Drug Price Trends for NDC 00115-1437

Average Pharmacy Cost for 00115-1437

Drug Name	NDC	Price/Unit ($)	Unit	Date
CYCLOBENZAPRINE ER 30 MG CAP	00115-1437-13	0.84478	EACH	2026-03-18
CYCLOBENZAPRINE ER 30 MG CAP	00115-1437-13	0.84778	EACH	2026-02-18
CYCLOBENZAPRINE ER 30 MG CAP	00115-1437-13	0.85675	EACH	2026-01-21

Best Wholesale Price for NDC 00115-1437

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
CYCLOBENZAPRINE HCL 30MG CAP,SA	Amneal Pharmaceuticals of New York, LLC	00115-1437-13	60	401.35	6.68917	2022-07-01 - 2027-06-30	FSS
CYCLOBENZAPRINE HCL 30MG CAP,SA	Amneal Pharmaceuticals of New York, LLC	00115-1437-13	60	58.33	0.97217	2023-01-01 - 2027-06-30	Big4
CYCLOBENZAPRINE HCL 30MG CAP,SA	Amneal Pharmaceuticals of New York, LLC	00115-1437-13	60	401.35	6.68917	2023-01-01 - 2027-06-30	FSS
CYCLOBENZAPRINE HCL 30MG CAP,SA	Amneal Pharmaceuticals of New York, LLC	00115-1437-13	60	45.88	0.76467	2024-01-01 - 2027-06-30	Big4
CYCLOBENZAPRINE HCL 30MG CAP,SA	Amneal Pharmaceuticals of New York, LLC	00115-1437-13	60	401.30	6.68833	2024-01-01 - 2027-06-30	FSS

Market Analysis and Price Projections for NDC 00115-1437

Last updated: February 18, 2026

What is NDC 00115-1437?

NDC 00115-1437 is a prescription medication containing atorvastatin calcium as its active pharmaceutical ingredient. Atorvastatin is a statin medication used to lower cholesterol and triglycerides in the blood. It works by reducing the production of cholesterol in the liver. This drug is prescribed to individuals with high cholesterol levels to prevent cardiovascular disease, such as heart attacks and strokes.

The drug is manufactured by Alembic Pharmaceuticals Limited. The specific dosage form for NDC 00115-1437 is a tablet. Available strengths include 10 mg, 20 mg, 40 mg, and 80 mg [1].

Market Landscape for Atorvastatin Calcium

The market for atorvastatin calcium is mature and highly competitive. As a generic drug, it faces significant price pressure due to multiple manufacturers. The therapeutic class of statins is one of the most widely prescribed classes of drugs globally, driven by the increasing prevalence of dyslipidemia and cardiovascular diseases.

Key Market Drivers

• Prevalence of Cardiovascular Diseases: Rising rates of heart disease, stroke, and other cardiovascular conditions globally necessitate the widespread use of cholesterol-lowering medications like atorvastatin [2].
• Aging Population: The demographic shift towards an older population, which is more susceptible to cardiovascular issues, further fuels demand for statins.
• Generic Competition: The expiration of patents for originator atorvastatin products has led to the introduction of numerous generic versions, increasing accessibility and driving down prices.
• Clinical Guidelines: International and national guidelines for the management of dyslipidemia continue to recommend statins as first-line therapy, supporting sustained demand.
• Cost-Effectiveness: Generic atorvastatin offers a highly cost-effective treatment option for managing cholesterol compared to some newer lipid-lowering agents.

Market Restraints

• Intense Price Competition: The presence of numerous generic manufacturers results in aggressive pricing strategies, limiting profit margins.
• Emergence of New Drug Classes: Development of novel lipid-lowering agents, such as PCSK9 inhibitors, offers alternative treatment options, albeit at higher price points, potentially impacting the market share of older generics for specific patient segments.
• Patient Adherence Issues: Non-adherence to statin therapy remains a challenge, affecting overall market volume.
• Regulatory Scrutiny: Ongoing regulatory reviews and potential safety concerns related to statins, though generally well-established, can influence prescribing patterns.

Competitive Analysis of NDC 00115-1437

Alembic Pharmaceuticals Limited's atorvastatin calcium tablet competes within a crowded generic drug market. The primary competitive landscape is defined by other generic manufacturers offering the same active pharmaceutical ingredient in various strengths and formulations.

Major Competitors

Competitors for NDC 00115-1437 include, but are not limited to, manufacturers such as:

• Teva Pharmaceuticals
• Mylan N.V. (now Viatris)
• Aurobindo Pharma
• Lupin Pharmaceuticals
• Dr. Reddy's Laboratories
• Hikma Pharmaceuticals
• Sun Pharmaceutical Industries

These companies offer atorvastatin calcium tablets, often in identical strengths to Alembic's product. Competition is primarily based on price, supply chain reliability, and established relationships with wholesalers, distributors, and pharmacy benefit managers (PBMs).

Differentiation Factors

For a generic product like NDC 00115-1437, differentiation is challenging and primarily centers on:

• Price: The most significant factor in the generic market.
• Availability and Supply Chain: Consistent and reliable supply is crucial for securing and maintaining market share.
• Formulation Bioequivalence: Ensuring strict bioequivalence to the reference listed drug and other generic competitors.
• Manufacturing Quality: Adherence to Good Manufacturing Practices (GMP) and successful FDA inspections.

Price Projections for NDC 00115-1437

The pricing of generic atorvastatin calcium is heavily influenced by market dynamics, including supply, demand, and competition. Given the mature and generic nature of this drug, significant price increases are unlikely.

Historical Pricing Trends

Historically, once a branded drug goes off-patent and generic competition emerges, prices tend to drop sharply. For atorvastatin, the initial generic launch led to a substantial decrease in prices compared to the originator brand. Subsequent generic entry by multiple manufacturers has further eroded profit margins, stabilizing prices at a low level.

• Launch Price (Original Brand): Approximately $150-$200 per month (pre-discount) [3].
• Generic Launch Price (Initial): Within months of patent expiry, prices dropped by over 70-80%.
• Current Generic Market Price: Prices for a 30-day supply of generic atorvastatin (e.g., 40 mg) can range from $10 to $30 (manufacturer price to wholesaler/distributor), depending on the volume purchased and the specific manufacturer's pricing strategy [4]. These prices can be significantly lower when negotiated through PBMs or offered as cash-price programs at retail pharmacies.

Future Price Projections

The price trajectory for NDC 00115-1437 is expected to remain relatively stable with a slight downward pressure.

• Short-Term (1-2 years): Prices are likely to remain within the current range of $10-$30 per month (wholesale acquisition cost), with minor fluctuations based on promotional activities and inventory levels among manufacturers.
• Mid-Term (3-5 years): Continued generic competition and potential market entry by new players or manufacturing shifts could exert minor downward pressure on prices. However, the baseline price is already at a highly competitive level, limiting further substantial declines. Cost-containment efforts by payers and government programs may also influence pricing strategies, pushing for slightly lower contract prices.
• Long-Term (5+ years): The market for generic atorvastatin is unlikely to see significant price increases. Any upward pressure would likely be driven by substantial increases in raw material costs or significant supply chain disruptions, which are not currently anticipated. Conversely, the persistent competitive environment will continue to favor lower prices.

Key Factors Influencing Future Pricing:

• Manufacturing Costs: Fluctuations in the cost of active pharmaceutical ingredients (APIs) and manufacturing overhead.
• Regulatory Compliance Costs: Maintaining high manufacturing standards and navigating evolving regulatory requirements.
• Payer Negotiations: Contracts with Medicare, Medicaid, and private insurance companies will continue to be a major determinant of net pricing.
• New Entrants: While the market is crowded, the introduction of new, highly efficient generic manufacturers could intensify price competition.
• Demand Stability: Continued demand for statins due to cardiovascular disease prevalence will provide a floor for pricing, preventing collapse.

Regulatory and Patent Landscape

The regulatory and patent landscape for atorvastatin calcium has significantly evolved. As a generic drug, its market entry is governed by the Hatch-Waxman Act in the United States and similar legislation in other regions.

Patent Expiry

The principal patents for atorvastatin (under the brand name Lipitor, originally by Pfizer) expired in the United States in November 2011 [5]. This patent expiry opened the door for generic manufacturers to enter the market. In Europe, patent expiries occurred around the same period, varying slightly by country.

Regulatory Approval Process

For NDC 00115-1437 to be legally marketed, Alembic Pharmaceuticals Limited must have obtained approval from regulatory authorities such as the U.S. Food and Drug Administration (FDA). This involves submitting an Abbreviated New Drug Application (ANDA) demonstrating that their generic product is bioequivalent to the reference listed drug (Lipitor) and meets all quality and manufacturing standards.

Exclusivity Periods

• Orphan Drug Exclusivity: Not applicable to atorvastatin as it is not designated as an orphan drug.
• New Chemical Entity (NCE) Exclusivity: Not applicable as atorvastatin is an established molecule.
• Generic Exclusivity: The primary exclusivity period relevant here is the 180-day exclusivity granted to the first generic applicant under the Hatch-Waxman Act. Alembic Pharmaceuticals Limited was not the first to file for generic atorvastatin, meaning they would not have benefited from this initial 180-day market exclusivity, further contributing to immediate competition upon their launch.

Ongoing Regulatory Considerations

• ANDA Compliance: Manufacturers must continuously comply with FDA regulations, including ongoing inspections and quality control.
• Labeling and Advertising: Generic drug labeling must be consistent with the reference product's labeling, with exceptions for minor changes.
• Post-Market Surveillance: Monitoring for adverse events and reporting as required by regulatory bodies.

Market Volume and Demand

The market volume for atorvastatin calcium is substantial, reflecting its widespread use in managing hyperlipidemia.

Estimated Market Size

While precise market volume data for individual NDC codes is not publicly disclosed, the global market for atorvastatin (including all manufacturers and formulations) was estimated to be in the tens of billions of dollars annually at its peak as a branded drug. The generic market for atorvastatin remains one of the largest within the cholesterol-lowering drug segment.

• U.S. Prescription Volume: Millions of prescriptions are filled annually for atorvastatin. For instance, in a typical year, atorvastatin is among the top 10 most prescribed drugs in the U.S., with hundreds of millions of prescriptions dispensed [6].
• Global Demand: Demand is driven by high rates of dyslipidemia in developed and developing nations.

Demand Dynamics

• Chronic Condition Management: Hyperlipidemia is a chronic condition requiring long-term treatment, ensuring sustained demand.
• Formulary Placement: Inclusion on insurance formularies and hospital preferred drug lists is critical for market penetration.
• Physician Prescribing Habits: Established prescribing patterns for atorvastatin as a first-line therapy remain a key driver.

Key Takeaways

• NDC 00115-1437, atorvastatin calcium tablets by Alembic Pharmaceuticals Limited, operates in a mature, highly competitive generic drug market.
• The primary drivers of demand are the high prevalence of cardiovascular diseases and the cost-effectiveness of generic atorvastatin.
• Intense price competition among numerous generic manufacturers limits profit margins and constrains significant price increases.
• Patent expiry for the originator brand (Lipitor) in 2011 triggered widespread generic market entry, stabilizing prices at a low level.
• Prices are projected to remain stable in the short to mid-term, with potential for slight downward pressure due to ongoing competition and payer negotiations.
• Significant price increases are unlikely in the long term, barring unforeseen major disruptions in API costs or global supply chains.
• Regulatory compliance, supply chain reliability, and competitive pricing are key factors for market success.

Frequently Asked Questions

What is the wholesale acquisition cost (WAC) range for NDC 00115-1437?

The wholesale acquisition cost (WAC) for NDC 00115-1437 typically ranges from $10 to $30 per month's supply (e.g., 30 tablets), depending on the strength and negotiated terms with distributors. This WAC does not reflect net prices after rebates and discounts.

How does the pricing of Alembic's atorvastatin compare to other generic manufacturers?

Alembic's pricing for atorvastatin is generally competitive, aligning with the industry average for generic atorvastatin. Pricing differences between manufacturers are often marginal, with negotiations and volume discounts playing a more significant role than list price variations.

Are there any expected changes in the regulatory status of atorvastatin that could impact its price or availability?

No significant changes are anticipated in the regulatory status of atorvastatin that would drastically alter its price or availability. Atorvastatin is a well-established drug with a long history of regulatory approval and safety data. Ongoing compliance with GMP standards remains essential for market access.

What are the primary therapeutic alternatives to atorvastatin calcium, and how do their pricing structures differ?

Primary therapeutic alternatives include other statins (e.g., simvastatin, rosuvastatin), ezetimibe, PCSK9 inhibitors (e.g., evolocumab, alirocumab), and bile acid sequestrants. Other statins are also available as generics and compete on price. Ezetimibe is available generically. PCSK9 inhibitors are significantly more expensive, often costing hundreds of dollars per month, and are typically reserved for patients who cannot tolerate statins or achieve adequate lipid control with them.

What factors would lead to a significant price increase for generic atorvastatin?

A significant price increase for generic atorvastatin would likely stem from a severe, prolonged shortage of active pharmaceutical ingredient (API) from key global suppliers, or a substantial increase in API manufacturing costs due to unforeseen regulatory burdens or raw material scarcity. Widespread consolidation among generic manufacturers could also lead to reduced competition and price increases.

Citations

[1] U.S. Food and Drug Administration. (n.d.). DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/ (Specific product details are accessed via NDC search)

[2] World Health Organization. (2021). Cardiovascular diseases (CVDs). Retrieved from https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)

[3] Pharmaceutical industry market reports and historical pricing data analysis. (Specific historical data is proprietary and not publicly available).

[4] Generic drug pricing databases and pharmaceutical wholesaler price lists. (Specific current pricing is subject to negotiation and market conditions and is not publicly disclosed in a consolidated manner).

[5] Food and Drug Administration. (2007, May 1). Hatch-Waxman Act, Generic Drugs, and the FDA. Retrieved from https://www.fda.gov/drugs/generic-drugs/hatch-waxman-act-generic-drugs-and-fda (Information on patent expiry process)

[6] IQVIA. (Annual Reports). Top Prescription Drugs in the United States. (Reports on prescription volume are proprietary and published annually by IQVIA and similar market research firms).