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-eight 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:	86
Clinical Trials:	48
Patent Applications:	3,847
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
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2
Emory University	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
Hong Kong	1027023
Czech Republic	347199
Israel	223035
Canada	2285266	FORMULATIONS A LIBERATION PROLONGEE DE DERIVES D'ERYTHROMYCINE (EXTENDED RELEASE FORMULATIONS OF ERYTHROMYCIN DERIVATIVES)
Japan	2009137988	SUSTAINED RELEASE FORMULATION OF ERYTHROMYCIN DERIVATIVE
European Patent Office	1340495	Comprimé de clarithromycin à libération prolongée (Extended release tablet of clarithromycin)
Israel	149033

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

BIAXIN XL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BIAXIN XL

Introduction to BIAXIN XL

BIAXIN XL, also known as clarithromycin extended-release tablets, is a semi-synthetic macrolide antibiotic used to treat various bacterial infections. It is available in several forms, including immediate-release tablets, extended-release tablets, and granules for oral suspension[1][4].

Market Size and Growth

The clarithromycin tablets market, which includes BIAXIN XL, is experiencing significant growth driven by several key factors. As of 2024, the market size was valued at USD 1.9 billion and is projected to reach USD 2.9 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.9% from 2024 to 2031[2].

Drivers of Market Growth

Increasing Incidence of Respiratory Infections

The growing incidence of respiratory infections such as pneumonia and bronchitis is a major driver of the market. These infections often require effective antibiotic treatments, and clarithromycin, including its extended-release form, is a preferred option[2].

Concerns Over Antibiotic Resistance

The rising concern over antibiotic resistance has led to an increased demand for effective treatment options for resistant bacterial strains. BIAXIN XL, with its extended-release formulation, offers enhanced efficacy and patient compliance, making it a valuable option in this context[2].

Innovations in Drug Formulations

Innovations in drug formulations, particularly the development of extended-release versions like BIAXIN XL, have improved the efficacy and patient compliance of clarithromycin. These advancements have contributed significantly to the market's growth[2].

Global Healthcare Spending

Increased healthcare spending globally has also supported the adoption of advanced antibiotics like BIAXIN XL. This trend is expected to continue, driving the market forward[2].

Financial Trajectory

Cost-Effectiveness

Studies have shown that BIAXIN XL is cost-effective compared to its immediate-release counterpart. Decision-analysis modeling indicates that the extended-release formulation results in lower total costs, primarily due to greater adherence and fewer discontinuations due to adverse events. For example, total costs with extended-release clarithromycin were $32 (16%) less compared to immediate-release for treating lower respiratory tract infections (LRTI)[3].

Revenue Forecast

The revenue forecast for the clarithromycin tablets market, including BIAXIN XL, is robust. The market is expected to grow from USD 1.9 billion in 2024 to USD 2.9 billion by 2031. This growth is driven by the increasing demand for effective antibiotic treatments and the advantages offered by extended-release formulations[2].

Market Segmentation

Clinical Applications

BIAXIN XL is indicated for the treatment of various infections, including uncomplicated skin and skin structure infections, lower respiratory tract infections, and mycobacterial infections. Its use in combination with other medicines for treating duodenal ulcers and Helicobacter pylori infections also contributes to its market presence[1][4].

Geographic Distribution

The market for clarithromycin tablets, including BIAXIN XL, is distributed across various regions. The global nature of the market ensures that the drug is accessible in different parts of the world, catering to diverse healthcare needs[2].

Competitive Landscape

The clarithromycin market, including BIAXIN XL, is competitive with several key players involved in the production and distribution of the drug. The competitive landscape is influenced by factors such as product innovation, pricing strategies, and regulatory approvals[2].

Patient Compliance and Adherence

One of the significant advantages of BIAXIN XL is its once-daily dosing regimen, which enhances patient compliance and adherence. This is particularly important for antibiotics, where consistent dosing is crucial for effective treatment and preventing the development of drug-resistant bacteria[1][3].

Side Effects and Safety Profile

While BIAXIN XL is generally well-tolerated, it can cause several side effects, including diarrhea, abnormal taste, nausea, and others. However, the extended-release formulation tends to have a better safety profile compared to the immediate-release form, with fewer discontinuations due to adverse events[1][5].

Conclusion

The market dynamics and financial trajectory for BIAXIN XL are positive, driven by increasing demand for effective antibiotic treatments, innovations in drug formulations, and global healthcare spending. The cost-effectiveness, enhanced patient compliance, and robust revenue forecast all contribute to the drug's strong market position.

Key Takeaways

• The clarithromycin tablets market, including BIAXIN XL, is projected to grow from USD 1.9 billion in 2024 to USD 2.9 billion by 2031.
• The market is driven by the increasing incidence of respiratory infections, concerns over antibiotic resistance, and innovations in drug formulations.
• BIAXIN XL is cost-effective and enhances patient compliance due to its once-daily dosing regimen.
• The drug is indicated for various infections and is part of a competitive market landscape.
• Despite potential side effects, the extended-release formulation of BIAXIN XL has a favorable safety profile.

FAQs

Q: What is BIAXIN XL used for?

A: BIAXIN XL is used to treat various bacterial infections, including lower respiratory tract infections, uncomplicated skin and skin structure infections, and mycobacterial infections.

Q: How does the extended-release formulation of BIAXIN XL benefit patients?

A: The extended-release formulation of BIAXIN XL enhances patient compliance due to its once-daily dosing regimen and has been shown to be cost-effective with fewer discontinuations due to adverse events.

Q: What are the common side effects of BIAXIN XL?

A: Common side effects include diarrhea, abnormal taste, nausea, and others. However, the extended-release formulation tends to have a better safety profile compared to the immediate-release form.

Q: How is the market for clarithromycin tablets expected to grow?

A: The market is expected to grow from USD 1.9 billion in 2024 to USD 2.9 billion by 2031, at a CAGR of 6.9%.

Q: Why is BIAXIN XL preferred over immediate-release clarithromycin?

A: BIAXIN XL is preferred due to its enhanced efficacy, better patient compliance, and cost-effectiveness compared to the immediate-release form.

Sources

1. BIAXIN® Filmtab® (clarithromycin tablets, USP) - accessdata.fda.gov
2. Clarithromycin Tablets Market Size, Share, Trends & Forecast - Verified Market Research
3. Costs and outcomes of extended-release vs. immediate-release clarithromycin - PubMed
4. PRODUCT MONOGRAPH PrBIAXIN BID® PrBIAXIN® XL PrBIAXIN® - Health Canada
5. Clarithromycin (oral route) - Mayo Clinic