitive market forces may have been responsible[3].

Q: How does the regional analysis impact the market for doxycycline hyclate? A: The market is diverse across regions, with North America and Europe having established healthcare infrastructures, and Asia-Pacific expected to see significant growth due to increasing healthcare spending[1][4].

Q: What are the key trends and opportunities in the doxycycline hyclate market? A: Trends include the development of innovative formulations, antibiotic stewardship, and public health initiatives such as doxycycline postexposure prophylaxis for STIs[1][5].

Sources

1. Market Research Intellect: Doxycycline Hyclate Market Size, Share & Growth [2024-2031][1].
2. Healthline: Doxycycline Cost, Coupons, and Financial Assistance[2].
3. PubMed: Influence of Market Competition on Tetracycline Pricing and Impact[3].
4. Cognitive Market Research: Doxycycline Hyclate Market Report 2024 (Global Edition)[4].
5. Oxford Academic: Filling in the Gaps: Updates on Doxycycline Prophylaxis for Bacterial STIs[5].