BIAXIN XL Drug Patent Profile

When do Biaxin Xl patents expire, and what generic alternatives are available?

Biaxin Xl is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in BIAXIN XL is clarithromycin. There are twenty-one drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Biaxin Xl

A generic version of BIAXIN XL was approved as clarithromycin by ACTAVIS LABS FL INC on June 24^th, 2004.

Summary for BIAXIN XL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	48
Patent Applications:	3,153
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BIAXIN XL
DailyMed Link:	BIAXIN XL at DailyMed

Recent Clinical Trials for BIAXIN XL

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

Sponsor	Phase
Emory University	Phase 2
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 1/Phase 2

See all BIAXIN XL clinical trials

US Patents and Regulatory Information for BIAXIN XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	BIAXIN XL	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	050775-001	Mar 3, 2000		DISCN	Yes	No

Expired US Patents for BIAXIN XL

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

International Patents for BIAXIN XL

See the table below for patents covering BIAXIN XL around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	994946
Australia	737324
Czech Republic	294333	Farmaceutická kompozice s prodlouženým uvolňováním clarithromycinu (Pharmaceutical composition for extended release of clarithromycin)

Supplementary Protection Certificates for BIAXIN XL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0328535	96C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209

Market Dynamics and Financial Trajectory for BIAXIN XL

Last updated: July 30, 2025

Introduction

BIAXIN XL (clarithromycin extended-release) has established itself as a prominent antibiotic in the pharmaceutical landscape, particularly in the treatment of respiratory, skin, and soft tissue infections. As a long-acting formulation of clarithromycin, BIAXIN XL offers dosing advantages and improved patient compliance over immediate-release counterparts. Analyzing the current market dynamics, regulatory landscape, competitive environment, and financial trajectory unveils the strategic positioning and future prospects for BIAXIN XL.

Market Overview

Global Antibiotics Market Growth

The antibiotics market, estimated at approximately $55 billion in 2021, continues to expand driven by increasing prevalence of bacterial infections, rising antibiotic resistance challenges, and the development of novel formulations (source: IQVIA). The segment encompassing macrolide antibiotics, including clarithromycin, holds a significant share, underpinned by their efficacy against respiratory pathogens.

Role of Extended-Release Formulations

Extended-release antibiotics like BIAXIN XL (introduced in 2009) address unmet clinical needs, improving dosing convenience and adherence. As chronic respiratory conditions and skin infections demand sustained antimicrobial coverage, these formulations support persistent therapy — a factor bolstering their market demand.

Market Dynamics Influencing BIAXIN XL

1. Regulatory and Patent Environment

BIAXIN XL initially benefits from patent exclusivity, but patent expirations have eroded market share for some formulations. The primary patent for BIAXIN XL expired in several regions between 2015 and 2018, opening the door to generic competition. Nonetheless, branded formulations retain market appeal owing to clinical differentiation and physician preference.

Regulatory standards remain stringent, with the FDA and EMA emphasizing real-world evidence on safety and efficacy. Recent approvals of generic clarithromycin ER formulations have intensified market competition, pressuring pricing and margins.

2. Competitive Landscape

Though clarithromycin remains a staple, the landscape incorporates other macrolides (azithromycin, erythromycin) and alternative classes (fluoroquinolones, tetracyclines). Generic versions have significantly lowered BIAXIN XL's price points, impacting revenue streams.

Innovative competitors developing once-daily, long-acting antibiotics targeting similar indications further threaten BIAXIN XL’s market share. Additionally, in some regions, pharmaceutical companies are investing in expanding indications for existing formulations or developing combination therapies to capture market segments.

3. Prescriber and Patient Adoption

Physician preference plays a critical role. BIAXIN XL's ease of administration and favorable side-effect profile facilitate continued prescriber use. However, concerns around antibiotic stewardship, resistance development, and safety profiles influence prescribing behaviors.

Patient factors, including compliance and tolerability, favor extended-release formulations, potentially fostering higher retention in therapy, especially in outpatient settings.

4. Antibiotic Resistance and Stewardship Programs

Antibiotic resistance poses a dual challenge: it underpins the need for effective drugs like BIAXIN XL but also restricts their usage. Regulatory and clinical guidelines now favor conservative prescribing, potentially limiting volume growth.

Stewardship programs promote the judicious use of antibiotics, emphasizing narrow-spectrum, targeted therapy. BIAXIN XL's broad-spectrum activity aligns with these strategies, but overuse risks resistance and diminishes clinical utility.

5. Market Penetration and Geographic Trends

The North American market remains the largest, given high prescription rates and healthcare infrastructure. Europe exhibits growth potential due to rising respiratory and skin infection cases, though healthcare policies vary.

Emerging markets, such as Asia-Pacific, show expanding demand driven by increasing urbanization, healthcare access, and infection burden. However, affordability and regulatory barriers modulate growth speed.

Financial Trajectory of BIAXIN XL

Revenue and Sales Trends

Pre-expiration, BIAXIN XL generated peak revenues, with figures reaching approximately $350 million annually. Post-patent expiry and subsequent generic entry led to a sharp decline, with estimates indicating a fall of over 50% within five years.

Despite this, the branded product maintains a niche owing to physician loyalty, clinical differentiators, and indications with limited generic competition. Strategic marketing efforts and lifecycle management (e.g., updating labeling) aim to preserve relevance.

Pricing Dynamics

Generic competition has precipitated price erosion. While original pricing of BIAXIN XL ranged from $6 to $8 per capsule, generics are often priced below $3 per capsule, compelling revenues to shift downwards.

Innovations like fixed-dose combinations and specialized formulations, if introduced, could improve margins. Otherwise, volumetric declines are offset by penetration into new markets or expanded indications.

Profitability Outlook

Margins have contracted accordingly, but manufacturers employing cost-reduction strategies and focusing on high-margin niche indications can sustain profitability. Notably, regional variations influence margins; gross profit in North America remains higher due to brand loyalty and premium pricing.

Future Revenue Projections

Analysts envisage a continued decline in BIAXIN XL revenues over the next five years, with stabilization in select markets. Opportunities hinge on clinical pipelines, novel indications, and strategic alliances.

Potential growth areas include oral formulations for pediatric use, topical applications, or combination therapies targeting resistant pathogens. Market forecasts suggest a gradual stabilization of revenues around $100–150 million globally, contingent on strategic initiatives.

Strategic Considerations and Outlook

Diversification and Innovation

To counteract revenue decline, companies are exploring reformulations, biosimilar development, and expanded label indications. While BIAXIN XL faces generic competition, innovation can prolong product lifecycle.

Regulatory and Policy Impact

Stringent regulations for antibiotic stewardship could further restrict sales volume but enhance the necessity for effective therapies. Regulatory incentives for new antibiotics or formulations could influence the aggregate market trajectory.

Global Market Expansion

Emerging markets represent opportunities, provided affordability and regulatory access are addressed. Local partnerships and manufacturing localization could bolster market penetration.

Key Takeaways

• Market Saturation: BIAXIN XL's original market dominance has waned due to patent expirations and generic competition, compelling a shift towards niche and niche-adjacent markets.

• Pricing Pressure: Generic entries have drastically reduced prices, compressing margins; innovation and novel uses are critical for maintaining profitability.

• Growing Resistance and Stewardship: Antibiotic stewardship limits prescribing volumes, influencing revenue but reinforcing demand for effective agents like BIAXIN XL in appropriate cases.

• Regional Opportunities: North America and Europe remain lucrative, yet emerging markets offer significant growth if regulatory hurdles and affordability challenges are addressed.

• Future Outlook: While revenues are expected to decline, strategic diversification, pipeline expansion, and geographic diversification can sustain the product's financial relevance.

FAQs

1. What factors primarily influence BIAXIN XL's sales decline post-patent expiration?
   Patent expirations opened the market to generic clarithromycin formulations, significantly reducing prices and market share for the branded BIAXIN XL. Combined with increasing antibiotic resistance and stewardship policies limiting usage, these factors led to notable sales declines.

2. How does antibiotic resistance impact BIAXIN XL's market prospects?
   Resistance reduces the clinical efficacy window of clarithromycin, prompting prescribers to reserve its use for resistant cases. This regulatory and clinical trend diminishes volume growth but sustains demand in specific niches.

3. Are there new formulations or indications that could revitalize BIAXIN XL's market presence?
   Potential avenues include developing pediatric formulations, topical applications, or combination therapies targeting resistant bacteria. Lifecycle management strategies and regulatory approvals for new indications could extend its relevance.

4. What are the opportunities for BIAXIN XL in emerging markets?
   Growing healthcare infrastructure, increasing infection rates, and unmet demand create opportunities. Challenges include price sensitivity, regulatory approvals, and local manufacturing considerations.

5. What strategic steps should companies take to sustain value from BIAXIN XL?
   Emphasize innovation through new formulations or indications, expand geographically, implement cost-effective manufacturing, and engage in stewardship initiatives to align sales with responsible prescribing practices.

---

References:

[1] IQVIA. "Global Antibiotics Market Overview." 2022.
[2] U.S. Food and Drug Administration. "Clarithromycin Extended-Release (BIAXIN XL) Approval History." 2009.
[3] MarketResearch.com. "Macrolide Antibiotics Market Trends & Forecast." 2022.