ZMAX Drug Patent Profile

When do Zmax patents expire, and when can generic versions of Zmax launch?

Zmax is a drug marketed by Pf Prism Cv and is included in one NDA.

The generic ingredient in ZMAX is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zmax

A generic version of ZMAX was approved as azithromycin by PLIVA on November 14^th, 2005.

Summary for ZMAX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	74
Patent Applications:	3,137
Drug Prices:	Drug price information for ZMAX
What excipients (inactive ingredients) are in ZMAX?	ZMAX excipients list
DailyMed Link:	ZMAX at DailyMed

See drug prices for ZMAX

US Patents and Regulatory Information for ZMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	ZMAX	azithromycin	FOR SUSPENSION, EXTENDED RELEASE;ORAL	050797-001	Jun 10, 2005		DISCN	Yes	No

Expired US Patents for ZMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	ZMAX	azithromycin	FOR SUSPENSION, EXTENDED RELEASE;ORAL	050797-001	Jun 10, 2005	6,984,403
Pf Prism Cv	ZMAX	azithromycin	FOR SUSPENSION, EXTENDED RELEASE;ORAL	050797-001	Jun 10, 2005	7,887,844
Pf Prism Cv	ZMAX	azithromycin	FOR SUSPENSION, EXTENDED RELEASE;ORAL	050797-001	Jun 10, 2005	6,068,859
Pf Prism Cv	ZMAX	azithromycin	FOR SUSPENSION, EXTENDED RELEASE;ORAL	050797-001	Jun 10, 2005	6,268,489

International Patents for ZMAX

See the table below for patents covering ZMAX around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	71370
Canada	1310642	2-AMINO-5-HYDROXY-4-PYRIMIDONES (2-AMINO-5-HYDROXY-4-PYRIMIDONES)
Croatia	P950277	CONTROLLED-RELEASE DOSAGE FORMS OF AZITHROMYCIN
Finland	883285
Peru	4796	FORMAS DE DOSIFICACION DE LIBERACION CONTROLADA DE AZITROMICINA
South Korea	100906290
Yugoslavia	45075

Market Dynamics and Financial Trajectory for ZMAX (Azithromycin)

Introduction to ZMAX

ZMAX, the branded version of azithromycin developed by Pfizer, is one of the world's most popular and widely used antibiotics. Azithromycin, under the brand name Zithromax or ZMAX, has been a cornerstone in the treatment of various bacterial infections.

Market Size and Forecast

The azithromycin market, which includes ZMAX, is projected to experience significant growth. As of 2024, the azithromycin market was valued at $6.98 billion and is expected to reach $10.71 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.5% from 2024 to 2031[1].

Key Drivers of Market Growth

Several factors are driving the growth of the azithromycin market, including:

Increasing Prevalence of Bacterial Infections

The rising incidence of bacterial infections globally is a major driver. Azithromycin's efficacy and long-lasting presence in body tissues make it a preferred choice for treating a wide range of infections[1].

Growing Healthcare Expenditure

Increasing healthcare expenditure and the importance of azithromycin as a prophylactic agent are also significant factors. Pharmaceutical companies are investing heavily in research and development, further boosting market growth[1].

Emerging Markets

There is a substantial and growing demand for azithromycin in emerging markets such as China, India, Brazil, and Mexico. This demand is driven by the increasing incidence of infectious diseases, rising incomes, and improving healthcare infrastructure[1].

Market Segmentation

The azithromycin market is segmented based on type, distribution channel, and geography.

By Type

The market is segmented into oral, injectable, and ophthalmic forms. The oral segment dominates the market and is expected to continue its dominance during the forecast period[1].

By Distribution Channel

Hospital pharmacies hold the highest market share, followed by retail pharmacies and online pharmacies. Hospital pharmacies are expected to continue their strong market growth[1].

By Geography

North America and Europe are the dominant regions, with significant market shares. However, the Asia Pacific region is also growing rapidly due to increasing demand in countries like China, India, and Japan[1].

Financial Performance and Historical Context

Peak Sales and Patent Expiry

Zithromax, Pfizer's branded version of azithromycin, was one of the best-selling branded antibiotics globally, with peak sales of $2 billion in 2005. However, sales declined after the loss of patent protection in 2006, leading to increased competition from generic versions[4].

Impact on Licensing Partners

The licensing agreement between Pfizer and Pliva, a Croatian pharmaceutical company, was highly beneficial for Pliva. It enabled Pliva to expand significantly in Europe and the United States, eventually becoming one of the largest pharmaceutical companies in Central and Eastern Europe[4].

Challenges and Restraints

Regulatory Approvals and Disapprovals

While azithromycin is approved for various conditions such as acute bacterial urinary tract infections, sinusitis, and skin infections, there have been regulatory disapprovals due to risk issues. For instance, its use is cautioned in patients with known prolongation of the QT interval or those receiving certain antiarrhythmic agents[2][5].

Adverse Reactions and Drug Resistance

The use of azithromycin is associated with several adverse reactions, including gastrointestinal disturbances, cardiovascular risks, and the potential for drug-resistant bacteria. These factors can restrain market growth and necessitate careful prescribing practices[2][5].

Competitive Landscape

The azithromycin market is highly competitive, with several key players including CSPC Ouyi Pharmaceutical, Aurobindo Pharma, and Pfizer. Companies are investing in research and development to maintain market share and explore new treatment options[1].

Future Outlook

Despite the challenges, the azithromycin market, including ZMAX, is poised for continued growth. The increasing prevalence of bacterial infections, growing healthcare expenditure, and expanding demand in emerging markets will drive this growth.

Key Takeaways

• The azithromycin market is projected to grow from $6.98 billion in 2024 to $10.71 billion by 2031.
• Key drivers include the increasing prevalence of bacterial infections, growing healthcare expenditure, and demand in emerging markets.
• The oral segment dominates the market, and hospital pharmacies are the primary distribution channel.
• Regulatory approvals and disapprovals, along with adverse reactions and drug resistance, are significant challenges.
• The competitive landscape is marked by significant investments in research and development.

Frequently Asked Questions (FAQs)

Q: What is the projected growth rate of the azithromycin market from 2024 to 2031? A: The azithromycin market is expected to grow at a CAGR of 3.5% from 2024 to 2031[1].

Q: Which segment dominates the azithromycin market by type? A: The oral segment dominates the azithromycin market and is expected to continue its dominance during the forecast period[1].

Q: What are the primary distribution channels for azithromycin? A: Hospital pharmacies hold the highest market share, followed by retail pharmacies and online pharmacies[1].

Q: Which regions are expected to dominate the global azithromycin market? A: North America and Europe are the dominant regions, but the Asia Pacific region is also growing rapidly[1].

Q: What are some of the significant challenges facing the azithromycin market? A: Regulatory disapprovals, adverse reactions, and the potential for drug-resistant bacteria are significant challenges[2][5].

Sources:

1. Verified Market Research - Azithromycin Market Size & Forecast
2. FDA - Zmax Label
3. Morgan Stanley - Scaling Up the Impact of Obesity Drugs
4. WIPO - Azithromycin: A world best-selling Antibiotic
5. FDA - Zmax (Azithromycin) Label