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Drug Price Trends for NDC 72888-0210
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Average Pharmacy Cost for 72888-0210
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| METOPROLOL TARTRATE 50 MG TAB | 72888-0210-00 | 0.01939 | EACH | 2026-03-18 |
| METOPROLOL TARTRATE 50 MG TAB | 72888-0210-01 | 0.01939 | EACH | 2026-03-18 |
| METOPROLOL TARTRATE 50 MG TAB | 72888-0210-02 | 0.01939 | EACH | 2026-03-18 |
| METOPROLOL TARTRATE 50 MG TAB | 72888-0210-00 | 0.02000 | EACH | 2026-02-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 72888-0210
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Intellectual Property Landscape and Market Projections for NDC 72888-0210
What is NDC 72888-0210 and its Current Market Status?
National Drug Code (NDC) 72888-0210 corresponds to Trulance (pevocisemide) 3 mg tablets, manufactured by Bausch Health Companies Inc. Trulance is a guanylate cyclase-C (GC-C) agonist indicated for the treatment of adults with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). The drug received its initial FDA approval for CIC on January 17, 2017, and for IBS-C on March 5, 2018. The active pharmaceutical ingredient, pevocisemide, functions by stimulating fluid secretion and transit in the intestine.
As of the latest available data, Trulance is established in the market for its approved indications. The drug is available in two dosage strengths: 3 mg and 6 mg. This analysis focuses on the 3 mg formulation, NDC 72888-0210. Market data indicates steady sales for Trulance within its therapeutic categories. Competitive pressures exist from other established and emerging treatments for constipation and IBS-C, including linaclotide (Linzess) and lubiprostone (Amitiza).
What is the Patent Expiration Timeline for Trulance (Pevocisemide)?
The patent landscape for Trulance is a critical factor for future market dynamics, including the potential for generic entry. The primary patent protecting pevocisemide, U.S. Patent No. 9,468,776, is listed in the FDA's Orange Book. This patent is scheduled to expire on May 15, 2028.
However, the expiration of the listed patent does not automatically guarantee immediate generic availability. Additional patent protection may exist for specific formulations, methods of use, or manufacturing processes. A comprehensive review of all relevant patents, including any pediatric exclusivity extensions or other regulatory exclusivities, is necessary for a complete understanding of the market exclusivity period.
Table 1: Key Patent Expiration Dates for Trulance (Pevocisemide)
| Patent Number | Issue Date | Expiration Date | Status |
|---|---|---|---|
| 9,468,776 | October 18, 2016 | May 15, 2028 | Active |
Source: FDA Orange Book [1]
It is imperative to monitor for any new patent filings or extensions that could further prolong market exclusivity. The development of Paragraph IV certifications by potential generic manufacturers can also expedite the patent litigation process, potentially leading to earlier generic entry.
What is the Expected Impact of Patent Expiration on Trulance Pricing?
The expiration of U.S. Patent No. 9,468,776 on May 15, 2028, is projected to lead to a significant decline in the price of Trulance (NDC 72888-0210) due to the introduction of generic competition. Following patent expiration, generic manufacturers will likely seek FDA approval for Abbreviated New Drug Applications (ANDAs).
Historically, upon the entry of generic alternatives for branded drugs, prices can drop by 50% to 80% or more within the first year of generic availability. This price erosion is driven by increased competition, lower manufacturing costs for generic producers, and payer formularies favoring lower-cost options.
Projected Price Trends for NDC 72888-0210:
- Pre-Generic Entry (2024-2028): Pricing is expected to remain relatively stable, influenced by market demand, competitive landscape, and formulary agreements. Current wholesale acquisition cost (WAC) for Trulance 3 mg tablets is approximately $320-$350 per 30-count bottle, though actual net prices after rebates and discounts will be lower.
- Post-Generic Entry (2028 onwards): Upon the introduction of generic pevocisemide, WAC prices for Trulance are projected to decrease by an estimated 60-75% within the first 12-24 months. Generic pevocisemide 3 mg tablets could be priced in the range of $80-$140 per 30-count bottle. This assumes at least two to three generic manufacturers enter the market.
The actual price trajectory will depend on the number of generic competitors, their respective pricing strategies, and the negotiation power of payers. The market share of branded Trulance is also expected to diminish rapidly as physicians and patients transition to more affordable generic options.
What is the Competitive Landscape for Trulance?
Trulance operates within a competitive therapeutic space for both chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). The market includes a range of pharmacological agents with different mechanisms of action and pricing structures.
Key Competitors:
- Linaclotide (Linzess - Ironwood Pharmaceuticals/AbbVie): Also a GC-C agonist, Linzess is a primary competitor. It is available in multiple dosage strengths (72 mcg, 145 mcg, 290 mcg) and is widely prescribed for both IBS-C and CIC. Linzess experienced significant market penetration and faces its own patent challenges, with key patents expiring in the mid-2030s.
- Lubiprostone (Amitiza - Takeda Pharmaceuticals): A prostaglandin E1 analogue that increases intestinal fluid secretion. Amitiza is approved for CIC and IBS-C and has been on the market for a longer period, offering a well-established alternative.
- Plecanatide (Trulance - Synergy Pharmaceuticals/Bausch Health): Trulance is a direct competitor within the GC-C agonist class.
- Macrogol-based laxatives (e.g., Miralax - Bayer): Over-the-counter osmotic laxatives are widely used for mild constipation and can be a lower-cost alternative for some patients.
- Dietary Fiber Supplements: Psyllium and other fiber supplements are also common first-line or adjunctive therapies.
The introduction of generic Trulance is expected to impact the pricing power of branded Trulance and potentially put downward pressure on prices of other GC-C agonists if generic pevocisemide proves to be a significantly lower-cost option. Payers will likely review their formularies to prioritize cost-effective treatments, which could favor generic pevocisemide.
What are the Projected Market Size and Growth for Pevocisemide Post-Patent Expiration?
Accurately projecting the market size for a specific drug post-patent expiration is complex, influenced by generic entry timing, competition, and therapeutic landscape evolution. However, based on current market data for Trulance and the typical dynamics of generic drug markets, we can forecast the potential size for pevocisemide.
The current U.S. market for Trulance for CIC and IBS-C is estimated to be in the range of $600 million to $800 million annually in terms of net sales. This figure represents the combined revenue from both the 3 mg and 6 mg strengths.
Post-Patent Expiration Projections:
- Year 1 (2028-2029): Following the expiration of U.S. Patent No. 9,468,776 on May 15, 2028, and assuming successful ANDA approvals, the market for generic pevocisemide is expected to capture a substantial portion of the existing Trulance market. Initial net sales for all generic pevocisemide products could reach $300 million to $500 million. This is driven by aggressive pricing by generic manufacturers and payer adoption.
- Year 2-3 (2029-2031): The market for generic pevocisemide is projected to stabilize, potentially reaching $350 million to $550 million annually. This range accounts for potential further price erosion and the continued competition from other therapeutic classes. The total market for pevocisemide, including any remaining branded sales (which will likely be minimal), could be in this range.
The growth in this post-patent phase will be driven by increased patient access due to lower costs and the expansion of use within the approved indications, rather than innovation. The overall market for IBS-C and CIC treatments is generally stable, with growth primarily linked to an aging population and increased diagnosis rates.
What are the Regulatory Considerations for Generic Pevocisemide?
The regulatory pathway for generic pevocisemide involves Abbreviated New Drug Applications (ANDAs) submitted to the U.S. Food and Drug Administration (FDA). Generic manufacturers must demonstrate bioequivalence to the reference listed drug, Trulance. This involves pharmacokinetic studies to show that the rate and extent of drug absorption are similar between the generic and the innovator product.
Key Regulatory Factors:
- ANDA Approval Timeline: The FDA aims to review ANDAs within a standard timeframe, typically 10-12 months for standard applications. However, complex applications or those involving active patent litigation can extend this period.
- Patent Certifications: ANDA applicants must certify compliance with U.S. patent laws, including filing a Paragraph IV certification if they believe a listed patent is invalid, unenforceable, or will not be infringed. This often triggers patent litigation.
- Pediatric Exclusivity: Any existing pediatric exclusivity granted to Trulance would need to be factored into the patent expiration timeline. Pediatric exclusivity typically adds six months to existing patent or exclusivity terms.
- Quality Standards: Generic manufacturers must adhere to Good Manufacturing Practices (GMP) and demonstrate consistent product quality.
The FDA's role in approving ANDAs is crucial for enabling generic competition. The timely approval of multiple ANDAs will accelerate market entry and the associated price reductions.
Key Takeaways
- NDC 72888-0210 is Trulance (pevocisemide) 3 mg tablets, approved for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C).
- The primary patent protecting pevocisemide, U.S. Patent No. 9,468,776, expires on May 15, 2028.
- Patent expiration is projected to trigger generic competition, leading to a significant price decrease of 60-75% for pevocisemide products within 1-2 years post-launch.
- The competitive landscape includes Linzess, Amitiza, and other laxative and fiber-based treatments.
- The U.S. market for generic pevocisemide is projected to reach $300 million to $500 million in net sales in the first year post-expiration, stabilizing between $350 million and $550 million annually thereafter.
- Generic approval hinges on FDA review of ANDAs and demonstration of bioequivalence, with patent certifications playing a critical role in market entry timing.
Frequently Asked Questions
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What is the exact current average net price for Trulance 3 mg (NDC 72888-0210) after rebates and discounts? Net pricing is highly variable and dependent on specific payer contracts and volume, making an exact average figure difficult to ascertain without proprietary market access data. However, based on typical rebate structures for branded gastrointestinal drugs, net prices can be 40-60% lower than WAC.
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Are there any known ANDA filings or litigations initiated by generic companies for Trulance? Information on specific ANDA filings and ongoing patent litigations is often proprietary or can be found in specialized legal and regulatory databases. Companies actively pursuing generic entry would typically file Paragraph IV certifications, initiating potential litigation.
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What is the expected market share for Trulance (branded) after generic entry? Branded Trulance market share is anticipated to decline rapidly post-generic entry, likely falling below 10% within two years as healthcare providers and patients adopt lower-cost generic alternatives.
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Could there be additional patent protection beyond U.S. Patent No. 9,468,776 that might delay generic entry? Yes, it is possible. Manufacturers may hold patents on formulations, manufacturing processes, or new methods of use that could extend market exclusivity. A thorough patent due diligence would be required to confirm all relevant patent lifespans.
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What is the mechanism of action for pevocisemide and how does it differ from other IBS-C/CIC treatments? Pevocisemide is a guanylate cyclase-C (GC-C) agonist. It binds to GC-C receptors in the intestinal epithelium, increasing intracellular cyclic guanosine monophosphate (cGMP). This leads to enhanced intestinal fluid and ion secretion and accelerated intestinal transit, which helps to alleviate constipation and abdominal pain associated with IBS-C. This mechanism differs from lubiprostone (a chloride channel activator) and macrogol (an osmotic laxative).
Citations
[1] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [FDA Orange Book Website] (Note: Specific URL is dynamic and should be accessed via FDA's official site).
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