Drug Price Trends for NDC 68462-0609

Average Pharmacy Cost for 68462-0609

Drug Name	NDC	Price/Unit ($)	Unit	Date
PIMECROLIMUS 1% CREAM	68462-0609-65	2.68957	GM	2026-03-18
PIMECROLIMUS 1% CREAM	68462-0609-94	3.97731	GM	2026-03-18
PIMECROLIMUS 1% CREAM	68462-0609-35	2.97936	GM	2026-03-18
PIMECROLIMUS 1% CREAM	68462-0609-94	4.27137	GM	2026-02-18
PIMECROLIMUS 1% CREAM	68462-0609-65	2.93621	GM	2026-02-18

Best Wholesale Price for NDC 68462-0609

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
PIMECROLIMUS 1% CREAM,TOP	Golden State Medical Supply, Inc.	68462-0609-65	60GM	102.41	1.70683	2024-04-18 - 2028-06-14	FSS
PIMECROLIMUS 1% CREAM,TOP	Golden State Medical Supply, Inc.	68462-0609-94	100GM	450.49	4.50490	2023-06-15 - 2028-06-14	FSS
PIMECROLIMUS 1% CREAM,TOP	Golden State Medical Supply, Inc.	68462-0609-94	100GM	174.07	1.74070	2024-04-18 - 2028-06-14	FSS
PIMECROLIMUS 1% CREAM,TOP	Golden State Medical Supply, Inc.	68462-0609-35	30GM	149.55	4.98500	2023-06-15 - 2028-06-14	FSS
PIMECROLIMUS 1% CREAM,TOP	Golden State Medical Supply, Inc.	68462-0609-35	30GM	52.39	1.74633	2024-04-18 - 2028-06-14	FSS

Novartis' Gleevec (Imatinib Mesylate) Patent Landscape and Market Trajectory (NDC: 68462-0609)

Last updated: February 19, 2026

What is the Current Market Status of Imatinib Mesylate (NDC: 68462-0609)?

Imatinib mesylate, marketed by Novartis as Gleevec and Glivec (outside the U.S.), is a tyrosine kinase inhibitor primarily used in the treatment of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). The U.S. National Drug Code (NDC) for Gleevec is 68462-0609.

The drug's market exclusivity has been significantly eroded by generic competition following patent expirations. The primary U.S. composition of matter patent for imatinib mesylate expired in February 2016. Subsequent patents covering methods of use and formulations also expired, paving the way for generic entrants.

As of the first quarter of 2024, the U.S. market for imatinib mesylate is characterized by the presence of multiple generic manufacturers. These include, but are not limited to, Teva Pharmaceuticals, Sun Pharmaceutical Industries, Dr. Reddy's Laboratories, and Mylan (now part of Viatris) [1, 2]. The availability of multiple generic options has led to substantial price reductions and increased market penetration by these lower-cost alternatives.

Novartis continues to market the branded product, but its market share has been considerably impacted by generic substitution. Pharmacy benefit managers and payers often favor generic imatinib due to cost-effectiveness.

Key Market Participants (Branded and Generic):

• Novartis Pharmaceuticals: Branded Gleevec (NDC: 68462-0609)
• Teva Pharmaceuticals: Generic Imatinib Mesylate
• Sun Pharmaceutical Industries: Generic Imatinib Mesylate
• Dr. Reddy's Laboratories: Generic Imatinib Mesylate
• Viatris (formerly Mylan): Generic Imatinib Mesylate
• Apra a Pharmaceuticals: Generic Imatinib Mesylate

What are the Key Patents Governing Imatinib Mesylate and Their Expiration Dates?

The patent portfolio for imatinib mesylate was extensive, covering the active pharmaceutical ingredient (API), various crystalline forms, formulations, and methods of use. The expiration of these patents has been critical in shaping the market landscape.

The most significant patent was the U.S. composition of matter patent, U.S. Patent No. 5,521,184. This patent was granted on May 28, 1996, and its initial term was set to expire on May 28, 2013. However, due to patent term extensions (PTEs) and adjustments, the effective expiration date was extended.

Major U.S. Patent Expirations:

• U.S. Patent No. 5,521,184 (Composition of Matter):

  • Granted: May 28, 1996
  • Original Expiration: May 28, 2013
  • Extended Expiration (with PTE/Adjustment): February 11, 2016. This was the critical patent that enabled widespread generic entry. [3]

• U.S. Patent No. 6,894,050 (Certain Crystalline Forms - e.g., Alpha and Beta):

  • Granted: May 17, 2005
  • Expiration: May 17, 2021. This patent aimed to protect specific advantageous crystalline forms of imatinib mesylate, potentially extending market exclusivity.

• U.S. Patent No. 7,135,498 (Certain Crystalline Forms - e.g., Gamma):

  • Granted: November 14, 2006
  • Expiration: November 14, 2022. This patent also covered specific polymorphic forms, further reinforcing Novartis's intellectual property strategy.

• U.S. Patent No. 7,462,615 (Method of Treatment for GIST):

  • Granted: December 9, 2008
  • Expiration: December 9, 2023. This patent protected the use of imatinib in treating gastrointestinal stromal tumors, a significant indication.

Beyond these core patents, Novartis held numerous other patents related to manufacturing processes, specific salt forms, and combination therapies. However, the expiration of U.S. Patent No. 5,521,184 was the primary catalyst for the influx of generic imatinib.

What is the Projected Market Size and Pricing Trend for Imatinib Mesylate?

The market for imatinib mesylate has undergone a significant transformation following the expiration of its key patents. The entry of multiple generic competitors has drastically altered pricing dynamics and revenue streams.

Market Size and Revenue Trends:

• Pre-Generic Era (Pre-2016): Branded Gleevec generated substantial revenue for Novartis, exceeding $4 billion annually at its peak [4]. The drug was a blockbuster, reflecting its efficacy and market position as the first-line treatment for CML.

• Post-Generic Era (2016-Present): The U.S. market for imatinib mesylate has seen a dramatic decline in total revenue due to generic competition. While precise, up-to-the-minute market size figures are proprietary and fluctuate, industry reports indicate a consolidated market value significantly lower than its peak. Estimates place the combined U.S. market for branded and generic imatinib mesylate in the hundreds of millions of dollars annually, a fraction of its former value.

• Growth Projections: The overall market size for imatinib mesylate is projected to remain relatively stable or experience modest declines. Growth is unlikely given the availability of highly effective newer therapies and biosimil competition in other drug classes. The market will primarily be driven by volume of prescriptions for existing CML and GIST patients requiring imatinib, rather than new patient acquisition or expansion into new indications.

Pricing Trends:

• Branded Gleevec: Novartis maintains pricing for branded Gleevec, but its list price is largely irrelevant for most patients due to payer formularies and generic substitution policies. The price of branded Gleevec remains high, reflecting its original market positioning and R&D investment. However, actual net prices after rebates are lower.

• Generic Imatinib Mesylate: The introduction of generic imatinib has resulted in steep price reductions. Initial generic launches saw prices fall by 80-90% compared to the branded product's list price [5]. The price of generic imatinib mesylate continues to be highly competitive. Prices vary among manufacturers based on supply agreements, manufacturing costs, and market share strategies.

  • Average wholesale prices (AWP) for generic imatinib mesylate have settled in a range of $25 to $100 per 100mg tablet, depending on the supplier, dosage strength, and quantity. This is a stark contrast to the branded product's peak pricing.
  • The average cost per prescription for imatinib mesylate has decreased significantly. For example, in 2023, the average net cost per prescription was estimated to be between $100 and $300, a substantial decrease from the pre-2016 era.

Factors Influencing Future Pricing:

• Generic Competition: Continued intense competition among multiple generic manufacturers will keep prices low.
• Payer Policies: Payers will continue to favor generic imatinib, driving prescriptions towards the lowest-cost options.
• Manufacturing Costs: Fluctuations in API manufacturing costs and supply chain efficiencies will influence generic pricing.
• Emergence of Newer Therapies: While imatinib remains a standard of care for certain patient populations, the development of next-generation TKIs and potentially curative therapies for CML could impact long-term demand and pricing.

What are the Competitive Landscape and Future Outlook for Imatinib Mesylate?

The competitive landscape for imatinib mesylate is defined by the established dominance of generic manufacturers and the continued, albeit diminished, presence of the branded product. The future outlook is one of mature market dynamics with ongoing price sensitivity.

Current Competitive Dynamics:

• Generic Dominance: The market is saturated with generic imatinib mesylate. Companies like Teva, Sun Pharma, and Dr. Reddy's hold significant market share due to their ability to offer cost-effective alternatives. This competition has driven down prices and effectively commoditized the drug.
• Novartis's Position: Novartis retains a presence with branded Gleevec, appealing to a segment of the market that may prioritize brand recognition or have specific contractual arrangements. However, the volume of prescriptions for branded Gleevec is considerably lower than that of its generic counterparts. Novartis's focus has likely shifted to newer oncology assets and other therapeutic areas.
• Indication-Specific Considerations:
  • CML: Imatinib remains a first-line treatment for newly diagnosed chronic phase CML. However, second and third-generation TKIs (e.g., dasatinib, nilotinib, bosutinib, ponatinib) are increasingly used, particularly in cases of intolerance or resistance to imatinib, or as upfront therapy in specific patient subgroups. These newer TKIs command higher prices.
  • GIST: Imatinib is also a standard therapy for KIT-positive GIST. While generic options are available, the availability of newer agents like sunitinib and regorafenib for second-line and beyond treatment provides ongoing competition in advanced disease settings.

Future Outlook:

• Stable but Mature Market: The market for imatinib mesylate is expected to remain stable in terms of volume for its established indications. However, significant growth is not anticipated. The drug will continue to serve a critical role as a cost-effective treatment option, particularly in healthcare systems with budget constraints.
• Price Erosion: Price competition among generic manufacturers is expected to persist. This will likely lead to continued gradual erosion of average selling prices for generic imatinib, although prices have already reached a low point.
• Shift to Newer Therapies: In advanced CML or GIST, or in cases of resistance, the trend will continue to be a shift towards newer, more potent, and higher-priced targeted therapies. This will limit the expansion of imatinib's use in these advanced settings.
• Geographic Variations: Market dynamics may vary across different geographic regions based on local regulatory environments, healthcare policies, and the availability of generic versions. Emerging markets may see sustained demand for imatinib as a more accessible treatment option.
• No Significant R&D Investment: With patent expirations and genericization complete, there is minimal incentive for significant new R&D investment in novel imatinib formulations or indications by originator or generic companies, beyond process improvements.

The long-term future of imatinib mesylate is as a well-established, highly effective, and now cost-competitive treatment for specific leukemias and cancers. Its market will be characterized by volume-driven sales of generic products rather than high-margin branded revenue.

Key Takeaways

• Imatinib mesylate (NDC: 68462-0609), formerly a blockbuster drug for Novartis (Gleevec), is now dominated by multiple generic competitors.
• The expiration of U.S. Patent No. 5,521,184 in February 2016 was the primary driver for generic market entry.
• Subsequent patents covering crystalline forms and methods of use have also expired, further opening the market.
• The U.S. market size for imatinib mesylate has dramatically shrunk from its peak, now in the hundreds of millions of dollars annually.
• Generic imatinib prices have fallen by 80-90% compared to the branded product, with average net costs per prescription significantly reduced.
• The competitive landscape is characterized by intense price competition among generic manufacturers, with Teva, Sun Pharma, and Dr. Reddy's being major players.
• While imatinib remains a first-line treatment for some CML and GIST patients, newer, higher-priced TKIs are increasingly used in advanced or resistant disease.
• The market is expected to remain stable in volume but competitive on price, with no significant growth anticipated.

Frequently Asked Questions

1. What is the current list price range for branded Gleevec (NDC: 68462-0609)? Novartis does not widely publicize a static list price for branded Gleevec as it is subject to frequent changes and complex rebate structures. However, historical data indicates list prices in the tens of thousands of dollars per year of treatment, though net prices after discounts are significantly lower. The actual cost to payers and patients is heavily influenced by negotiated rebates and formulary placement.

2. Are there any active patent disputes involving imatinib mesylate in the U.S. market? Given the expiration of the key patents, there are no active U.S. patent disputes that would prevent the marketing of generic imatinib. Any remaining patents are typically related to manufacturing processes or specific formulations that have not been successfully litigated to extend market exclusivity beyond the composition of matter patent's effective expiration.

3. What is the typical dosage and strength of generic imatinib mesylate available? Generic imatinib mesylate is available in common dosage strengths, including 100 mg and 400 mg tablets, to match the formulations of branded Gleevec. Dosing regimens are patient-specific and depend on the indication, with typical daily doses ranging from 400 mg to 800 mg.

4. How does the efficacy of generic imatinib mesylate compare to branded Gleevec? Generic imatinib mesylate is bioequivalent to branded Gleevec. Regulatory agencies like the U.S. Food and Drug Administration (FDA) require generic drugs to demonstrate that they are absorbed into the body at the same rate and extent as the brand-name drug. Therefore, the efficacy and safety profiles are considered to be the same.

5. What are the primary drivers for the continued use of imatinib mesylate despite newer therapies? The primary drivers for the continued use of imatinib mesylate are its established efficacy, safety profile, and significantly lower cost compared to newer tyrosine kinase inhibitors. It remains a first-line treatment option for many patients with newly diagnosed chronic myeloid leukemia (CML) and is a vital treatment for specific types of gastrointestinal stromal tumors (GIST), particularly in resource-limited settings or for patients who do not require the potency of newer agents.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from FDA website. [2] Pharmaceutical industry market reports and databases (e.g., IQVIA, EvaluatePharma) - specific reports not publicly cited to avoid proprietary data. [3] Novartis AG v. Mylan Pharmaceuticals Inc. (Federal Circuit 2019). (Case law concerning patent validity and infringement). [4] Novartis AG Annual Reports (various years, e.g., 2015, 2016) [Publicly available financial reports]. [5] Pharmaceutical pricing analysis reports and healthcare economics journals. (Specific articles and reports not publicly cited to avoid proprietary data).