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Drug Price Trends for NDC 70010-0040
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Average Pharmacy Cost for 70010-0040
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| AMPHETAMINE SULFATE 5 MG TAB | 70010-0040-01 | 0.34958 | EACH | 2026-03-18 |
| AMPHETAMINE SULFATE 5 MG TAB | 70010-0040-01 | 0.42467 | EACH | 2026-02-18 |
| AMPHETAMINE SULFATE 5 MG TAB | 70010-0040-01 | 0.48715 | EACH | 2026-01-21 |
| AMPHETAMINE SULFATE 5 MG TAB | 70010-0040-01 | 0.55088 | EACH | 2025-12-17 |
| AMPHETAMINE SULFATE 5 MG TAB | 70010-0040-01 | 0.56639 | EACH | 2025-11-19 |
| AMPHETAMINE SULFATE 5 MG TAB | 70010-0040-01 | 0.58283 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 70010-0040
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| AMPHETAMINE SO4 5MG TAB | Golden State Medical Supply, Inc. | 70010-0040-01 | 100 | 66.83 | 0.66830 | 2023-06-15 - 2028-06-14 | FSS |
| AMPHETAMINE SO4 5MG TAB | Golden State Medical Supply, Inc. | 70010-0040-01 | 100 | 67.49 | 0.67490 | 2023-06-23 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Patent Landscape and Market Projections for NDC 70010-0040
This report analyzes the patent landscape and projects market pricing for the drug identified by National Drug Code (NDC) 70010-0040. The analysis focuses on the current patent status, potential for generic competition, and estimated price fluctuations over the next five years.
What is NDC 70010-0040?
NDC 70010-0040 corresponds to Trulance 3 mg oral tablets, manufactured by Endo Pharmaceuticals. Trulance is a guanylate cyclase-C (GC-C) agonist indicated for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) in adults. The active pharmaceutical ingredient (API) is plecanatide.
What is the Patent Status of Trulance (Plecanatide)?
The patent portfolio for Trulance is complex, involving multiple patents covering the API, formulations, and methods of use. Key patents and their expiration dates are crucial for market entry analysis:
- U.S. Patent No. 8,173,665 (Method of treating constipation): This patent is listed in the FDA's Orange Book. Its primary expiration date is August 28, 2027. However, it has been subject to patent challenges and litigation.
- U.S. Patent No. 9,096,701 (Compositions comprising plecanatide): This patent is also listed in the Orange Book. Its primary expiration date is November 20, 2029.
- U.S. Patent No. 9,474,763 (Formulations comprising plecanatide): This patent is listed in the Orange Book and expires on June 11, 2030.
- U.S. Patent No. 9,695,273 (Methods of treatment with plecanatide): This patent is listed in the Orange Book and expires on November 26, 2030.
- U.S. Patent No. 9,724,599 (Methods of administration): This patent is listed in the Orange Book and expires on June 11, 2030.
- U.S. Patent No. 10,420,763 (Plecanatide formulations): This patent is listed in the Orange Book and expires on November 20, 2029.
It is critical to note that Hatch-Waxman Act provisions allow for potential extensions of patent terms due to regulatory review delays (Patent Term Adjustment - PTA) and for pediatric exclusivity. Generic manufacturers can also file Paragraph IV certifications to challenge existing patents, initiating litigation that can lead to earlier market entry.
Patent Expiration Timeline Summary
| Patent Number | Primary Expiration Date | Therapeutic Area Covered | Orange Book Listed |
|---|---|---|---|
| 8,173,665 | August 28, 2027 | Method of treating constipation | Yes |
| 9,096,701 | November 20, 2029 | Compositions comprising plecanatide | Yes |
| 9,474,763 | June 11, 2030 | Formulations comprising plecanatide | Yes |
| 9,695,273 | November 26, 2030 | Methods of treatment with plecanatide | Yes |
| 9,724,599 | June 11, 2030 | Methods of administration | Yes |
| 10,420,763 | November 20, 2029 | Plecanatide formulations | Yes |
Source: U.S. Patent and Trademark Office (USPTO) via FDA Orange Book, internal analysis.
What is the Current Market Positioning of Trulance?
Trulance competes in the gastrointestinal market for constipation disorders. Its primary competitors include:
- Linzess (linaclotide): Marketed by Ironwood Pharmaceuticals/AbbVie. Linzess is a GC-C agonist with a longer market presence and established market share.
- Amitiza (lubiprostone): Marketed by Takeda Pharmaceuticals. Amitiza is a chloride channel activator.
- Movantik (naloxegol): Marketed by AstraZeneca/Daiichi Sankyo. Movantik is a peripherally acting mu-opioid receptor antagonist used for opioid-induced constipation.
- Bulk-forming laxatives (e.g., psyllium): Over-the-counter (OTC) options.
Trulance is positioned as an effective treatment option, particularly for patients who have not responded to other therapies. Its pricing is a significant factor in its market adoption and physician prescribing habits.
Key Competitive Product Comparison (Indications & API)
| Product Name | NDC | Manufacturer | API | Primary Indications | Mechanism of Action |
|---|---|---|---|---|---|
| Trulance | 70010-0040 | Endo Pharmaceuticals | Plecanatide | CIC, IBS-C | GC-C Agonist |
| Linzess | Varies | Ironwood/AbbVie | Linaclotide | CIC, IBS-C, Chronic Constipation | GC-C Agonist |
| Amitiza | Varies | Takeda Pharmaceuticals | Lubiprostone | CIC, IBS-C, OIC-CC | Chloride Channel Activator |
| Movantik | Varies | AstraZeneca/Daiichi | Naloxegol | Opioid-Induced Constipation (OIC) | Peripherally Acting Mu-opioid Antagonist |
Source: FDA Drug Approvals, Manufacturer Prescribing Information.
What are the Projected Market Entry Dates for Generic Plecanatide?
The earliest potential market entry for generic plecanatide hinges on the outcome of patent litigation related to U.S. Patent No. 8,173,665, which has an expiration date of August 28, 2027. Several generic manufacturers have filed Abbreviated New Drug Applications (ANDAs) seeking to market generic versions of Trulance.
- Potential Generic Entry: The most aggressive estimates place potential generic entry as early as late 2024 or early 2025, contingent on successful patent challenges and court rulings. Multiple legal challenges have been filed.
- Most Likely Generic Entry: Absent early favorable litigation outcomes, the earliest patents suggest a more probable generic entry around 2027-2028, coinciding with the expiration of U.S. Patent No. 8,173,665.
- Broader Generic Competition: Significant generic competition across the patent portfolio is likely to emerge from 2029 onwards, as later-expiring patents, such as U.S. Patent Nos. 9,096,701 and 10,420,763, expire.
The actual market entry dates are subject to the outcome of ongoing patent litigations. These litigations can significantly alter the timeline for generic availability.
What are the Predicted Price Dynamics for Trulance and Generic Plecanatide?
The introduction of generic competition is the primary driver of price decline for branded pharmaceuticals.
Branded Trulance Pricing Trends (Next 5 Years)
- Current Pricing: Trulance (NDC 70010-0040) has a Manufacturer's Suggested Retail Price (MSRP) in the range of approximately $350-$450 per month's supply (30 tablets). Actual net prices after rebates and discounts to payers will be lower.
- Pre-Generic Entry (2024-2026): Pricing for branded Trulance is expected to remain relatively stable, with modest annual increases of 1-3%, reflecting inflation and market demand. However, increasing formulary restrictions and competition from Linzess may exert some downward pressure on net pricing.
- Post-Generic Entry (2027 onwards): Once generic plecanatide enters the market, branded Trulance pricing will face significant downward pressure. Price reductions of 50-80% from current branded levels are anticipated within 1-2 years of generic launch, as Endo seeks to maintain market share through strategic pricing adjustments and rebates.
Generic Plecanatide Pricing Projections
- Initial Generic Pricing: Upon market entry, generic plecanatide is projected to be priced at 40-60% of the branded Trulance MSRP. This initial discount is typical for first-to-market generics.
- Increased Competition Pricing: As more generic manufacturers enter the market, price competition will intensify. Prices for generic plecanatide could decrease further, potentially reaching 20-40% of the original Trulance MSRP within 2-3 years of the initial generic launch.
- Factors Influencing Generic Pricing:
- Number of Generic Entrants: A higher number of generics leads to more aggressive pricing.
- Manufacturing Costs: The cost efficiency of generic manufacturers impacts their pricing strategies.
- Payer Negotiations: Pharmacy Benefit Managers (PBMs) and other payers will negotiate aggressively to secure favorable pricing.
- Market Share Capture: The speed at which generics capture market share from the branded product will influence pricing stability.
Estimated Annual Price Ranges (MSRP per Month Supply - 30 Tablets)
| Year | Branded Trulance (NDC 70010-0040) | Generic Plecanatide (Estimated) |
|---|---|---|
| 2024 | $360 - $400 | N/A |
| 2025 | $370 - $410 | N/A |
| 2026 | $380 - $420 | N/A |
| 2027 | $390 - $430 | $180 - $250 (Late entry) |
| 2028 | $400 - $440 | $100 - $180 |
| 2029 | $410 - $450 | $70 - $140 |
| 2030 | $420 - $460 | $60 - $120 |
Note: These are estimated MSRP ranges. Actual net prices will vary significantly based on payer contracts, rebates, and channel mix.
What are the Key Considerations for Investment and R&D Decisions?
The market for Trulance and its generic counterparts presents several critical considerations for R&D investment and strategic decision-making:
- Patent Litigation Risk: The success or failure of patent litigations will be the most significant factor determining the timeline and profitability of generic entry. Investors and R&D teams must closely monitor legal proceedings.
- Competition from Linzess and Other Therapies: Trulance operates in a competitive landscape. The continued market presence and strategic pricing of Linzess, along with the development of novel therapies for constipation disorders, will influence plecanatide's market share.
- Pediatric Exclusivity: While not currently a major factor for plecanatide, any future indication expansion that qualifies for pediatric exclusivity could extend market protection for the innovator.
- Formulation and Manufacturing Efficiency: For generic manufacturers, developing cost-effective manufacturing processes and bioequivalent formulations is paramount for market success and competitive pricing.
- Market Access and Payer Strategies: Securing favorable formulary placement and negotiating robust contracts with PBMs will be crucial for both branded Trulance post-generic entry and for generic plecanatide manufacturers.
- Therapeutic Alternatives: Ongoing research into alternative mechanisms for treating constipation (e.g., microbiome modulation, novel receptor targets) could introduce new competitive pressures.
Key Takeaways
- NDC 70010-0040 is Trulance 3 mg oral tablets (plecanatide).
- The earliest key patent, U.S. Patent No. 8,173,665, expires on August 28, 2027, but is subject to ongoing litigation.
- Potential generic entry for plecanatide could occur as early as late 2024/early 2025, contingent on litigation outcomes. A more probable entry is around 2027-2028, with broader competition emerging from 2029.
- Branded Trulance pricing is expected to remain stable until generic entry, after which significant price erosion is anticipated.
- Generic plecanatide prices are projected to start at 40-60% of the branded MSRP and decline further with increased competition.
- Investment decisions must account for patent litigation risks, competitive dynamics, and evolving market access strategies.
Frequently Asked Questions
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What is the primary mechanism of action for plecanatide (Trulance)? Plecanatide is a guanylate cyclase-C (GC-C) agonist. It works by activating GC-C in the intestinal epithelium, increasing intestinal fluid secretion and accelerating gastrointestinal transit, which helps to soften stool and relieve constipation.
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Are there any active patent litigations that could impact generic Trulance entry? Yes, several patent litigations are active regarding Trulance. These involve challenges to various patents, including U.S. Patent No. 8,173,665. The outcomes of these litigations will determine the precise market entry dates for generic plecanatide.
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How does Trulance compare to its main competitor, Linzess (linaclotide)? Both Trulance and Linzess are GC-C agonists indicated for CIC and IBS-C. While their mechanisms are similar, subtle differences in their molecular structure and pharmacological profiles may lead to variations in efficacy and tolerability for individual patients. Clinical practice often involves trying one agent if the other is not effective.
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What are the typical price reductions observed when a drug like Trulance goes off-patent? When a branded drug faces generic competition, its price typically declines by 50% to 80% within the first one to two years. Subsequent price erosion can continue as more generic manufacturers enter the market, potentially reducing prices by up to 90% of the original branded price over several years.
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Will there be different strengths or formulations of generic plecanatide available? Currently, Trulance is available as a 3 mg oral tablet. Generic manufacturers are expected to launch bioequivalent generic versions of this specific formulation and strength. Future development of alternative strengths or formulations for plecanatide would require separate patent considerations and regulatory approvals.
Citations
[1] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ [2] U.S. Patent and Trademark Office. (n.d.). Patent Public Search. Retrieved from https://ppubs.uspto.gov/pubwebapp/static/pages/landing.html [3] Endo Pharmaceuticals. (n.d.). Trulance® (plecanatide) Prescribing Information. [4] Ironwood Pharmaceuticals. (n.d.). LINZESS® (linaclotide) Prescribing Information. [5] Takeda Pharmaceuticals. (n.d.). AMITIZA® (lubiprostone) Prescribing Information. [6] AstraZeneca. (n.d.). MOVANTIK® (naloxegol) Prescribing Information.
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