Drug Price Trends for NDC 00143-9638

Average Pharmacy Cost for 00143-9638

Drug Name	NDC	Price/Unit ($)	Unit	Date
SUMATRIPTAN 6 MG/0.5 ML VIAL	00143-9638-01	15.00000	ML	2026-03-18
SUMATRIPTAN 6 MG/0.5 ML VIAL	00143-9638-05	15.08010	ML	2026-03-18
SUMATRIPTAN 6 MG/0.5 ML VIAL	00143-9638-05	14.57232	ML	2026-02-18
SUMATRIPTAN 6 MG/0.5 ML VIAL	00143-9638-01	15.00000	ML	2026-02-18

Best Wholesale Price for NDC 00143-9638

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
SUMATRIPTAN SUCCINATE 6MG/0.5ML INJ,VIL,0.5ML	Golden State Medical Supply, Inc.	00143-9638-05	5X0.5ML	51.01		2023-06-15 - 2028-06-14	FSS
SUMATRIPTAN SUCCINATE 6MG/0.5ML INJ,VIL,0.5ML	Golden State Medical Supply, Inc.	00143-9638-05	5X0.5ML	57.67		2023-06-23 - 2028-06-14	FSS

Nexium (Esomeprazole Magnesium) Patent Expirations and Market Landscape

Last updated: February 18, 2026

This analysis details the patent expiration timeline for Nexium (esomeprazole magnesium) and its impact on market pricing and generic competition. Nexium, an AstraZeneca proton pump inhibitor (PPI), faces significant generic market penetration following key patent expiries.

What is the Patent Expiration Status of Nexium?

The primary patent protecting Nexium, U.S. Patent No. 6,011,037, expired on April 21, 2014 [1]. This patent covered the compound esomeprazole and its use in treating acid-related disorders. Supplementary patents, such as those related to specific formulations or manufacturing processes, have also expired or will expire shortly, further opening the market to generic alternatives. For instance, U.S. Patent No. 6,800,707, concerning an improved method of producing esomeprazole, expired on August 4, 2018 [2]. The expiry of these core patents has led to widespread generic availability.

Who are the Key Generic Competitors for Nexium?

Following the expiration of Nexium's core patents, numerous pharmaceutical companies have entered the market with generic versions of esomeprazole magnesium. Key players include Teva Pharmaceuticals, Sandoz (a division of Novartis), Mylan (now Viatris), and Aurobindo Pharma [3, 4]. These companies have introduced a range of bioequivalent products, intensifying competition and driving down prices. The U.S. Food and Drug Administration (FDA) has approved multiple Abbreviated New Drug Applications (ANDAs) for esomeprazole magnesium, signifying the establishment of generic equivalents [5].

How Have Patent Expirations Affected Nexium's Market Price?

The introduction of generic esomeprazole magnesium has resulted in a substantial decline in the average selling price (ASP) of Nexium and its generic counterparts. Prior to patent expiry, Nexium commanded a premium price. Post-expiry, the competitive landscape dictates a significantly lower price point. Data from various sources, including Centers for Medicare & Medicaid Services (CMS) drug pricing data, demonstrate this trend. For example, the average manufacturer price (AMP) for esomeprazole magnesium oral suspension, 10 mg/5 mL, has decreased from approximately \$250-\$300 per bottle in the pre-generic era to under \$50 per bottle in recent years [6]. Similarly, the ASP for esomeprazole magnesium delayed-release capsules, 20 mg, has fallen from an average of over \$10 per capsule to less than \$1 per capsule [6]. This price erosion is a direct consequence of generic competition, with multiple manufacturers vying for market share.

What is the Current Market Size and Projected Growth for Esomeprazole Magnesium?

The market for esomeprazole magnesium, encompassing both branded Nexium (though its market share has significantly diminished) and its generic versions, remains substantial. The prevalence of gastroesophageal reflux disease (GERD) and other acid-related disorders contributes to consistent demand [7]. Market research reports indicate that the global esomeprazole market was valued at approximately \$4.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 3-5% through 2028 [8]. This growth is primarily driven by the increasing prevalence of GERD, aging populations, and the continued accessibility and affordability of generic esomeprazole [8]. While the branded Nexium's sales have declined, the overall esomeprazole magnesium market, dominated by generics, continues to generate significant revenue.

Table 1: Esomeprazole Magnesium Market Data Overview

Metric	Value (Approximate)	Source Year	Notes
Global Market Value	\$4.5 billion	2022	Encompasses branded and generic forms.
Projected CAGR (2023-2028)	3-5%	2023	Driven by GERD prevalence and generic access.
Price Decline (Post-Patent)	>90%	2015-Present	For common capsule strengths.

Source: Market research reports and CMS drug pricing data analysis.

What is the Impact of Biosimilar Competition on Nexium?

Nexium is a small molecule drug, not a biologic. Therefore, the concept of biosimilars, which applies to biologic drugs, is not applicable to esomeprazole magnesium. The competition in the esomeprazole magnesium market comes from chemically synthesized generic drugs, not biosimilars [9]. Generic drugs are considered therapeutically equivalent to their brand-name counterparts once their patents expire and the FDA approves their generic versions.

What are the Regulatory Considerations for Generic Esomeprazole Magnesium?

Generic esomeprazole magnesium products must meet stringent regulatory requirements set by the FDA. This includes demonstrating pharmaceutical equivalence (same active ingredient, dosage form, strength, and route of administration) and bioequivalence (demonstrating that the rate and extent of absorption of the active ingredient are not significantly different from the reference listed drug) [10]. Manufacturers must submit an ANDA to the FDA, which includes data supporting these claims, along with information on manufacturing processes, quality control, and labeling. Once approved, generic manufacturers must adhere to Good Manufacturing Practices (GMP) and post-market surveillance requirements. The FDA's Orange Book lists approved drug products with therapeutic equivalence evaluations, confirming the availability of bioequivalent generic esomeprazole magnesium [5].

What is the Reimbursement Landscape for Esomeprazole Magnesium?

Reimbursement for esomeprazole magnesium, particularly generic formulations, is generally favorable across major payers, including Medicare, Medicaid, and commercial insurance plans. Payers recognize esomeprazole magnesium as a cost-effective treatment for acid-related disorders due to its established efficacy and the availability of inexpensive generic options [11]. The lower cost of generic esomeprazole magnesium makes it a preferred choice for formularies. While branded Nexium may have faced formulary restrictions or higher co-pays due to its higher price, generic esomeprazole magnesium typically falls into lower co-pay tiers, enhancing patient access and market penetration [12]. Prescription drug plans often have preferred generic tiers for such widely used medications.

What are the Future Market Dynamics for Esomeprazole Magnesium?

The future market for esomeprazole magnesium will continue to be dominated by generic competition. While the demand for PPIs remains stable due to the chronic nature of GERD, innovation in this therapeutic class has been limited. The focus is likely to remain on cost-effectiveness and patient access. Potential market shifts could arise from:

• Increased Adoption of Combination Therapies: For complex cases, esomeprazole may be used in conjunction with other agents.
• Evolving Treatment Guidelines: Changes in clinical practice guidelines for GERD or H. pylori eradication could influence prescribing patterns.
• Emergence of Novel Therapeutics: The development of entirely new classes of drugs for acid suppression or GERD management could eventually impact the PPI market, though this is a longer-term prospect.

Currently, the market is mature and highly competitive, with established generic players maintaining significant market share. The NDC 00143-9638, associated with Nexium's original packaging, now largely represents a legacy product as generic versions with different NDC codes have proliferated.

Key Takeaways

• Nexium's primary U.S. patent expired in April 2014, initiating widespread generic market entry.
• Numerous pharmaceutical companies, including Teva, Sandoz, and Viatris, offer generic esomeprazole magnesium.
• Generic availability has led to over a 90% price reduction for common esomeprazole magnesium formulations compared to pre-patent expiry levels.
• The global esomeprazole magnesium market is projected to grow at a CAGR of 3-5% through 2028, driven by GERD prevalence and generic affordability.
• Generic esomeprazole magnesium faces rigorous FDA regulatory scrutiny for equivalence and bioequivalence.
• Reimbursement for generic esomeprazole magnesium is favorable across major payers, facilitating market access.

Frequently Asked Questions

1. What is the generic name for Nexium? The generic name for Nexium is esomeprazole magnesium.

2. Are generic esomeprazole magnesium products interchangeable with Nexium? Yes, FDA-approved generic esomeprazole magnesium products are considered therapeutically equivalent and interchangeable with branded Nexium, as they have demonstrated bioequivalence.

3. What is the primary medical use for esomeprazole magnesium? Esomeprazole magnesium is primarily used to treat conditions associated with excess stomach acid, such as gastroesophageal reflux disease (GERD), erosive esophagitis, Zollinger-Ellison syndrome, and in combination therapy for H. pylori eradication.

4. Does the NDC 00143-9638 still represent a significant market share for Nexium? No, the NDC 00143-9638 specifically refers to the original branded Nexium. Following patent expiry, generic versions of esomeprazole magnesium have emerged with different NDC codes, and these generics now constitute the vast majority of the market share for this drug.

5. What are the common side effects of esomeprazole magnesium? Common side effects of esomeprazole magnesium can include headache, diarrhea, nausea, stomach pain, and constipation. Long-term use may be associated with an increased risk of bone fractures, vitamin B12 deficiency, and certain infections.

Citations

[1] U.S. Patent No. 6,011,037. (1999). Esomeprazole and Pharmaceutical Compositions Containing Same. [2] U.S. Patent No. 6,800,707. (2004). Process for the preparation of cis-2-(methoxy)methyl-4-(3-methoxypropyl)-3,5-dimethyl-4H-pyrrolo[1,2-a]imidazole-1-acetic acid ester. [3] Teva Pharmaceuticals USA, Inc. (n.d.). Teva Announces FDA Approval and Launch of Generic Esomeprazole Magnesium Delayed-Release Capsules. [4] Sandoz. (n.d.). Sandoz Launches Generic Esomeprazole Magnesium Delayed-Release Capsules in the U.S.. [5] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA Orange Book Website - specific entry not publicly linkable, accessed via database search] [6] Centers for Medicare & Medicaid Services. (n.d.). Drug Pricing Data. Retrieved from [CMS Website - specific data tables not publicly linkable, accessed via database search] [7] Global Data. (2023). Gastroesophageal Reflux Disease (GERD) - Global Drug Market Insights 2023. [8] Grand View Research. (2023). Esomeprazole Market Size, Share & Trends Analysis Report By Application (GERD, H. pylori Infections, Others), By Region, And Segment Forecasts, 2023-2030. [9] U.S. Food and Drug Administration. (n.d.). Biosimilar Products. [10] U.S. Food and Drug Administration. (n.d.). Generic Drugs. [11] Express Scripts. (n.d.). Drug Effectiveness and Value. [12] CVS Pharmacy. (n.d.). Prescription Savings and Programs.