DOXYCYCLINE - Generic Drug Details

What are the generic drug sources for doxycycline and what is the scope of patent protection?

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

Doxycycline has eighteen patent family members in eight countries.

There are twenty-eight drug master file entries for doxycycline. Forty-two suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for DOXYCYCLINE

International Patents:	18
US Patents:	10
Tradenames:	18
Applicants:	72
NDAs:	134
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	364
Patent Applications:	6,734
Drug Prices:	Drug price trends for DOXYCYCLINE
Drug Sales Revenues:	Drug sales revenues for DOXYCYCLINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DOXYCYCLINE
What excipients (inactive ingredients) are in DOXYCYCLINE?	DOXYCYCLINE excipients list
DailyMed Link:	DOXYCYCLINE at DailyMed

See drug prices for DOXYCYCLINE

See drug sales revenues for DOXYCYCLINE

Recent Clinical Trials for DOXYCYCLINE

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

Sponsor	Phase
Chinese University of Hong Kong	Phase 4
Mahidol Oxford Tropical Medicine Research Unit	Phase 2/Phase 3
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit	Phase 2/Phase 3

See all DOXYCYCLINE clinical trials

Generic filers with tentative approvals for DOXYCYCLINE

Applicant	Application No.	Strength	Dosage Form
		40MG	CAPSULE;ORAL
		40MG	CAPSULE; ORAL
		40MG	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for DOXYCYCLINE

Drug Class

Tetracycline-class Drug

Medical Subject Heading (MeSH) Categories for DOXYCYCLINE

Anti-Bacterial Agents

Antimalarials

Anatomical Therapeutic Chemical (ATC) Classes for DOXYCYCLINE

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORACEA	Delayed-release Capsules	doxycycline	40 mg	050805	1	2008-12-12

US Patents and Regulatory Information for DOXYCYCLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acella	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	210664-001	Mar 16, 2020	AB	RX	No	No
Superpharm	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	062469-002	Oct 31, 1984		DISCN	No	No
Mayne Pharma	DORYX MPC	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-008	May 20, 2016		DISCN	Yes	No	8,715,724		Y
Lupin Ltd	DOXYCYCLINE	doxycycline	CAPSULE;ORAL	204234-002	Mar 5, 2014	AB	RX	No	No

Expired US Patents for DOXYCYCLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	8,709,478
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	7,232,572
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	8,603,506
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	10,058,564

EU/EMA Drug Approvals for DOXYCYCLINE

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

International Patents for DOXYCYCLINE

Country	Patent Number	Title	Estimated Expiration
Spain	2534827
Spain	2391385
Poland	2204168
Japan	5586123

DOXYCYCLINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Doxycycline

Introduction

Doxycycline, a broad-spectrum antibiotic, has been a cornerstone in the treatment of various bacterial infections, including acne, malaria, and sexually transmitted infections (STIs). The market for doxycycline, particularly its hyclate form, is experiencing significant growth driven by several key factors.

Market Size and Growth Projections

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:

Broad-Spectrum Efficacy

Doxycycline's effectiveness against a wide range of bacterial diseases, including respiratory and urinary tract infections, makes it a preferred choice among healthcare professionals[1].

Increasing Prevalence of Infectious Diseases

The rising incidence of infectious disorders, such as acne and malaria, and the growing awareness of STIs are significant growth drivers. The drug's role in controlling parasite illnesses like malaria further boosts its demand[1].

Advancements in Pharmaceutical Formulations

Improvements in pharmaceutical formulations and the development of new products, such as generic versions of doxycycline hyclate tablets and capsules, are enhancing market prospects. For instance, Lupin Limited recently launched a generic version of Oracea® (Doxycycline Capsules, 40 mg) in the United States, which has been well-received[2].

Healthcare Infrastructure and Public Awareness

Advancements in healthcare infrastructure and increased public awareness, especially in developing nations, are contributing to the market's expansion. Government initiatives for regulatory approvals and awareness campaigns about bacterial infection treatments are also providing lucrative opportunities[1][4].

Market Segmentation

The doxycycline hyclate market is segmented based on:

Application

• Antibiotics
• Acne Treatment
• Malaria Treatment
• Veterinary Medicine[1]

Product Form

• Tablets
• Capsules
• Powder
• Injection Formulations[1]

Geographical Regions

• North America
• Europe
• Asia-Pacific
• South America
• Middle-East and Africa[1]

Pricing Dynamics

The prices of doxycycline hyclate have experienced significant fluctuations in recent years. Between 2011 and 2013, the mean cost of doxycycline hyclate prescriptions increased dramatically from $7.16 to $139.89, with a corresponding increase in out-of-pocket costs. This increase is attributed to noncompetitive market forces rather than traditional market dynamics[3].

In 2024, the prices of doxycycline hydrochloride are expected to rise due to consistent demand from healthcare and pharmaceutical sectors, coupled with supply limitations and logistical bottlenecks. Global shipping delays and geopolitical tensions, such as those between Iran and Israel, are further complicating the supply chain and driving prices higher[2].

Competitive Landscape

The market is highly competitive, with several key players including:

• Lupin Limited
• Alembic Pharmaceuticals
• Sun Pharmaceutical
• Mylan
• Ajanta Pharma
• Teva
• Zydus Pharmaceuticals
• G&W Laboratories
• Mayne Pharma
• Almirall[4]

These companies are actively involved in launching new products and formulations, which is intensifying the competition and influencing market dynamics.

Challenges and Restraints

Despite the growth, the market faces several challenges:

Adverse Effects

Adverse effects associated with doxycycline, such as gastrointestinal issues and photosensitivity, can hinder market growth[4].

Alternative Treatments

The presence of alternative treatments for bacterial infections can also act as a restraint[4].

Supply Chain Disruptions

Global shipping delays, logistical bottlenecks, and geopolitical tensions can disrupt the supply chain, leading to price increases and availability issues[2].

Future Outlook and Trends

New Product Launches

The launch of new products, such as generic versions of doxycycline hyclate tablets and capsules, is expected to flourish the market. For example, Alembic Pharma's generic doxycycline hyclate tablets and Lupin's doxycycline hyclate capsules have been well-received in the market[2][4].

Increased Demand for Minimally Invasive Treatments

The surge in demand for minimally invasive treatment procedures and cost-effective treatments is expected to boost the market growth[4].

Government Initiatives

Government initiatives for regulatory approvals and spreading awareness about bacterial infection treatments are expected to offer lucrative opportunities for market expansion[4].

Financial Impact and Revenue

The financial impact of doxycycline hyclate is significant, with products like Oracea (Doxycycline capsules) generating an estimated annual revenue of $128 million in the US alone[2].

Key Takeaways

• The doxycycline hyclate market is projected to grow from USD 1.2 billion in 2023 to USD 1.8 billion by 2031.
• Broad-spectrum efficacy, increasing prevalence of infectious diseases, and advancements in pharmaceutical formulations are key growth drivers.
• Pricing dynamics are influenced by supply chain disruptions, geopolitical tensions, and noncompetitive market forces.
• The market is highly competitive with several key players launching new products.
• Challenges include adverse effects, alternative treatments, and supply chain disruptions.

FAQs

1. What is the projected growth rate of the doxycycline hyclate market?

   • The doxycycline hyclate market is expected to grow at a CAGR of 4.5% from 2024 to 2031[1].

2. What are the main drivers of the doxycycline hyclate market?

   • The main drivers include broad-spectrum efficacy, increasing prevalence of infectious diseases, advancements in pharmaceutical formulations, and increased public awareness[1].

3. Which companies are key players in the doxycycline hyclate market?

   • Key players include Lupin Limited, Alembic Pharmaceuticals, Sun Pharmaceutical, Mylan, and others[4].

4. What are the challenges facing the doxycycline hyclate market?

   • Challenges include adverse effects, alternative treatments, and supply chain disruptions due to global shipping delays and geopolitical tensions[2][4].

5. How is the pricing of doxycycline hyclate affected?

   • Pricing is affected by supply chain disruptions, geopolitical tensions, and noncompetitive market forces, leading to significant price increases in recent years[2][3].

Sources

1. Market Research Intellect: Doxycycline Hyclate Market Size, Share & Growth [2024-2031][1].
2. ChemAnalyst: Increased Demand and Limited Supply to Push Up Doxycycline Hydrochloride Prices[2].
3. PubMed: Influence of Market Competition on Tetracycline Pricing and Impact on Prescribing Practices[3].
4. Allied Market Research: Oral Doxycycline Hyclate Market Size | Industry Growth By, 2030[4].