Clarithromycin - Generic Drug Details

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

Clarithromycin is the generic ingredient in three branded drugs marketed by Abbvie, Sandoz, Sun Pharm Inds Ltd, Actavis Labs Fl Inc, Ani Pharms, Dr Reddys Labs Sa, Lupin Ltd, Nostrum Labs Inc, Ranbaxy, Sunshine, Ajanta Pharma Ltd, Alembic, Aurobindo, Chartwell, Esjay Pharma, Hec Pharm, Hikma, Ivax Sub Teva Pharms, Norvium Bioscience, Teva, and Wockhardt, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for clarithromycin. Twenty-eight suppliers are listed for this compound.

Summary for clarithromycin

US Patents:	0
Tradenames:	3
Applicants:	21
NDAs:	26
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	394
Patent Applications:	6,943
Drug Prices:	Drug price trends for clarithromycin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for clarithromycin
What excipients (inactive ingredients) are in clarithromycin?	clarithromycin excipients list
DailyMed Link:	clarithromycin at DailyMed

See drug prices for clarithromycin

See drug sales revenues for clarithromycin

Recent Clinical Trials for clarithromycin

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

Sponsor	Phase
Alexandria University	Phase 3
Fu Jen Catholic University Hospital	Phase 4
Fifth Affiliated Hospital, Sun Yat-Sen University	Phase 1

See all clarithromycin clinical trials

Pharmacology for clarithromycin

Drug Class	Macrolide Antimicrobial
Mechanism of Action	Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for clarithromycin

Anti-Bacterial Agents

Cytochrome P-450 CYP3A Inhibitors

Protein Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for clarithromycin

J01FA	Macrolides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for clarithromycin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell	CLARITHROMYCIN	clarithromycin	TABLET;ORAL	065384-001	Aug 20, 2007	AB	RX	No	No
Norvium Bioscience	CLARITHROMYCIN	clarithromycin	TABLET;ORAL	065195-002	Mar 11, 2005		DISCN	No	No
Ranbaxy	CLARITHROMYCIN	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	065210-001	Jan 26, 2005		DISCN	No	No
Lupin Ltd	CLARITHROMYCIN	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	202532-001	Sep 15, 2015		DISCN	No	No
Wockhardt	CLARITHROMYCIN	clarithromycin	TABLET;ORAL	065266-002	May 31, 2006		DISCN	No	No
Hec Pharm	CLARITHROMYCIN	clarithromycin	TABLET;ORAL	203584-002	Sep 28, 2015	AB	RX	No	No

Expired US Patents for clarithromycin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	BIAXIN XL	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	050775-001	Mar 3, 2000
Abbvie	BIAXIN XL	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	050775-001	Mar 3, 2000
Abbvie	BIAXIN XL	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	050775-001	Mar 3, 2000

Clarithromycin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Clarithromycin Tablets

Market Size and Growth

The clarithromycin tablets market has been experiencing robust growth in recent years. As of 2023, the market size was valued at $1.91 billion and is projected to increase to $2.09 billion in 2024, reflecting a compound annual growth rate (CAGR) of 9.3%[2][5].

By 2028, the market is expected to reach $2.99 billion, maintaining a CAGR of 9.4% during the forecast period. This strong growth is driven by several key factors, including the rising global burden of infections, increasing gastrointestinal infections, and the growing use of clarithromycin in combination therapies[1][3][5].

Market Segmentation

The clarithromycin tablets market is segmented based on several criteria:

By Type

The market is divided into 250 mg and 500 mg tablets. The 250 mg tablets segment is anticipated to register significant revenue growth due to its increased efficacy in treating mild-to-moderate bacterial infections and higher bioavailability[1][3].

By Distribution Channel

The distribution channels include hospital pharmacies, online pharmacies, retail pharmacies, and clinics. Clinics are expected to account for a significant share of the market, with over 55% of clarithromycin prescriptions dispensed through outpatient clinics and physician offices in the U.S. in 2023[5].

By Application

The applications of clarithromycin tablets span various medical fields, including dermatology, ear, nose, and throat (ENT), thoracic and cardiovascular, pediatric, and pulmonary medicine. The rising incidence of respiratory infections, such as pneumonia and bronchitis, is a key driver in the pulmonary medicine segment[1][3].

Drivers of the Market

Several factors are driving the growth of the clarithromycin tablets market:

• Rising Global Burden of Infections: The increasing incidence of bacterial infections globally is a significant driver.
• Helicobacter pylori Infections: The rise in H. pylori infections, particularly in North America, where clarithromycin-based triple therapy is the recommended treatment, contributes to market growth[1][5].
• Respiratory Diseases: The growing caseload of respiratory diseases, such as pneumonia and bronchitis, especially in the Asia Pacific region, is another key factor[3][5].
• Generic Versions and Combination Therapies: The availability of generic versions of clarithromycin and its increasing use in combination therapies further boost market growth[1][3].

Restraints of the Market

Despite the strong growth, there are several restraints to consider:

• Antibiotic Resistance: The rise in antibiotic resistance poses a significant challenge to the market.
• Regulatory Frameworks: Stringent regulatory approvals, particularly in regions like North America, can slow down market growth[1][5].

Regional Analysis

The market is geographically diverse, with different regions contributing significantly:

North America

North America dominates the clarithromycin tablets market, driven by a robust healthcare infrastructure, high prevalence of respiratory infections, and the availability of advanced diagnostic tools. The U.S. accounted for over 40% of global clarithromycin tablets sales in 2023[5].

Asia Pacific

The Asia Pacific region is experiencing rapid growth, driven by the increasing prevalence of respiratory infections and the growing demand for effective antimicrobial treatments. The region is expected to grow at a CAGR of 8.2% from 2023 to 2028[5].

Technological Advancements and Innovations

Technological advancements and innovations are crucial for the market's growth:

• New Formulations and Combinations: Research into new clarithromycin formulations and combinations is expected to drive market growth.
• Extended-Release Versions: Innovations in extended-release versions of clarithromycin enhance its efficacy and patient compliance.
• Manufacturing Processes: Technological advancements in manufacturing processes are also contributing to the market's expansion[1][3][5].

Competitive Landscape

The clarithromycin tablets market is highly competitive, with various players adopting strategic plans such as collaborations, mergers, acquisitions, and political support to solidify their market presence. Key players include Mylan Pharmaceuticals and Pfizer, which have recently expanded their distribution networks and manufacturing capacities[5].

Financial Projections

The financial trajectory of the clarithromycin tablets market is promising:

• By 2028, the market is expected to reach $2.99 billion.
• By 2031, the market valuation is projected to be around $2.9 billion, growing at a CAGR of 6.9% from 2024 to 2031[5].

Key Takeaways

• The clarithromycin tablets market is experiencing strong growth driven by rising infections and respiratory diseases.
• The 250 mg tablets segment is expected to see significant revenue growth.
• North America and the Asia Pacific region are key markets due to their robust healthcare infrastructure and growing demand for antimicrobial treatments.
• Technological advancements and innovations in drug formulations are crucial for market growth.
• The market is highly competitive, with major players focusing on strategic expansions and product innovations.

FAQs

1. What is the current market size of the clarithromycin tablets market?

   • The current market size of the clarithromycin tablets market was $1.91 billion in 2023[2].

2. What is the projected growth rate of the clarithromycin tablets market?

   • The market is expected to grow at a CAGR of 9.4% from 2023 to 2028[1].

3. Which segment is expected to register significant revenue growth in the clarithromycin tablets market?

   • The 250 mg tablets segment is anticipated to register significant revenue growth due to its increased efficacy and higher bioavailability[3].

4. What are the major distribution channels for clarithromycin tablets?

   • The major distribution channels include hospital pharmacies, online pharmacies, retail pharmacies, and clinics, with clinics accounting for a significant share[5].

5. Which region dominates the clarithromycin tablets market?

   • North America currently dominates the market, driven by a robust healthcare infrastructure and high prevalence of respiratory infections[5].

Cited Sources:

1. The Business Research Company. Clarithromycin Tablets Global Market Report 2024.
2. The Business Research Company. Global Clarithromycin Tablets Market Size Forecast 2024.
3. Reports and Data. Clarithromycin Tablets Market Growth & Analysis.
4. PubMed. Clarithromycin for safe and cost-effective reduction of cyclosporine.
5. Verified Market Research. Clarithromycin Tablets Market Size, Share, Trends & Forecast.