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, Mpp Pharma, Ranbaxy, Sunshine, Alembic, Aurobindo, Chartwell, Hec Pharm, Hikma, Ivax Sub Teva Pharms, Jubilant Cadista, Novitium Pharma, Pharmobedient, 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-seven 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:	27
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	435
Patent Applications:	5,839
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
Samsung Medical Center	PHASE4
Rehman Medical Institute - RMI	PHASE4
Tanta University	NA

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
Aurobindo	CLARITHROMYCIN	clarithromycin	TABLET;ORAL	065489-001	Jul 25, 2012	AB	RX	No	Yes
Pharmobedient	CLARITHROMYCIN	clarithromycin	TABLET;ORAL	065195-002	Mar 11, 2005		DISCN	No	No
Jubilant Cadista	CLARITHROMYCIN	clarithromycin	TABLET;ORAL	206714-001	Apr 25, 2019		DISCN	No	No
Abbvie	BIAXIN	clarithromycin	TABLET;ORAL	050662-002	Oct 31, 1991		DISCN	Yes	No
Hikma	CLARITHROMYCIN	clarithromycin	TABLET;ORAL	065178-002	May 25, 2004		DISCN	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	6,010,718
Abbvie	BIAXIN XL	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	050775-001	Mar 3, 2000	6,552,616
Abbvie	BIAXIN XL	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	050775-001	Mar 3, 2000	6,551,616

Market Dynamics and Financial Trajectory for Clarithromycin

Last updated: July 27, 2025

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Introduction

Clarithromycin, a macrolide antibiotic developed by Abbott Laboratories and later marketed by AbbVie, remains a key player in infectious disease treatment. Its broad-spectrum activity, particularly against respiratory, skin, and Helicobacter pylori-related infections, has sustained prolongs market relevance despite increasing competition and evolving healthcare paradigms. This analysis explores the intricate market dynamics shaping clarithromycin's trajectory, recent and forecasted financial performance, and strategic factors influencing its future.

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Historical Context and Patent Landscape

Clarithromycin received FDA approval in 1991, establishing itself as an essential antimicrobial agent. Originally branded as Biaxin®, it enjoyed robust market exclusivity. Patent protections largely protected its formulations until the early 2010s, after which patent expirations catalyzed generic entry. Generics have significantly reduced prices and market share concentration, intensifying competition (Source: FDA Orange Book).

In recent years, patent challenges and biosimilar developments have pressured branded versions, carving out a more competitive landscape. Notably, the expiration of key patents in North America and Europe from 2015 to 2020 led to a surge of generic clarithromycin products, diluting revenues for originator companies.

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Market Drivers Influencing Clarithromycin

Clinical Efficacy and Usage Trends

Clarithromycin’s efficacy against H. pylori has cemented its utility in eradication therapies globally. Its utility in respiratory tract infections, including bronchitis and pneumonia, sustains consistent demand. However, rising antibiotic resistance diminishes its effectiveness, prompting shifts toward alternative therapies.

Antibiotic Resistance Challenges

The escalation of clarithromycin-resistant Helicobacter pylori strains represents a pivotal challenge. Resistance rates in certain regions (e.g., Europe and Asia) now exceed 15%, reducing eradication success and discouraging empirical use (Source: WHO). Consequently, the clinical reliance on clarithromycin for first-line therapy is waning, impacting its revenue potential.

Regulatory and Prescribing Trends

Regulatory agencies increasingly advocate stewardship to curb antibiotic resistance, emphasizing narrow-spectrum agents and tailored therapy. This shift constrains clarithromycin’s first-line prescriptions, favoring newer agents with improved resistance profiles, such as levofloxacin-based regimens or newer macrolides and biologics.

Emerging Alternatives and Therapies

Advancements in the treatment landscape, including novel antibiotics and acid-suppressive agents, threaten clarithromycin’s market share. Additionally, probiotic and phage therapy research presents alternative routes to manage bacterial infections, potentially reducing dependence on traditional antibiotics.

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Financial Performance and Market Size

Market Scale and Regional Dynamics

The global clarithromycin market was valued at approximately USD 0.7 billion in 2022, with North America, Europe, and Asia representing key consumption regions. North America historically dominated the market, but recent proliferation of generics and resistance challenges have tempered growth. Asia-Pacific exhibits the highest growth rate, driven by increasing infectious disease burden, expanding healthcare infrastructure, and generic availability.

Revenue Trends and Key Players

The original brand, Biaxin®, along with generics, accounts for the majority of sales. Post-patent expiry, generic manufacturers such as Apotex, Teva Pharmaceutical Industries, and local Asian producers have captured significant market share, leading to a price erosion estimated at 60-70%. This decline has compressed profit margins for originators.

Regional Regulatory Impact

Stringent regulation in the US and Europe has delayed the approval of new formulations or redesigned dosage forms, limiting the expansion of clarithromycin’s portfolio. Conversely, in regions with less regulatory saturation, market penetration remains robust, albeit with increasing scrutiny over antibiotic stewardship.

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Future Market Outlook

Resistance Trends and Prescribing Adjustments

Rising resistance diminishes clarithromycin’s utility, prompting clinicians to switch to alternative regimens or second-line therapies. According to a recent study, resistance rates to clarithromycin in H. pylori infections have grown by an annual average of 2-3% over the past decade. As a result, the use of clarithromycin-based therapies is projected to decline, especially in high-resistance regions.

New Formulations and Combination Therapies

Efforts to develop combination therapies that include clarithromycin aim to overcome resistance issues. However, clinical success is limited, and regulatory approval for novel formulations faces hurdles. The strategic focus is shifting toward molecules with novel mechanisms of action and better resistance profiles.

Market Consolidation and Pharma Strategies

Major pharmaceutical entities are divesting or licensing clarithromycin assets, favoring investments in newer antibiotics or exponentially profitable biologics. Pharmaceutical companies may seek to innovate or reposition clarithromycin in niche indications, such as rare infections or dermatological conditions.

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Impact of Global Health Initiatives

Global health authorities, including the WHO, emphasize combating antimicrobial resistance through stewardship and rational prescribing. Such policies are expected to curtail clarithromycin use further, especially in community settings. Incentives for the development of new antibiotics or alternative therapies are limited, compounding financial risks for innovators.

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Conclusion and Strategic Insights

The clarithromycin market is undergoing a paradigm shift shaped by antibiotic resistance, generics proliferation, and evolving prescribing habits. While historically a blockbuster, its revenue streams are under significant pressure. Companies must navigate a landscape increasingly characterized by regulatory restrictions and clinical resistance issues, emphasizing the importance of innovation and strategic repositioning.

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Key Takeaways

• Market contraction is imminent: Patent expirations and widespread resistance have reduced clarithromycin’s market size and margins.
• Resistance management is critical: Rising H. pylori and respiratory pathogen resistance levels threaten future utility, demanding alternative strategies.
• Generic competition dominates: Multiple generics have eroded pricing power, compelling originators to consider licensing or exit strategies.
• Growth opportunities are limited: Asia-Pacific markets and niche indications may offer prospects, but only with tailored approaches.
• Investment focus should shift: Stakeholders should prioritize R&D into novel antibiotics or combination therapies that can circumvent current resistance and regulatory barriers.

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FAQs

1. How does antibiotic resistance influence clarithromycin’s market viability?
Rising resistance rates reduce clarithromycin’s effectiveness, leading clinicians to favor alternative therapies. This trend diminishes sales and market share, particularly in regions with high resistance prevalence.

2. What are the primary factors driving generic clarithromycin sales?
Patent expirations and regulatory approvals facilitated widespread generics, resulting in significant price competition. Cost sensitivity among healthcare systems further amplifies generic market penetration.

3. Are there ongoing developments to improve clarithromycin formulations?
Limited innovation exists; most development focuses on resistance management rather than new formulations. The emphasis is on combination therapies and novel delivery methods to extend utility.

4. Which regions offer the most growth potential for clarithromycin?
Emerging markets in Asia-Pacific show growth potential due to increasing infectious disease burdens, though resistance and regulatory hurdles remain barriers.

5. What strategies can pharmaceutical companies deploy to sustain clarithromycin revenue?
Companies should consider repositioning in niche indications, licensing for specific markets, or investing in development of next-generation macrolides with improved resistance profiles.

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References

[1] FDA Orange Book – Patent and exclusivity data.
[2] World Health Organization. Antimicrobial Resistance Global Report. 2021.
[3] European Centre for Disease Prevention and Control. Antibiotic Resistance Trends. 2022.
[4] MarketResearch.com. Global Clarithromycin Market Forecasts. 2022.
[5] peer-reviewed literature on H. pylori resistance patterns.