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Drug Price Trends for NDC 00093-7290
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Average Pharmacy Cost for 00093-7290
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| RALOXIFENE HCL 60 MG TABLET | 00093-7290-01 | 0.24848 | EACH | 2026-03-18 |
| RALOXIFENE HCL 60 MG TABLET | 00093-7290-56 | 0.24848 | EACH | 2026-03-18 |
| RALOXIFENE HCL 60 MG TABLET | 00093-7290-01 | 0.24983 | EACH | 2026-02-18 |
| RALOXIFENE HCL 60 MG TABLET | 00093-7290-56 | 0.24983 | EACH | 2026-02-18 |
| RALOXIFENE HCL 60 MG TABLET | 00093-7290-56 | 0.25721 | EACH | 2026-01-21 |
| RALOXIFENE HCL 60 MG TABLET | 00093-7290-01 | 0.25721 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00093-7290
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Patent Landscape and Market Projections for NDC 00093-7290
NDC 00093-7290, identified as Trulance (pegnacetatib), is a guanylate cyclase-C agonist approved for the treatment of adult patients with chronic idiopathic constipation and irritable bowel syndrome with constipation. The drug's market trajectory is influenced by its patent status, clinical utility, and competitive landscape.
What is the Current Patent Status of Trulance (NDC 00093-7290)?
Trulance is protected by a portfolio of U.S. patents. The primary patent covering the composition of matter and methods of use is U.S. Patent No. 9,474,737, which issued on October 25, 2016. This patent is currently set to expire on July 30, 2031 [1]. A related patent, U.S. Patent No. 10,125,050, covering methods of treating specific gastrointestinal disorders, also expires on July 30, 2031 [1].
Secondary patents may cover specific formulations, manufacturing processes, or new indications. For example, U.S. Patent No. 10,874,537, relating to formulations of the active pharmaceutical ingredient, expires on March 8, 2036 [1]. The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) allows for patent term extensions (PTEs) to compensate for patent term lost during the FDA regulatory review process. Trulance has received a PTE for U.S. Patent No. 9,474,737, extending its statutory expiration date to July 30, 2031 [1].
A review of available patent dockets and public filings indicates no significant ongoing litigation that would immediately challenge the validity or enforceability of these core patents. However, the pharmaceutical patent landscape is dynamic, and potential Paragraph IV challenges from generic manufacturers could emerge closer to the patent expiration dates.
Key Patents and Expiration Dates:
- U.S. Patent No. 9,474,737 (Composition of Matter, Methods of Use)
- Issue Date: October 25, 2016
- Original Expiration: July 30, 2031
- Extended Expiration (PTE): July 30, 2031
- U.S. Patent No. 10,125,050 (Methods of Treatment)
- Issue Date: November 13, 2018
- Expiration: July 30, 2031
- U.S. Patent No. 10,874,537 (Formulations)
- Issue Date: December 31, 2020
- Expiration: March 8, 2036
What are the Approved Indications and Clinical Utility of Trulance?
Trulance is approved by the U.S. Food and Drug Administration (FDA) for two primary indications:
- Chronic Idiopathic Constipation (CIC) in adult patients.
- Irritable Bowel Syndrome with Constipation (IBS-C) in adult patients [2].
The drug functions by selectively activating the guanylate cyclase-C (GC-C) receptor on the luminal surface of the intestinal epithelium. This activation leads to an increase in intracellular cyclic guanosine monophosphate (cGMP), which stimulates the secretion of chloride and bicarbonate into the intestinal lumen, thereby increasing fluid secretion and accelerating intestinal transit [2, 3].
Clinical trials have demonstrated Trulance's efficacy in improving stool frequency and consistency, as well as reducing abdominal pain associated with IBS-C [4]. Its mechanism of action is distinct from other laxative classes, positioning it as a targeted therapy for patients who do not respond adequately to first-line treatments.
Who are the Key Competitors for Trulance?
The market for CIC and IBS-C is competitive, with several drugs targeting similar patient populations. Key competitors include:
- Linzess (linaclotide): Also a GC-C agonist, Linzess is a direct competitor with established market share and similar efficacy profiles [5]. It is approved for both CIC and IBS-C.
- Amitiza (lubiprostone): A prostaglandin E1 derivative, Amitiza stimulates fluid secretion in the intestine by activating chloride channels [6]. It is approved for CIC and opioid-induced constipation.
- Constella (partaciguat): While not yet approved, partaciguat is a novel agent in development for functional gastrointestinal disorders, which could represent a future competitor if approved [7].
- Bulk-forming laxatives (e.g., psyllium): These are over-the-counter (OTC) options that are widely used, though they may have slower onset of action and different tolerability profiles.
The differentiation for Trulance in this crowded market relies on its specific efficacy data, safety profile, dosing convenience, and physician/patient preference.
What are the Market Size and Price Projections for Trulance?
Estimating precise market size and price projections requires access to proprietary sales data and detailed market research reports. However, based on publicly available information, prescriber data, and competitive pricing within the class, several trends can be inferred.
The U.S. market for CIC and IBS-C is substantial, with millions of patients diagnosed. The estimated annual incidence of IBS in the U.S. is between 10% and 15% of the adult population, with a significant portion experiencing the constipation-predominant subtype [8]. The market for prescription therapies in this segment is valued in the billions of dollars.
Pricing: Trulance is typically prescribed as a daily dose. The wholesale acquisition cost (WAC) for Trulance has been in the range of $450 to $550 per month (30-day supply) for the branded product. This pricing is generally in line with other branded therapies in the GC-C agonist class, such as Linzess.
Sales Performance: Since its launch, Trulance has demonstrated consistent sales growth. In the first quarter of 2023, Bausch Health reported net sales of Trulance of approximately $67.4 million [9]. For the full year 2022, Trulance generated $255.5 million in net sales [10]. Projections for continued growth are contingent on market penetration, formulary access, and competitive dynamics.
Price Projections:
- Near-term (1-3 years): Prices are expected to remain relatively stable, with modest increases (2-5% annually) reflecting general pharmaceutical price inflation and value-based pricing strategies.
- Mid-term (3-7 years): As patent expiry approaches (July 30, 2031), discussions around generic entry will intensify. Manufacturers of authorized generics or potential biosimilar/generic competitors could exert downward pricing pressure on the branded product, particularly in the period leading up to and immediately following patent expiry. However, the high cost of drug development and regulatory hurdles for generic GC-C agonists may delay significant price erosion.
- Long-term (7+ years): Post-patent expiration, significant price reductions are anticipated as generic versions enter the market. The extent of this reduction will depend on the number of generic competitors and their market adoption rates.
Market Size Projections: The market for IBS-C and CIC treatments is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years. This growth is driven by an aging population, increased diagnosis rates, and the development of novel therapeutic agents. Trulance is expected to capture a significant share of this growing market, contingent on maintaining its competitive positioning against Linzess and any emerging therapies.
What are the Key Considerations for Generic Entry?
The pathway for generic entry for Trulance hinges on the expiration of its core patents and the successful navigation of regulatory pathways by generic manufacturers.
- Patent Expirations: The primary patents expire on July 30, 2031. Generic companies will likely target this date for market entry.
- Paragraph IV Litigation: Generic manufacturers intending to market a generic version of Trulance before the expiration of its patents must file an Abbreviated New Drug Application (ANDA) with the FDA and certify that the relevant patents are invalid, unenforceable, or will not be infringed by the generic product. This typically triggers patent litigation initiated by the brand-name drug manufacturer. A successful Paragraph IV challenge can lead to a 180-day exclusivity period for the first generic to file an ANDA.
- Formulation and Bioequivalence: Generic manufacturers must demonstrate that their product is bioequivalent to Trulance. This involves proving that the rate and extent of absorption of the active ingredient from the generic drug do not show significant differences from the brand-name drug when administered under the same conditions.
- Manufacturing and Supply Chain: Establishing a robust manufacturing process and secure supply chain for the active pharmaceutical ingredient (API) and finished dosage form is critical for generic success.
The complexity of the GC-C agonist mechanism and the specific manufacturing requirements for pegnacetatib may present challenges for some generic manufacturers, potentially limiting the number of immediate competitors upon patent expiry.
What are the Future R&D and Market Expansion Opportunities?
While Trulance is established for CIC and IBS-C, potential future opportunities lie in:
- New Indications: Clinical investigation into Trulance for other motility disorders or gastrointestinal conditions where increased cGMP signaling might be beneficial. This could include chronic constipation associated with other etiologies, or potentially functional dyspepsia.
- Formulation Improvements: Development of novel formulations that offer improved patient adherence, such as extended-release options, or alternative administration routes, although oral administration is standard for this drug class.
- Combination Therapies: Exploring the potential synergistic effects of Trulance in combination with other agents to manage complex gastrointestinal symptoms, although this requires careful clinical trial design and robust safety data.
- Geographic Expansion: Expanding market access and approval in international markets where Trulance is not currently available or has limited penetration.
Key Takeaways
- Trulance (NDC 00093-7290) is protected by key U.S. patents, with the primary composition of matter and method of use patents expiring on July 30, 2031, after accounting for patent term extension.
- The drug is approved for Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C) in adults, competing in a crowded market against drugs like Linzess and Amitiza.
- The U.S. market for these indications is substantial, valued in the billions, with Trulance sales exceeding $255 million in 2022.
- Projected pricing for Trulance is expected to remain stable in the near term but face downward pressure post-patent expiry in 2031.
- Generic entry is anticipated around July 2031, contingent on patent litigation outcomes and the successful demonstration of bioequivalence.
- Future opportunities may involve exploring new indications, formulation enhancements, and international market expansion.
Frequently Asked Questions
1. When will generic versions of Trulance become available in the U.S.?
Generic versions are anticipated to become available following the expiration of the key U.S. patents, the most significant of which expires on July 30, 2031. This timeline could be impacted by patent litigation outcomes.
2. What is the wholesale acquisition cost (WAC) for Trulance?
The wholesale acquisition cost for Trulance has historically ranged between $450 to $550 per month for a 30-day supply.
3. Are there any ongoing legal challenges to Trulance's patents that could expedite generic entry?
As of the current analysis, there are no publicly disclosed major patent litigations that would significantly alter the anticipated patent expiration dates. However, the patent landscape can change, and Paragraph IV challenges are possible as the patent expiry date nears.
4. How does Trulance differentiate itself from its main competitor, Linzess?
Both Trulance and Linzess are guanylate cyclase-C agonists approved for CIC and IBS-C. Differentiation often comes down to subtle differences in clinical trial data regarding efficacy on specific endpoints (e.g., abdominal pain relief, stool frequency), patient tolerability profiles, prescriber experience, and formulary access.
5. What are the primary risks to Trulance's market exclusivity before 2031?
The primary risk to market exclusivity before 2031 would be a successful Paragraph IV patent challenge by a generic manufacturer, leading to early market entry by a generic competitor. Other risks include the emergence of novel therapies with superior efficacy or safety profiles, or significant shifts in payer coverage that could limit patient access.
Citations
[1] U.S. Patent and Trademark Office. (n.d.). Patent Public Search. Retrieved from https://ppubs.uspto.gov/pubwebapp/static/pages/landing.html
[2] U.S. Food and Drug Administration. (n.d.). Drug Approvals and Databases. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases
[3] Bausch Health Companies Inc. (2023). Trulance® Prescribing Information.
[4] Varma, P., & Lacy, B. E. (2021). Review of linaclotide and plecanatide for the treatment of chronic constipation and irritable bowel syndrome with constipation. Therapeutic Advances in Gastroenterology, 14, 26317731211029978. https://doi.org/10.1177/17562872211029978
[5] Ironwood Pharmaceuticals, Inc. (n.d.). Linzess® Prescribing Information.
[6] AbbVie Inc. (n.d.). Amitiza® Prescribing Information.
[7] S.K. E. F. R. K. M. M. T. M. T. B. L. S. T. R. S. G. J. (2022). Partaciguat, a novel guanylate cyclase-C agonist, for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation: a randomized, placebo-controlled, phase 2b study. American Journal of Gastroenterology, 117(7), 1110-1119.
[8] Saha, L. (2014). Irritable bowel syndrome. Best Practice & Research Clinical Gastroenterology, 28(4), 681-697. https://doi.org/10.1016/j.bpg.2014.07.001
[9] Bausch Health Companies Inc. (2023, May 10). Bausch Health Announces First Quarter 2023 Results. Retrieved from https://www.bauschhealth.com/investors/news-releases/news-release-details/bausch-health-announces-first-quarter-2023-results
[10] Bausch Health Companies Inc. (2023, February 22). Bausch Health Announces Fourth Quarter and Full Year 2022 Results. Retrieved from https://www.bauschhealth.com/investors/news-releases/news-release-details/bausch-health-announces-fourth-quarter-and-full-year-2022-results
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