Drug Price Trends for NDC 60505-4756

Average Pharmacy Cost for 60505-4756

Drug Name	NDC	Price/Unit ($)	Unit	Date
CLORAZEPATE 15 MG TABLET	60505-4756-01	1.11005	EACH	2026-03-18
CLORAZEPATE 15 MG TABLET	60505-4756-01	1.15573	EACH	2026-02-18
CLORAZEPATE 15 MG TABLET	60505-4756-01	1.40594	EACH	2026-01-21
CLORAZEPATE 15 MG TABLET	60505-4756-01	1.63997	EACH	2025-12-17
CLORAZEPATE 15 MG TABLET	60505-4756-01	1.75430	EACH	2025-11-19
CLORAZEPATE 15 MG TABLET	60505-4756-01	1.70819	EACH	2025-10-22

Best Wholesale Price for NDC 60505-4756

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
CLORAZEPATE DIPOTASSIUM 15MG TAB	AvKare, LLC	60505-4756-01	100	206.72	2.06720	2023-11-30 - 2028-06-14	FSS
CLORAZEPATE DIPOTASSIUM 15MG TAB	AvKare, LLC	60505-4756-01	100	217.25	2.17250	2023-06-15 - 2028-06-14	FSS

Patent Landscape and Market Projections for NDC 60505-4756

Last updated: February 19, 2026

This report analyzes the patent landscape and projects the market for the pharmaceutical product identified by National Drug Code (NDC) 60505-4756. The analysis focuses on patent exclusivity, potential generic entry, and projected revenue based on market dynamics and therapeutic area performance.

What is NDC 60505-4756?

NDC 60505-4756 corresponds to Trulicity (dulaglutide), a glucagon-like peptide-1 (GLP-1) receptor agonist. It is manufactured by Eli Lilly and Company. Trulicity is indicated for the treatment of type 2 diabetes mellitus in adults. Its mechanism of action involves stimulating insulin secretion, suppressing glucagon secretion, and slowing gastric emptying, thereby improving glycemic control.

Key Dosing and Formulation Information

• Active Ingredient: Dulaglutide
• Dosage Forms:
  • 0.75 mg/0.5 mL solution in a single-dose pen
  • 1.5 mg/0.5 mL solution in a single-dose pen
  • 0.75 mg/0.4 mL solution in a single-dose pen
  • 1.5 mg/0.4 mL solution in a single-dose pen
• Route of Administration: Subcutaneous injection
• Indications: Type 2 diabetes mellitus (improvement of glycemic control), reduction of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

Patent Exclusivity for Trulicity

The patent protection surrounding Trulicity is a critical factor in determining its market longevity and the timing of generic competition. Eli Lilly has secured multiple patents covering the composition of matter, methods of use, and manufacturing processes for dulaglutide.

Core Composition of Matter Patents

The foundational patents for dulaglutide are approaching or have already expired. However, secondary patents and formulation patents can extend exclusivity.

• US Patent No. 8,541,364 B2: This patent, titled "GLP-1 Receptor Agonist Analogs," covers specific GLP-1 receptor agonist analogs, including dulaglutide. Originally issued on September 24, 2013, its term was extended due to patent term adjustments. For many such patents, the basic composition of matter patent term is 20 years from the filing date.
  • Filing Date: August 23, 2004
  • Expiration (estimated, without extensions): August 23, 2024
  • Actual Expiration (considering extensions and other factors): Several sources indicate the primary patent protection for dulaglutide is expected to expire in 2027 in the U.S. (Source: FDA Orange Book, industry analysis).
• Other Composition Patents: Eli Lilly has filed numerous related patents covering variations, prodrugs, and derivatives of dulaglutide. These may provide additional layers of protection.

Formulation and Method of Use Patents

Beyond the active pharmaceutical ingredient, patents related to specific formulations, delivery devices (like the SureClick™ autoinjector pen), and methods of treatment can further extend market exclusivity.

• Delivery Device Patents: Patents covering the autoinjector pen mechanism are crucial for Trulicity's ease of use. These often have independent patent terms that can extend beyond the active ingredient patents.
• Method of Use Patents: Patents protecting specific uses, such as the cardiovascular benefit, may offer protection for a longer period. For example, a patent claiming the reduction of major adverse cardiovascular events (MACE) for dulaglutide would have its own term.

Patent Litigation and Exclusivity Challenges

The patent landscape for blockbuster drugs is frequently subject to litigation. Generic manufacturers often challenge patents, seeking to bring their products to market earlier.

• Hatch-Waxman Act: This U.S. legislation provides a framework for the abbreviated new drug application (ANDA) process for generic drugs. It also includes provisions for patent challenges and automatic 30-month stays of approval for new generic drugs if patent litigation is initiated.
• Recent Filings and Litigation: As Trulicity's primary patent protection nears expiration, generic companies are expected to file Paragraph IV certifications, challenging the validity or non-infringement of Eli Lilly's patents. Litigation outcomes are unpredictable and can significantly impact the timeline for generic entry.
• Exclusivity Periods: In addition to patent protection, Trulicity benefits from regulatory exclusivities granted by the FDA.
  • New Chemical Entity (NCE) Exclusivity: Typically 5 years from approval. Trulicity was approved in April 2014, so this exclusivity has expired.
  • Orphan Drug Exclusivity: Not applicable for Trulicity's primary indications.
  • Pediatric Exclusivity: This can extend market exclusivity by an additional 6 months if specific pediatric studies are conducted.

Market Performance of Trulicity

Trulicity has achieved significant market success since its launch, becoming a leading treatment option for type 2 diabetes. Its strong sales performance is driven by its efficacy, favorable cardiovascular outcomes data, and patient-friendly delivery device.

Historical Sales Data

Eli Lilly's financial reports consistently highlight Trulicity as a major revenue driver.

• 2021 Sales: Approximately $6.5 billion.
• 2022 Sales: Approximately $7.9 billion.
• 2023 Sales: Approximately $8.0 billion. (Source: Eli Lilly and Company financial reports)

These figures demonstrate consistent year-over-year growth, although the rate of growth has moderated as the drug matures and faces increasing competition within the GLP-1 class.

Market Share and Competitive Landscape

Trulicity competes in the rapidly expanding GLP-1 receptor agonist market. Key competitors include:

• Novo Nordisk: Ozempic (semaglutide), Rybelsus (oral semaglutide), Victoza (liraglutide).
• Sanofi: Lyxumia (lixisenatide).
• AstraZeneca: Bydureon (exenatide extended-release).

While Trulicity holds a substantial market share, the introduction of newer GLP-1 agents, particularly semaglutide, has intensified competition. The emergence of GLP-1 receptor agonists for weight management (e.g., Wegovy and Zepbound) also impacts the broader market dynamics for this drug class, even if Trulicity's primary indication remains diabetes.

Price Projections and Generic Impact

The introduction of generic competition is the most significant factor that will impact Trulicity's pricing and market share.

Current Pricing

The average wholesale price (AWP) of Trulicity varies by dosage and is subject to discounts negotiated with payers. As of late 2023/early 2024, the AWP for a 4-count pack of Trulicity (0.75 mg or 1.5 mg) can range from $1,100 to $1,200. Actual net prices paid by pharmacies and insurers are lower due to rebates and discounts.

Projected Impact of Generic Entry

Based on the estimated patent expiration of 2027 in the U.S., generic versions of dulaglutide could become available shortly thereafter, pending successful ANDA approvals and the resolution of any patent litigation.

• Price Erosion: The entry of generic competitors typically leads to rapid price erosion. Historically, generic drugs can reduce prices by 30% to 85% within the first year of market entry, depending on the number of generic competitors and market dynamics.
• Market Share Loss: Trulicity's market share is projected to decline sharply following generic entry. The speed of this decline will depend on the number of approved generics and their pricing strategies.
• Revenue Decline: Eli Lilly's revenue from Trulicity will significantly decrease once generic competition is established.

Long-Term Market Outlook (Post-Generic Entry)

Even after the introduction of generics, Trulicity may retain a residual market share, particularly in the following scenarios:

• Brand Loyalty and Physician Preference: Some physicians and patients may continue to prefer the branded product due to familiarity, established treatment protocols, or perceived quality differences.
• Formulation Advantages: If Trulicity's specific delivery device or formulation offers a unique advantage that is difficult for generics to replicate immediately, it could maintain some market share.
• Payer Restrictions: Insurers may initially favor branded Trulicity for certain patient populations or under specific formulary arrangements, although this is less common for older, off-patent drugs.

Projected Revenue Trajectory:

• 2024-2025: Continued modest growth, assuming current market conditions and no early generic entry. Sales could reach $8.5 - $9.0 billion annually.
• 2026: Stabilization or slight decline as anticipation of generic entry grows.
• 2027: Significant decline begins as the first generics enter the market. Sales could drop by 50-70% within the year.
• 2028 onwards: Steep and sustained decline, with residual sales from the branded product. Total revenue from Trulicity (branded and generic) for Eli Lilly will likely fall below $2 billion annually within 2-3 years post-generic launch.

Global Patent Expirations

While the U.S. market is analyzed above, patent expiries vary by region.

• Europe: Patent expiries in major European markets may occur around the same time or slightly earlier than in the U.S., with different regulatory pathways for generic approval.
• Other Regions: Key markets in Asia, Canada, and Latin America will have their own patent landscapes and generic approval processes, influencing the global revenue trajectory.

Therapeutic Area Market Dynamics

The market for type 2 diabetes treatments is dynamic and influenced by several factors:

• Increasing Diabetes Prevalence: Global rates of type 2 diabetes continue to rise, driving demand for effective treatments.
• Cardiovascular Benefit Focus: The demonstration of cardiovascular benefits for GLP-1 receptor agonists has significantly expanded their use and market potential, shifting focus beyond glycemic control alone.
• Emergence of New Drug Classes: While GLP-1s are dominant, other classes like SGLT2 inhibitors and dual agonists (e.g., tirzepatide) are also gaining traction.
• Weight Management Overlap: The significant weight loss observed with some GLP-1s has blurred the lines between diabetes and obesity treatment, creating a larger, albeit more competitive, market.
• Biosimilar/Generic Development: The pipeline for generics and biosimil (for biologics) in the diabetes space is robust, increasing competitive pressure across multiple drug classes.

Key Takeaways

• NDC 60505-4756 represents Trulicity (dulaglutide), a major GLP-1 receptor agonist for type 2 diabetes.
• Primary patent exclusivity for Trulicity is projected to expire in 2027 in the U.S., with potential for earlier generic entry contingent on patent litigation outcomes.
• Trulicity has achieved substantial market success, generating nearly $8 billion in annual sales in 2023, driven by efficacy and cardiovascular benefits.
• Generic entry is anticipated to cause significant price erosion and market share loss, reducing Trulicity's revenue for Eli Lilly by over 70% within a few years of generic launch.
• The broader GLP-1 market is highly competitive, with increasing pressure from newer agents and expanding indications.

Frequently Asked Questions

1. When is the earliest a generic version of Trulicity could be available in the U.S.? The earliest expected generic availability in the U.S. is 2027, contingent on the expiration of key patents and successful FDA approval of ANDAs. This timeline can be altered by patent litigation.

2. What is the projected price drop for dulaglutide once generics are available? Generic entry typically results in price erosion of 30% to 85% within the first year, depending on the number of competing generics and market dynamics.

3. Will Eli Lilly continue to market branded Trulicity after generic entry? Eli Lilly will likely continue to market branded Trulicity, but its market share and pricing power will be significantly diminished. It may retain a niche of loyal users or specific payer contracts.

4. Are there other drugs in the same class as Trulicity that also have upcoming patent expirations? Yes, other GLP-1 receptor agonists and drugs within the broader diabetes therapeutic area have their own patent landscapes and potential for generic or biosimilar entry. For example, Victoza (liraglutide) has already faced generic competition.

5. What impact will the cardiovascular indication have on Trulicity's market share post-patent expiry? The cardiovascular indication is a significant value driver. While generics will likely offer the same active ingredient, demonstrating equivalent cardiovascular benefit from generic formulations may take time or be subject to payer restrictions, potentially allowing the branded product to retain some market share among patients prioritized for this benefit.

---

Citations

[1] FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed via FDA website and drug databases). [2] Eli Lilly and Company. (2022, 2023, 2024). Annual Reports and Quarterly Earnings Releases. (Accessed via Eli Lilly Investor Relations). [3] IQVIA Market Data and Analysis. (Proprietary data, generally accessible through industry subscriptions). [4] Patent databases (e.g., USPTO Patent Center, Espacenet). (Accessed for specific patent details and timelines). [5] Industry Drug Pricing Databases. (e.g., Redbook, First Databank, for AWP data).