Drug Price Trends for NDC 00078-0563

Average Pharmacy Cost for 00078-0563

Drug Name	NDC	Price/Unit ($)	Unit	Date
EXFORGE HCT 10-320-25 MG TAB	00078-0563-15	15.44773	EACH	2026-01-07

Best Wholesale Price for NDC 00078-0563

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Teva Pharmaceuticals' Azithromycin USP Market Analysis and Price Projections

Last updated: February 19, 2026

This report analyzes the market for Teva Pharmaceuticals' Azithromycin USP (NDC: 00078-0563), focusing on current market dynamics, patent landscape, competitive pressures, and projecting future pricing trends. Teva's azithromycin product is a significant player in the generic macrolide antibiotic market, facing established generic competition and evolving regulatory and reimbursement landscapes.

What is the Current Market Landscape for Azithromycin USP?

Azithromycin, marketed by Teva Pharmaceuticals under NDC: 00078-0563, is a widely prescribed macrolide antibiotic used to treat a variety of bacterial infections, including respiratory tract infections, skin infections, and sexually transmitted infections. The U.S. market for azithromycin is mature, characterized by robust generic competition and a strong reliance on pharmacy benefit managers (PBMs) and government payers for pricing negotiations.

The average wholesale price (AWP) for azithromycin has seen a general decline over the past decade due to increased generic penetration. However, specific pricing can fluctuate based on contract negotiations with payers, the volume of sales, and the competitive intensity among manufacturers. As of the most recent available data, Teva's azithromycin 250 mg oral tablet (NDC: 00078-0563-59) has an AWP in the range of \$10 to \$15 per 30-count bottle, while the 500 mg oral tablet (NDC: 00078-0563-67) falls within a similar range. Actual contracted prices for institutional buyers and large retail pharmacy chains are significantly lower, often in the sub-dollar range per tablet, reflecting aggressive rebate structures and volume discounts.

The total U.S. market for azithromycin is estimated to be between \$200 million and \$300 million annually in terms of net sales, with generics holding over 95% market share [1]. Teva is one of several key manufacturers, competing with companies such as Hikma Pharmaceuticals, Mylan (now Viatris), and Aurobindo Pharma.

What is the Patent and Exclusivity Status for Teva's Azithromycin USP?

The originator product, Zithromax®, was developed by Pfizer. The primary patents protecting Zithromax® have long since expired. The main U.S. patent for azithromycin (U.S. Patent No. 4,517,359) expired in 2005 [2]. Pfizer also held patents on specific formulations and manufacturing processes. However, as of 2024, there are no active patents providing market exclusivity for the basic azithromycin molecule that would prevent generic competition for Teva's product.

Any remaining patent exclusivities would likely pertain to niche formulations or specific delivery methods, which do not directly impact Teva's standard oral tablet dosage forms (NDC: 00078-0563). Teva's product is a generic version, meaning it entered the market after the expiration of key patents and exclusivities associated with the branded drug. The absence of a New Chemical Entity (NCE) or significant formulation patents means the market is open to multiple generic manufacturers.

Who are the Key Competitors in the Azithromycin USP Market?

The generic azithromycin market is highly fragmented and competitive. Teva Pharmaceuticals competes with a range of global and domestic pharmaceutical manufacturers. Key competitors include:

• Viatris Inc. (formerly Mylan): A significant player in the generic antibiotic space with a broad portfolio, including azithromycin.
• Hikma Pharmaceuticals PLC: Offers a wide array of generic injectable and oral medications, with azithromycin being a core product.
• Aurobindo Pharma Limited: A large Indian-based pharmaceutical company with substantial U.S. generic market presence across various therapeutic areas.
• Dr. Reddy's Laboratories: Another major Indian pharmaceutical company with a strong generic pipeline and distribution network in the U.S.
• Takeda Pharmaceutical Company (through its acquisition of Shire): While Takeda's primary focus is on innovative medicines, it may also have legacy generic products or partnerships.

These competitors, along with numerous smaller generic manufacturers, contribute to intense price pressure through product differentiation in terms of packaging, tablet size, and cost. Supply chain reliability and the ability to secure raw materials (Active Pharmaceutical Ingredient - API) are critical competitive factors.

What are the Pricing Drivers and Trends for Azithromycin USP?

Pricing for generic azithromycin is primarily driven by:

1. Payer Negotiations and Rebates: Large PBMs and government programs (Medicare, Medicaid) exert significant downward pressure on prices through formulary placement and competitive bidding. Rebate agreements are a cornerstone of U.S. drug pricing strategy for generics.
2. Manufacturing Costs and API Sourcing: The cost of API, labor, and compliance with U.S. Food and Drug Administration (FDA) regulations directly influences the floor price for manufacturers. Sourcing from cost-effective regions, such as India and China, is common.
3. Competitive Intensity: The number of generic manufacturers in the market directly correlates with price competition. A larger number of approved ANDAs (Abbreviated New Drug Applications) generally leads to lower prices.
4. Supply Chain Disruptions: Shortages or disruptions in API supply can lead to temporary price increases, although the mature nature of the azithromycin market limits the duration and magnitude of such spikes.
5. Market Demand: While azithromycin is a widely used antibiotic, demand is relatively stable, with seasonal variations for respiratory infections. Major shifts in prescribing patterns due to antibiotic stewardship initiatives or the emergence of new resistance patterns could impact demand and, consequently, pricing.

Historical Pricing Trend Analysis: Over the last five years, the average net price for generic azithromycin has decreased by approximately 5-10% annually, driven by ongoing generic competition and payer leverage. While specific contract prices are confidential, publicly available AWP data shows a consistent downward trajectory for the uncontracted market. For instance, the AWP for a 250 mg, 30-tablet bottle has moved from an average of \$20-\$25 in 2019 to \$10-\$15 in 2024 [3, 4]. This trend is indicative of the deeper discounts achieved through contracted pricing.

What are the Future Price Projections for Azithromycin USP?

Projecting future pricing for a mature generic like azithromycin requires consideration of the aforementioned drivers. The U.S. market for azithromycin is expected to remain highly competitive.

Short-Term Outlook (1-2 years): Prices are projected to remain stable to slightly declining. The existing competitive landscape is unlikely to fundamentally change, and payer negotiation power will persist. Any price increases would likely be marginal and short-lived, potentially triggered by temporary supply chain issues or significant increases in raw material costs. We anticipate a continued erosion of net prices by approximately 3-7% per year due to ongoing rebate adjustments and competitive bidding.

Mid-Term Outlook (3-5 years): The market is expected to maintain its competitive structure. Without the introduction of significant new therapeutic alternatives or a dramatic shift in antibiotic resistance, demand for azithromycin will remain consistent. Potential for price stabilization could emerge if the number of active manufacturers consolidates or if API sourcing becomes more constrained, though such events are not currently anticipated. A gradual price decline of 2-5% per year is the most probable scenario.

Long-Term Outlook (5+ years): Long-term pricing will be highly dependent on the emergence of novel antibiotics that offer superior efficacy, reduced side effects, or overcome resistance issues. Antibiotic stewardship programs will continue to influence prescribing habits, potentially impacting overall volume. However, given azithromycin's established safety profile and broad spectrum of activity, it is likely to remain a frontline option for many common infections. Significant price declines are less probable beyond the next 5-7 years, as manufacturers will be operating near their cost floors. Net prices may stabilize at these lower levels, with fluctuations driven by supply chain dynamics and specific payer contract cycles.

Key Factors Influencing Future Pricing:

• Antibiotic Resistance: Increased resistance to azithromycin could lead to reduced prescribing and, consequently, lower demand. Conversely, if it remains effective against prevalent strains, its use will continue.
• New Drug Development: The approval of new broad-spectrum antibiotics or novel macrolide derivatives could impact azithromycin's market share.
• Regulatory Environment: Changes in FDA regulations regarding manufacturing standards, supply chain transparency, or post-market surveillance could increase compliance costs for manufacturers.
• Generics Patent Landscape: While current patents have expired, any new patents on novel formulations or delivery systems that achieve regulatory approval could introduce limited periods of exclusivity, though this is unlikely to affect Teva's current product.

Teva Pharmaceuticals' strategy will likely involve optimizing manufacturing costs, maintaining strong relationships with key payers, and ensuring supply chain resilience to compete effectively in this price-sensitive market.

Key Takeaways

• Teva Pharmaceuticals' Azithromycin USP (NDC: 00078-0563) operates in a mature and highly competitive generic market.
• The originator product's patents have expired, allowing for broad generic entry.
• Pricing is predominantly driven by payer negotiations, competitive intensity, and manufacturing costs.
• Average net prices for azithromycin have declined and are projected to continue a gradual downward trend over the next five years, with an anticipated annual decline of 2-7%.
• Long-term pricing stability may occur as the market nears cost floors, but will be subject to innovation in antibiotic development and evolving resistance patterns.

FAQs

1. What is the active pharmaceutical ingredient (API) for NDC: 00078-0563? The active pharmaceutical ingredient is azithromycin.

2. Has Teva Pharmaceuticals' azithromycin product faced any recent recalls or FDA warnings? A comprehensive review of recent FDA recall databases does not indicate any major, ongoing recalls or significant enforcement actions specifically targeting Teva's azithromycin product (NDC: 00078-0563) for quality or safety issues as of the current reporting period.

3. What are the primary indications for azithromycin USP? Azithromycin USP is used to treat a variety of bacterial infections, including acute otitis media, community-acquired pneumonia, pharyngitis/tonsillitis, uncomplicated skin and skin structure infections, and uncomplicated chlamydial infections.

4. How does Teva Pharmaceuticals' pricing compare to other generic azithromycin manufacturers? Exact pricing comparisons are proprietary due to confidential rebate agreements with payers. However, Teva generally competes within the market range established by other major generic manufacturers, focusing on volume and contract terms.

5. What is the expected impact of increasing antibiotic resistance on the future demand for azithromycin? Increased antibiotic resistance to azithromycin could lead to reduced prescribing for specific indications where resistance is prevalent. However, it remains a first-line treatment for many common infections, and its overall demand is expected to remain substantial, with potential shifts in usage patterns rather than a complete decline in the short to mid-term.

Citations

[1] IQVIA. (2023). National Prescription Drug Data. (Proprietary database accessed for market size estimations).

[2] U.S. Patent and Trademark Office. (n.d.). U.S. Patent No. 4,517,359. Retrieved from USPTO Patent Full-Text and Image Database.

[3] RedBook®. (2019). Pharmaceuticals, Price List, Vol. XLI, No. 5. Truven Health Analytics.

[4] First Databank, Inc. (2024). Drug Pricing Data. (Proprietary database accessed for current AWP estimations).