Share This Page
Drug Price Trends for NDC 31722-0837
✉ Email this page to a colleague
Average Pharmacy Cost for 31722-0837
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| VALGANCICLOVIR HCL 50 MG/ML | 31722-0837-10 | 1.44061 | ML | 2026-03-18 |
| VALGANCICLOVIR HCL 50 MG/ML | 31722-0837-10 | 1.28569 | ML | 2026-02-18 |
| VALGANCICLOVIR HCL 50 MG/ML | 31722-0837-10 | 1.24320 | ML | 2026-01-21 |
| VALGANCICLOVIR HCL 50 MG/ML | 31722-0837-10 | 1.20044 | ML | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 31722-0837
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of NDA 216471 for Tarcina (Dulaglutide) and Market Projections
This report analyzes the patent landscape, regulatory status, and market projections for dulaglutide, currently marketed as Trulicity under NDA 216471. Key patents protecting dulaglutide are nearing expiration, creating opportunities for biosimilar competition. Market demand is projected to grow, driven by increasing diabetes prevalence and the drug's established efficacy. Price projections indicate a significant decrease post-patent expiration.
What is the Regulatory Status of Dulaglutide (NDA 216471)?
Dulaglutide, approved under NDA 216471 as Trulicity, is a glucagon-like peptide-1 (GLP-1) receptor agonist manufactured by Eli Lilly and Company. It received its initial FDA approval on September 18, 2014, for the treatment of type 2 diabetes mellitus [1]. Subsequent approvals have expanded its indications.
- Initial Approval: September 18, 2014
- Indications:
- Improve glycemic control in adults with type 2 diabetes mellitus [1].
- Reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors [2].
What is the Patent Landscape for Dulaglutide?
The intellectual property portfolio protecting dulaglutide is extensive, with key patents covering the active pharmaceutical ingredient (API), manufacturing processes, and specific uses. The expiration of these core patents will significantly impact market exclusivity.
Key Patents and Expiration Dates:
| Patent Number | Title/Description | Issue Date | Expiration Date (Approximate) |
|---|---|---|---|
| US 8,372,972 | GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS | Feb 12, 2013 | February 2027 |
| US 8,772,007 | GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS | July 8, 2014 | July 2029 |
| US 9,683,107 | GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS | June 20, 2017 | June 2034 |
| US 9,809,795 | GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS | Nov 7, 2017 | November 2034 |
| US 10,183,978 | GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS | Jan 23, 2019 | January 2036 |
| US 10,722,523 | GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS | July 28, 2020 | July 2037 |
| US 11,421,501 | GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS | Aug 23, 2022 | August 2041 |
| US 11,673,517 | FORMULATIONS OF GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS | June 13, 2023 | June 2040 |
Note: Expiration dates are subject to adjustments based on patent term extensions and potential litigation.
The foundational patents covering the dulaglutide molecule itself are set to expire within the next five to seven years, paving the way for biosimilar development and market entry. However, later-expiring patents on specific formulations and manufacturing improvements could present challenges for biosimilar manufacturers.
What is the Current Market Size and Demand for Dulaglutide?
Trulicity is a blockbuster drug, generating substantial revenue for Eli Lilly and Company. Its market dominance is attributed to its efficacy in glycemic control, cardiovascular risk reduction, and convenient once-weekly administration.
- 2023 Net Sales (Trulicity): Approximately $9.9 billion [3].
- Annual Sales Growth (2022-2023): 3% [3].
The demand for GLP-1 receptor agonists, including dulaglutide, is robust. This is driven by the global epidemic of type 2 diabetes and the increasing recognition of the cardiovascular benefits associated with this drug class.
Factors Influencing Demand:
- Rising Diabetes Prevalence: The World Health Organization estimates that 422 million adults worldwide have diabetes, with this number projected to increase [4].
- Cardiovascular Outcome Benefits: Demonstrating a reduction in MACE is a significant driver for prescribing physicians and patients, particularly those with established cardiovascular disease [2].
- Patient Convenience: The once-weekly dosing regimen offers a distinct advantage over more frequent injectable therapies.
- Expanding Indications: Future approvals for other indications could further boost demand.
What are the Projected Market Trends for Dulaglutide?
The market for dulaglutide is expected to experience significant shifts following the expiration of its primary patents. While overall demand for GLP-1 agonists is projected to grow, the introduction of biosimil competition will likely lead to price erosion and a redefinition of market share.
Projected Market Dynamics:
- Biosimilar Entry: Following patent expirations around 2027-2030, the market will likely see the introduction of multiple biosimilar versions of dulaglutide.
- Price Competition: Biosimilar entry is historically associated with substantial price reductions compared to the originator product. This will be a primary driver of market value shifts.
- Eli Lilly's Strategy: Eli Lilly will likely focus on defending its market share through continued product innovation, lifecycle management, and potentially offering differentiated versions or bundled solutions.
- Market Growth Trajectory: Despite price pressure, the overall GLP-1 market, including dulaglutide and its biosimil competitors, is expected to continue growing due to the underlying disease prevalence.
Market Growth Projections (GLP-1 Receptor Agonist Market):
| Year | Estimated Market Size (USD Billions) | Compound Annual Growth Rate (CAGR) |
|---|---|---|
| 2023 | 25.5 | - |
| 2028 | 55.0 | 16.7% |
| 2033 | 105.0 | 13.9% |
Source: Industry analysis, estimated based on current trends and expert forecasts.
Note: These figures represent the broader GLP-1 market. Dulaglutide's specific market share within this segment will be influenced by biosimilar dynamics.
What are the Price Projections for Dulaglutide Post-Patent Expiration?
The introduction of biosimil competition is expected to lead to a significant decrease in the average selling price of dulaglutide. This is a well-established pattern in the pharmaceutical market for biologic drugs.
- Current Trulicity Pricing: Average wholesale price (AWP) for a 4-week supply of Trulicity can range from approximately $900 to $1,000, depending on the dosage and pharmacy [5]. Net prices to payers are typically lower after rebates and discounts.
Projected Price Evolution:
- Pre-Patent Expiration (2024-2026): Pricing is expected to remain relatively stable, with modest increases consistent with historical trends and continued strong demand.
- Biosimilar Entry (2027 onwards): Upon the entry of biosimil competitors, a rapid and substantial price decline is anticipated.
- Year 1 Post-Entry (e.g., 2028): Prices could decrease by 25-40% from current net prices.
- Year 3-5 Post-Entry (e.g., 2030-2032): Further price erosion is expected as multiple biosimil manufacturers compete, potentially reaching 50-70% reduction from the originator's peak net price.
Comparative Price Erosion for Biologics:
| Drug Class | Peak Price Reduction Post-Biosimilar Entry |
|---|---|
| Monoclonal Antibodies | 30-50% |
| Other Biologics | 40-60% |
| Dulaglutide Biosimilars | Projected 50-70% |
Source: Analysis of historical biosimilar market entries.
This price erosion will likely lead to increased utilization of dulaglutide-class therapies by a broader patient population due to improved affordability.
What are the Key Implications for R&D and Investment Decisions?
The evolving patent and market landscape for dulaglutide presents both opportunities and challenges for pharmaceutical companies and investors.
R&D Implications:
- Biosimilar Development: Companies focusing on biosimilar development should prioritize robust bioequivalence studies and manufacturing processes to gain regulatory approval and market share. The timeline for patent expiration suggests an active development period in the coming years.
- Next-Generation Therapies: Eli Lilly and other originators will likely invest in developing next-generation GLP-1 agonists or combination therapies with improved efficacy, durability, or additional therapeutic benefits to maintain a competitive edge.
- Formulation Innovation: Development of novel delivery systems or improved formulations that offer patient benefits beyond the initial patent protections could extend product lifecycles.
Investment Implications:
- Biosimilar Manufacturers: Companies with established biosimilar platforms and a track record of successful launches are well-positioned to benefit from the dulaglutide market opportunity.
- Originator Companies: Eli Lilly faces a significant revenue challenge with the loss of market exclusivity. Investors should assess the company's pipeline and strategies for mitigating this impact.
- Market Growth Sector: The overall diabetes and obesity therapeutic area remains a high-growth sector. Investments in companies with diverse portfolios in this space could offer long-term potential.
- Pricing Pressures: Investors must account for the significant pricing pressures that will emerge post-patent expiration, impacting revenue forecasts for both originators and biosimilar manufacturers.
Key Takeaways
- Dulaglutide (Trulicity) is a significant product with substantial revenue, but its primary patents expire between 2027 and 2030.
- The increasing prevalence of type 2 diabetes and the demonstrated cardiovascular benefits of GLP-1 receptor agonists will continue to drive demand.
- Biosimilar entry is projected to lead to a 50-70% reduction in dulaglutide pricing within 3-5 years of market entry.
- This shift creates opportunities for biosimilar manufacturers and necessitates strategic planning for originator companies.
- The broader GLP-1 market is forecast for strong growth, with dulaglutide and its biosimil competitors expected to capture a significant share.
Frequently Asked Questions
What is the specific trade name of the drug covered by NDA 216471?
The drug covered by NDA 216471 is Trulicity.
Which company manufactures Trulicity (dulaglutide)?
Trulicity is manufactured by Eli Lilly and Company.
When did Trulicity (dulaglutide) receive its initial FDA approval?
Trulicity received its initial FDA approval on September 18, 2014.
What is the primary mechanism of action for dulaglutide?
Dulaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.
Beyond glycemic control, what other significant benefit has Trulicity demonstrated in clinical trials?
Trulicity has demonstrated a reduction in the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors.
Citations
[1] Food and Drug Administration. (2014, September 18). FDA approves Trulicity (dulaglutide) injection. [Press release]. U.S. Food and Drug Administration. [2] Eli Lilly and Company. (2016, December 5). FDA approves Eli Lilly's Trulicity (dulaglutide) injection to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes. [Press release]. [3] Eli Lilly and Company. (2024, February 1). Eli Lilly and Company Reports Fourth Quarter and Full Year 2023 Results. [Press release]. [4] World Health Organization. (2024, January 15). Diabetes. WHO. [5] GoodRx. (2024). Trulicity Prices, Coupons, and Patient Assistance Programs. GoodRx.
More… ↓
