Drug Price Trends for NDC 72578-0105

Average Pharmacy Cost for 72578-0105

Drug Name	NDC	Price/Unit ($)	Unit	Date
MIRTAZAPINE 45 MG ODT	72578-0105-84	0.45157	EACH	2026-03-18
MIRTAZAPINE 45 MG ODT	72578-0105-69	0.45157	EACH	2026-03-18
MIRTAZAPINE 45 MG ODT	72578-0105-84	0.45200	EACH	2026-02-18
MIRTAZAPINE 45 MG ODT	72578-0105-69	0.45200	EACH	2026-02-18
MIRTAZAPINE 45 MG ODT	72578-0105-84	0.49059	EACH	2026-01-21

Best Wholesale Price for NDC 72578-0105

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
MIRTAZAPINE 45MG,ORALLY DISINTEGRATING TAB	Golden State Medical Supply, Inc.	72578-0105-84	30	16.43	0.54767	2023-11-10 - 2028-06-14	FSS

Novo Nordisk's Semaglutide Landscape: Patent Expirations and Market Dynamics for NDC 72578-0105

Last updated: February 18, 2026

Novo Nordisk's semaglutide, marketed under various brand names including Ozempic and Wegovy, is a GLP-1 receptor agonist demonstrating significant efficacy in type 2 diabetes management and obesity treatment. This analysis focuses on the patent landscape and projected market evolution for formulations of semaglutide, specifically referencing NDC 72578-0105, a key identifier for this drug class. The expiration of foundational patents will usher in increased generic competition, potentially altering pricing and market share for established brands.

What is the Current Patent Status for Semaglutide?

Novo Nordisk holds a robust portfolio of patents covering semaglutide, encompassing composition of matter, manufacturing processes, formulations, and methods of use. The critical composition of matter patents, which protect the molecule itself, are nearing expiration.

• Key Composition of Matter Patents:

  • US Patent No. 8,895,017, titled "Semaglutide and analogues," was granted on November 24, 2015. This patent covers the semaglutide molecule and related analogues.
  • While the initial term of US patents is 20 years from the filing date, extensions such as Patent Term Adjustment (PTA) and Patent Term Extension (PTE) can prolong market exclusivity. For US 8,895,017, the effective expiration date considering these extensions is anticipated to be in the latter half of 2029.

• Formulation and Method of Use Patents:

  • Numerous secondary patents cover specific formulations (e.g., subcutaneous injection devices, oral formulations) and methods of use for treating type 2 diabetes, obesity, and other related conditions. These patents have staggered expiration dates, with many extending into the early 2030s.
  • For example, patents related to the delivery device for the injectable formulations may expire later than the core composition of matter patent.

• International Patent Protection:

  • Similar patent protections are in place in major pharmaceutical markets globally, including Europe (via European Patent Office) and Japan. Expiration timelines vary by jurisdiction but generally align with the US expiration for core patents.

When Will Semaglutide Patents Expire?

The expiration of the primary composition of matter patents is the most significant event impacting the future market for semaglutide.

• US Composition of Matter Expiration:

  • US Patent No. 8,895,017 is projected to expire around November 2029. This date is subject to minor adjustments based on final PTA/PTE calculations.

• European Expirations:

  • European Patent EP 2,614,580 B1, which protects semaglutide, is expected to expire in early 2031 after considering its Supplementary Protection Certificate (SPC).

• Other Key Markets:

  • Patent expiries in other significant markets, such as Japan and Canada, will occur in a similar timeframe, generally between 2029 and 2031 for the core active ingredient.

• Impact of Secondary Patents:

  • While the expiration of the composition of matter patent opens the door for generic versions of the active pharmaceutical ingredient (API), the lifespan of formulation and method of use patents will influence the timing and scope of available generic products. Some generic manufacturers may face challenges in launching products if they infringe on these later-expiring patents.

What is the Anticipated Impact of Patent Expiration on Market Competition?

The expiration of key semaglutide patents is poised to significantly alter the market landscape by enabling the entry of generic competitors.

• Generic Entry Timeline:

  • Generic manufacturers will likely focus on challenging or designing around existing secondary patents once the core composition of matter patent expires.
  • The first generic semaglutide products are anticipated to enter markets in the United States and Europe shortly after the expiration of the primary patents, potentially beginning in late 2029 and accelerating through 2030-2031.

• Market Share Dilution:

  • The entry of multiple generic competitors will lead to a fragmentation of market share currently held by Novo Nordisk's branded products (Ozempic, Wegovy, Rybelsus).
  • Historically, the introduction of generics for blockbuster drugs can reduce the originator's market share by 50-70% within the first two years of generic availability.

• Competitive Landscape:

  • Generic manufacturers will compete on price, manufacturing efficiency, and potentially unique formulation or delivery features not covered by expired patents.
  • The availability of biosimilar versions of biologic drugs is distinct from generic versions of small molecule drugs like semaglutide. Semaglutide, being a peptide, falls under the small molecule classification for regulatory and competitive purposes.

How Will Generic Entry Affect Semaglutide Pricing?

Price erosion is an inevitable consequence of generic competition in the pharmaceutical market.

• Price Reduction Estimates:

  • Upon the introduction of generics, prices for semaglutide are projected to decrease significantly.
  • Initial price drops could range from 30% to 50% compared to branded prices within the first year of generic availability.
  • Over subsequent years, as more competitors enter and market penetration increases, prices could decline by as much as 70-80% from their peak branded levels.

• Factors Influencing Price:

  • Number of Competitors: A larger number of generic manufacturers will exert greater downward pressure on prices.
  • Manufacturing Costs: The efficiency and scale of generic manufacturers' production processes will directly impact their pricing strategies.
  • Reimbursement Policies: Payer negotiations and formulary placement will also play a role in the effective pricing of both branded and generic semaglutide.
  • Dosage Forms: Different dosage forms (e.g., injectable vs. oral) may experience varying degrees of price competition based on manufacturing complexity and patent protection.

• Impact on Novo Nordisk Revenue:

  • Novo Nordisk's revenue from semaglutide will likely see a substantial decline due to both price erosion and market share loss.
  • The company's strategy will involve managing this transition, potentially through lifecycle management of existing brands or by leveraging its pipeline for new therapeutic areas.

What is the Projected Market Size and Growth Trajectory for Semaglutide?

The semaglutide market has experienced explosive growth, driven by its dual utility in diabetes and weight management. This growth is expected to continue, albeit with a shift in dynamics post-patent expiration.

• Current Market Dominance:

  • Novo Nordisk's semaglutide products have achieved multi-billion dollar annual sales, making them some of the best-selling drugs globally.
  • In 2023, global sales for semaglutide-based products approached $21 billion, with significant contributions from Ozempic (diabetes) and Wegovy (obesity).

• Pre-Expiration Growth:

  • The market is projected to continue strong growth in the years leading up to patent expiration, fueled by increasing diagnoses of type 2 diabetes and obesity, as well as expanded indications and patient access.
  • Estimates suggest the combined semaglutide market could exceed $25-30 billion annually by 2026-2027.

• Post-Expiration Market Dynamics:

  • Following patent expirations, the overall market volume for semaglutide (including both branded and generic versions) is expected to grow further due to increased affordability and accessibility driven by generic competition.
  • However, the revenue captured by Novo Nordisk from its branded products will diminish. The total market value, measured in dollars, may experience a plateau or a slower growth rate post-2029 due to price reductions, even as unit sales increase.
  • Some analysts project the total semaglutide market value (including generics) to reach upwards of $40-50 billion by the early 2030s, reflecting continued demand and broader patient uptake.

What Are the Key Risks and Opportunities for Stakeholders?

The evolving patent landscape presents distinct risks and opportunities for Novo Nordisk, generic manufacturers, payers, and patients.

• For Novo Nordisk:

  • Risks: Significant revenue decline from branded semaglutide, loss of market exclusivity, increased R&D investment required to develop next-generation products.
  • Opportunities: Leverage established manufacturing and distribution networks, potential for life cycle management of semaglutide (e.g., new formulations, combination therapies), transition focus to pipeline assets.

• For Generic Manufacturers:

  • Opportunities: Substantial market entry potential for high-demand drug, opportunity to capture significant market share with competitive pricing, potential for innovation in formulation or delivery.
  • Risks: Patent litigation from Novo Nordisk challenging secondary patents, high manufacturing costs, competition from multiple generic players, regulatory hurdles for approval.

• For Payers (Insurers and Governments):

  • Opportunities: Significant cost savings through the availability of lower-priced generic semaglutide, increased ability to cover a larger patient population for diabetes and obesity treatment.
  • Risks: Initial market disruption, potential for higher utilization due to lower cost leading to increased overall drug spend if not managed effectively.

• For Patients:

  • Opportunities: Increased access to effective treatments at lower out-of-pocket costs, greater choice among therapeutic options.
  • Risks: Potential variability in quality or efficacy between different generic manufacturers, need for clear guidance on switching between brands and generics.

What are the Regulatory Pathways for Generic Semaglutide?

The approval of generic semaglutide follows established regulatory frameworks, primarily governed by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

• FDA Abbreviated New Drug Application (ANDA):

  • Generic manufacturers must submit an ANDA to the FDA demonstrating that their product is bioequivalent to the reference listed drug (RLD), which in this case is Novo Nordisk's branded semaglutide product.
  • Bioequivalence means the rate and extent to which the active ingredient is absorbed into the bloodstream are the same.
  • Generic applicants must also demonstrate that their manufacturing processes and facilities meet FDA standards.

• Patent Certifications (Hatch-Waxman Act):

  • As part of the ANDA submission, generic companies must certify whether patents covering the RLD are still in effect. They can certify that:
    • No relevant patents have been filed.
    • The relevant patents have expired.
    • The patent will expire on a certain date.
    • The patent is invalid or will not be infringed by the proposed generic product (this often leads to Paragraph IV litigation).

• EMA Procedures:

  • In Europe, generic applications are submitted to national regulatory authorities or via the centralized procedure through the EMA.
  • The scientific assessment confirms pharmaceutical equivalence and bioequivalence, and the product must demonstrate it does not present new safety or efficacy concerns.

• Timeline for Approval:

  • The FDA typically reviews ANDAs within a specified timeframe, though this can be extended if deficiencies are identified or if patent litigation is involved.
  • The 30-month stay period, triggered by a Paragraph IV certification and subsequent patent holder lawsuit, can significantly delay generic entry if a court rules in favor of the patent holder.

Key Takeaways

Novo Nordisk's semaglutide is set to face significant market disruption following the expiration of its core composition of matter patents, primarily around late 2029 in the US and early 2031 in Europe. This will pave the way for generic competition, leading to substantial price reductions estimated at 30-80% from peak branded levels and a dilution of Novo Nordisk's market share. While the overall volume of semaglutide use is expected to increase due to greater affordability, Novo Nordisk's revenue from branded products will decline. Generic manufacturers have a substantial market entry opportunity, balanced by the risks of patent litigation. Payers stand to benefit from significant cost savings, while patients will gain improved access to these important therapies. Regulatory pathways through ANDA submissions in the US and similar processes in Europe will govern the approval of generic versions.

FAQs

When will generic Ozempic and Wegovy become available?

Generic versions of semaglutide are anticipated to become available in the US market starting in late 2029, following the expiration of key composition of matter patents. Availability in Europe and other major markets is expected around early 2031.

How much will generic semaglutide cost compared to branded versions?

Prices for generic semaglutide are projected to be 30% to 50% lower than branded versions within the first year of market entry, potentially declining by 70% to 80% over subsequent years as competition intensifies.

Will all semaglutide products go off-patent at the same time?

No. While the core molecule patents expire around 2029-2031, secondary patents covering specific formulations, delivery devices, or methods of use may expire later, potentially influencing the precise timing and availability of specific generic product types.

What is NDC 72578-0105?

NDC 72578-0105 is a National Drug Code identifier used in the United States to uniquely identify specific pharmaceutical products. For semaglutide, this NDC is associated with certain dosage strengths and forms of Novo Nordisk's branded products, serving as a reference point for drug product identification within the U.S. healthcare system.

How will Novo Nordisk respond to the loss of semaglutide market exclusivity?

Novo Nordisk is expected to focus on its pipeline of next-generation obesity and diabetes treatments, as well as potentially exploring life cycle management strategies for semaglutide, such as combination therapies or novel formulations, to mitigate the impact of generic competition.

Citations

[1] U.S. Patent No. 8,895,017. (2015). Semaglutide and analogues. United States Patent and Trademark Office.

[2] European Patent EP 2,614,580 B1. (2012). Semaglutide. European Patent Office.

[3] U.S. Food and Drug Administration. (n.d.). Generic Drugs Program. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drugs-program

[4] European Medicines Agency. (n.d.). Generic medicines. Retrieved from https://www.ema.europa.eu/en/human-regulatory/overview/generic-medicines

[5] Novo Nordisk. (2024). Annual Report 2023. Retrieved from https://www.novonordisk.com/investors/financial-reporting/annual-reports.html