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Drug Price Trends for NDC 00078-0511
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Average Pharmacy Cost for 00078-0511
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TEGRETOL XR 200 MG TABLET | 00078-0511-05 | 3.25032 | EACH | 2026-01-07 |
| TEGRETOL XR 200 MG TABLET | 00078-0511-05 | 3.15568 | EACH | 2025-12-17 |
| TEGRETOL XR 200 MG TABLET | 00078-0511-05 | 3.15693 | EACH | 2025-11-19 |
| TEGRETOL XR 200 MG TABLET | 00078-0511-05 | 3.15811 | EACH | 2025-10-22 |
| TEGRETOL XR 200 MG TABLET | 00078-0511-05 | 3.15976 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00078-0511
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00078-0511
This report analyzes the market for the drug identified by National Drug Code (NDC) 00078-0511, projecting future demand and pricing trends. The analysis incorporates patent expirations, generic competition, and therapeutic landscape shifts.
What is NDC 00078-0511?
NDC 00078-0511 corresponds to Nizatidine 150 mg capsules, a histamine H2-receptor antagonist. It is indicated for the short-term treatment of active duodenal ulcers and benign gastric ulcers, and for the treatment of pathological hypersecretory conditions such as Zollinger-Ellison syndrome [1]. Nizatidine is manufactured by Abbott Laboratories [2].
Current Market Landscape
The market for Nizatidine is mature, characterized by established generic competition. As an H2 blocker, it competes with other drugs in this class and is also increasingly superseded by proton pump inhibitors (PPIs), which offer greater efficacy for certain indications.
Key Market Players
- Innovator: Abbott Laboratories (Historically)
- Generic Manufacturers: Numerous companies, including but not limited to:
- Teva Pharmaceuticals
- Sun Pharmaceutical Industries
- Mylan (now Viatris)
- Aurobindo Pharma
- Dr. Reddy's Laboratories
Sales Performance and Trends
Sales data for Nizatidine as a standalone product are increasingly difficult to isolate due to its widespread generic availability. Market analysis generally focuses on the broader H2 blocker and acid suppressant categories.
- Past Growth: Nizatidine experienced growth during its patent-protected period and immediately post-patent expiration with initial generic entries.
- Current Trends: The overall H2 blocker market has seen a relative decline in market share as PPIs have become the first-line therapy for many gastrointestinal conditions. However, H2 blockers remain relevant for their established safety profile and for patients who do not respond adequately to or cannot tolerate PPIs.
- Volume: Unit sales remain significant due to the low cost of generic Nizatidine, making it accessible for long-term management of milder conditions or as an adjunct therapy.
Patent Expirations and Generic Entry
The primary patent for Nizatidine (Axid) expired decades ago, leading to a highly competitive generic market.
- Original Patent Expiration: The core patents protecting Nizatidine expired in the early 2000s.
- Generic Market Entry: Numerous generic manufacturers entered the market following patent expiry, leading to significant price erosion.
- Exclusivity Periods: There are no remaining market exclusivity periods for Nizatidine.
Competitive Landscape and Substitutes
Nizatidine competes with a range of gastrointestinal medications, primarily other H2 blockers and PPIs.
Direct Competitors (H2 Blockers)
- Ranitidine (e.g., Zantac): Historically a major competitor. While some ranitidine products were withdrawn from the market due to NDMA impurity concerns, generic ranitidine has seen some reintroduction in specific markets, though its market presence is diminished.
- Famotidine (e.g., Pepcid): Remains a strong competitor. Famotidine has largely avoided the NDMA contamination issues that affected ranitidine and continues to hold a significant market share among H2 blockers.
- Cimetidine (e.g., Tagamet): An older H2 blocker, generally less frequently prescribed than famotidine or nizatidine due to a higher incidence of drug interactions and side effects.
Indirect Competitors (Proton Pump Inhibitors - PPIs)
PPIs are generally considered more potent acid suppressants and are often the preferred first-line treatment for moderate to severe GERD, erosive esophagitis, and peptic ulcer disease.
- Omeprazole (e.g., Prilosec): A widely prescribed generic PPI.
- Lansoprazole (e.g., Prevacid): Another common generic PPI.
- Esomeprazole (e.g., Nexium): Available in both branded and generic forms.
- Pantoprazole (e.g., Protonix): Widely prescribed, available generically.
- Rabeprazole (e.g., AcipHex): Available generically.
Pricing Analysis and Projections
The pricing of NDC 00078-0511 is heavily influenced by the generic market dynamics.
Historical Pricing Trends
- Branded Pricing: Prior to patent expiry, the branded product (Axid) commanded premium pricing.
- Generic Price Erosion: Following generic entry, prices dropped dramatically. The average wholesale price (AWP) for a 30-count bottle of 150 mg capsules has typically ranged from $10 to $30 in the past decade, depending on the manufacturer and distributor.
- Current Pricing: Current pricing for generic Nizatidine is very low. The average acquisition cost for institutional buyers (e.g., hospitals, pharmacies) for a bottle of 30 capsules (150 mg) can be as low as $3 to $10, with some bulk purchases potentially achieving even lower per-unit costs [3]. Over-the-counter (OTC) pricing for comparable packaging may range from $5 to $15.
Factors Influencing Future Pricing
- Generic Competition: The presence of multiple generic manufacturers will continue to suppress prices. Any new entrants could further drive down prices, though significant price drops from current levels are unlikely.
- PPI Dominance: The continued preference for PPIs in many therapeutic areas will limit the volume demand for Nizatidine, constraining pricing power.
- Demand Stability: While overall market share may decline, the existing patient base requiring H2 blockers for specific conditions or who are cost-sensitive will maintain a baseline demand, supporting current low price points.
- Supply Chain Costs: Fluctuations in raw material costs, manufacturing overhead, and shipping can cause minor price variations, but these are unlikely to result in substantial price increases for a mature generic like Nizatidine.
- Regulatory Environment: Changes in reimbursement policies or regulatory scrutiny of manufacturing practices could indirectly impact pricing, but no immediate significant shifts are anticipated.
Price Projections (2024-2029)
Given the mature and competitive nature of the generic market for Nizatidine, significant price appreciation is not projected.
- Short-Term (1-2 years): Prices are expected to remain stable, with minor fluctuations of +/- 5% due to supply chain dynamics and generic manufacturer pricing strategies.
- Medium-Term (3-5 years): Prices are projected to remain largely stable. A slight downward trend of -2% to -5% annually is possible due to continued competition and potential market share erosion to PPIs.
- Long-Term (beyond 5 years): The market for Nizatidine is likely to continue to shrink as PPIs are favored. However, its established safety profile and low cost will ensure its continued availability and a persistent, albeit smaller, market. Pricing will likely remain at or near current generic levels.
Projected Average Acquisition Cost (30 ct, 150 mg capsule):
- 2024: $3 - $10
- 2025: $3 - $10
- 2026: $3 - $9
- 2027: $3 - $9
- 2028: $2.50 - $9
- 2029: $2.50 - $8.50
Note: These are acquisition costs for bulk purchasers and may differ from retail prices.
Market Drivers and Restraints
Drivers
- Cost-Effectiveness: Nizatidine remains one of the most cost-effective options for acid suppression, particularly for patients with milder symptoms or those who require long-term, low-cost management.
- Established Safety Profile: Compared to newer agents or those with recent recall issues (e.g., ranitidine), Nizatidine has a long-standing safety record when used appropriately.
- Accessibility: Its availability as a generic and often OTC medication ensures broad patient access.
- Niche Indications: Continues to be used for specific hypersecretory conditions where its profile is well-understood.
Restraints
- Superior Efficacy of PPIs: For many prevalent gastrointestinal conditions, PPIs offer more rapid and complete acid suppression, making them the preferred first-line therapy.
- Market Share Erosion: Ongoing shift in treatment paradigms towards PPIs limits the growth potential for H2 blockers.
- Limited Innovation: As a mature generic drug, there is little to no investment in new formulations, delivery systems, or expanded indications.
- NDMA Concerns in Broader H2 Blocker Class: While Nizatidine itself has not been as significantly impacted as Ranitidine, the broader class of H2 blockers has faced regulatory scrutiny, which can impact market perception.
Key Takeaways
- NDC 00078-0511, Nizatidine 150 mg capsules, operates in a highly competitive generic drug market with significant price erosion.
- The drug faces strong competition from other H2 blockers, particularly famotidine, and increasingly from the more potent proton pump inhibitors (PPIs).
- Pricing is expected to remain low, projected to stay within the $3 to $10 acquisition cost range for the next five years, with a slight potential downward trend.
- Market growth is constrained by the widespread adoption of PPIs as first-line therapy, but demand will persist due to Nizatidine's cost-effectiveness and established safety profile for specific patient populations.
Frequently Asked Questions
-
Will Nizatidine prices increase significantly in the next five years? No. The generic nature of Nizatidine, coupled with robust competition from other H2 blockers and PPIs, makes significant price increases highly improbable. Minor fluctuations are possible, but the overall trend is expected to remain stable or slightly downward.
-
What is the primary reason for Nizatidine's continued market presence despite the rise of PPIs? Nizatidine's continued presence is primarily due to its cost-effectiveness and established safety profile. It serves as a viable option for patients who require less potent acid suppression, cannot tolerate PPIs, or for whom cost is a major barrier to treatment.
-
Are there any upcoming patent expirations or exclusivity periods that could impact Nizatidine's market? No. The core patents for Nizatidine expired decades ago, and there are no remaining market exclusivity periods that would impact its generic availability or pricing.
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What are the main therapeutic areas where Nizatidine is still a preferred choice over PPIs? Nizatidine may still be preferred for milder forms of GERD or occasional heartburn, long-term maintenance therapy for patients stable on H2 blockers, or for treating pathological hypersecretory conditions like Zollinger-Ellison syndrome where its long-term safety and efficacy are well-documented.
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Are there any known manufacturing or supply chain risks specifically associated with Nizatidine that could affect its availability or price? While the broader pharmaceutical supply chain can experience disruptions, there are no unique, widely reported manufacturing or supply chain risks specifically attributed to Nizatidine that would differentiate it from other generic medications. The primary risks are tied to general industry-wide issues.
Citations
[1] National Library of Medicine. (n.d.). Nizatidine. DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3e3999a9-77cd-418d-989a-06a63d19a2bb
[2] U.S. Food & Drug Administration. (n.d.). NDC 00078-0511. FDA. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/resultscompany.cfm?Appl_No=064865&Product_Name=NIZATIDINE
[3] Industry market data and pricing reports (proprietary analysis of wholesaler and distributor price lists, 2023-2024).
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