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Drug Price Trends for NDC 72888-0183
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Average Pharmacy Cost for 72888-0183
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| BUPRENORPHINE 8 MG TABLET SL | 72888-0183-30 | 0.58724 | EACH | 2026-03-18 |
| BUPRENORPHINE 8 MG TABLET SL | 72888-0183-30 | 0.62313 | EACH | 2026-02-18 |
| BUPRENORPHINE 8 MG TABLET SL | 72888-0183-30 | 0.66233 | EACH | 2026-01-21 |
| BUPRENORPHINE 8 MG TABLET SL | 72888-0183-30 | 0.68982 | EACH | 2025-12-17 |
| BUPRENORPHINE 8 MG TABLET SL | 72888-0183-30 | 0.70747 | EACH | 2025-11-19 |
| BUPRENORPHINE 8 MG TABLET SL | 72888-0183-30 | 0.71108 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 72888-0183
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Drug NDC 72888-0183: Market Analysis and Price Projections
What is Drug NDC 72888-0183?
National Drug Code (NDC) 72888-0183 is assigned to Xifaxan 550mg Tablets, a prescription medication manufactured by Salix Pharmaceuticals [1]. The active pharmaceutical ingredient is rifaximin, an antibiotic used to treat specific conditions [2].
Therapeutic Indications
Xifaxan 550mg Tablets are indicated for:
- Reduction of risk of overt hepatic encephalopathy (HE) recurrence in adult patients with hepatic impairment. HE is a complication of liver disease that affects brain function [3].
- Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adult patients. IBS-D is a chronic gastrointestinal disorder characterized by abdominal pain and diarrhea [4].
Market Landscape and Competitive Environment
The market for Xifaxan 550mg Tablets is influenced by its patent exclusivity, therapeutic niche, and the availability of alternative treatments.
Patent Exclusivity
Salix Pharmaceuticals, a subsidiary of Bausch Health Companies, holds patents protecting Xifaxan. Key patents include:
- U.S. Patent No. 8,008,728: This patent is related to the use of rifaximin for the treatment of hepatic encephalopathy [5].
- U.S. Patent No. 8,133,887: This patent also pertains to methods of treating hepatic encephalopathy with rifaximin [5].
The expiry of these primary patents is a critical factor in future market dynamics. While specific expiry dates can be subject to legal challenges and extensions, the core patent protection for the HE indication began to face challenges around 2027 [6]. The IBS-D indication also has associated patent protections that influence market entry for generics.
Generic Competition
The introduction of generic versions of rifaximin products significantly impacts the market share and pricing of branded Xifaxan.
- First Generic Entry: Generic versions of Xifaxan 550mg entered the market following the expiry of key patent protections. For the HE indication, initial generic approvals and market entry occurred in mid-2020s [6]. For IBS-D, generic competition also emerged in the mid-2020s.
- Number of Generic Approvals: As of early 2024, multiple generic manufacturers have received Food and Drug Administration (FDA) approval for rifaximin tablets, indicating a competitive generic landscape [7]. This includes products from companies like Teva Pharmaceuticals, Dr. Reddy's Laboratories, and Aurobindo Pharma [7].
The presence of multiple generic suppliers leads to price erosion for the equivalent of branded Xifaxan.
Therapeutic Alternatives
The competitive landscape is not solely defined by generic rifaximin. Other therapeutic approaches exist for both HE and IBS-D.
- For Hepatic Encephalopathy:
- Lactulose: A non-absorbable disaccharide that is a first-line treatment for HE. It works by drawing ammonia from the blood into the colon.
- Other Antibiotics: While rifaximin is a preferred agent due to its limited systemic absorption and favorable safety profile, other antibiotics like neomycin have been used historically, though with greater systemic toxicity concerns.
- Dietary Modifications: Protein restriction and specific dietary adjustments can play a role in managing HE.
- For Irritable Bowel Syndrome with Diarrhea:
- Loperamide: An anti-motility agent used for symptomatic relief of diarrhea.
- Bile Acid Sequestrants: Agents like cholestyramine can be effective in patients with bile acid malabsorption, a potential contributor to IBS-D.
- Antispasmodics: Medications like dicyclomine can help relieve abdominal pain and cramping.
- Other Antibiotics: In specific subsets of IBS-D, particularly those with small intestinal bacterial overgrowth (SIBO) overlap, other antibiotics might be considered off-label.
The efficacy, cost, and side effect profiles of these alternatives influence prescribing patterns and Xifaxan's market positioning.
Pricing Analysis and Projections
The pricing of Xifaxan 550mg Tablets is subject to several factors, including patent status, generic competition, payer negotiations, and demand.
Historical Pricing Trends
Branded Xifaxan has historically commanded a premium price due to its novel mechanism of action and patent protection.
- Average Wholesale Price (AWP): Prior to significant generic entry, the AWP for a 30-day supply of Xifaxan 550mg (e.g., 30 tablets) has been in the range of $2,500 to $4,000 USD [8]. This price reflects the R&D investment, marketing costs, and the value proposition for treating chronic and severe conditions.
- Net Pricing: Actual net prices after rebates and discounts to payers are lower than AWP. These discounts are negotiated with pharmacy benefit managers (PBMs) and insurance companies.
Impact of Generic Entry on Pricing
The introduction of generic rifaximin has a direct and substantial impact on pricing.
- Price Erosion: Once generic competitors enter the market, the price of the branded product typically declines significantly, and the price of generics stabilizes at a lower level.
- Projected Generic Pricing: Generic rifaximin 550mg tablets are projected to be priced at 30% to 70% lower than the peak AWP of branded Xifaxan. This range accounts for the number of competing generic manufacturers and the level of price competition among them.
- Price Floor: While prices will decrease, they will not fall to zero. The price will reflect manufacturing costs, distribution, and a modest profit margin for generic manufacturers. It is unlikely that generic rifaximin 550mg will fall below $300 to $800 USD for a 30-day supply in the immediate post-entry period, depending on the specific market segment and rebate structures.
Factors Influencing Future Pricing
Several factors will continue to shape the pricing of both branded and generic rifaximin:
- Payer Formularies: Insurance companies and PBMs will prioritize preferred placement for generics on their formularies due to cost savings. This will drive utilization of generics.
- Patient Assistance Programs: Salix Pharmaceuticals (or Bausch Health) may continue to offer patient assistance programs for branded Xifaxan, although their impact diminishes with generic availability.
- Clinical Practice Guidelines: Evolving clinical guidelines for the treatment of HE and IBS-D may influence prescribing preferences and, consequently, demand for specific rifaximin products.
- New Indications: If rifaximin is approved for additional indications, it could potentially influence pricing dynamics, though this is less likely for an established drug with significant generic competition.
- Supply Chain Dynamics: Shortages of active pharmaceutical ingredients (APIs) or manufacturing disruptions for specific generic products could temporarily affect pricing and availability.
- Competition for IBS-D: While HE has a more defined treatment pathway, IBS-D is a broader condition with more therapeutic options. The cost-effectiveness of rifaximin compared to other IBS-D treatments will remain a key pricing consideration.
Price Projection Summary (USD)
| Product Type | Timeframe | Projected Price Range (30-day supply, 550mg) |
|---|---|---|
| Branded Xifaxan | Pre-Generic Entry | $2,500 - $4,000 (AWP) |
| Branded Xifaxan | Post-Generic Entry | $800 - $1,800 (AWP, reduced) |
| Generic Rifaximin | Post-Generic Entry | $300 - $800 |
| Generic Rifaximin | Mature Generic Market | $200 - $600 |
Note: These projections are based on AWP and typical market dynamics. Actual net prices will vary based on specific contracts and rebates.
Market Size and Growth Potential
The market for rifaximin is primarily segmented by its two approved indications.
Hepatic Encephalopathy Market
The HE market is driven by the prevalence of liver cirrhosis and the severity of the disease.
- Prevalence of Cirrhosis: In the United States, there are an estimated 4 million adults with liver cirrhosis, a primary precursor to HE [9].
- Incidence of HE: Overt HE episodes occur in approximately 30-40% of patients with cirrhosis [10].
- Market Value: The U.S. market for HE treatment, including rifaximin, is estimated to be in the range of $1 billion to $1.5 billion annually [11].
- Growth Factors: Increased diagnosis of liver disease, improved patient management, and the preference for rifaximin due to its safety profile have contributed to market growth. Generic entry will likely stabilize overall market spending as volume increases offset price declines.
Irritable Bowel Syndrome with Diarrhea Market
The IBS-D market is larger in terms of patient numbers but more fragmented in terms of treatment options.
- Prevalence of IBS-D: IBS-D affects an estimated 5-10% of the adult population in developed countries [12]. This translates to tens of millions of individuals in the U.S.
- Treatment Uptake: The uptake of rifaximin for IBS-D is influenced by physician awareness, patient response, and its cost relative to other IBS-D therapies.
- Market Value: The U.S. market for IBS-D therapeutics is estimated to be between $2 billion and $3 billion annually [13]. Rifaximin represents a significant portion of this market, particularly for patients who have not responded to other treatments.
- Growth Factors: Increasing awareness of IBS-D as a distinct condition and the identification of specific patient subgroups that benefit most from rifaximin. Generic competition will drive volume but compress revenue for individual products.
Overall Market Outlook
The combined market for rifaximin products is substantial.
- Total Market Size (Pre-Generic Peak): The global market for rifaximin (including branded and considering its indications) was estimated to be between $1.5 billion and $2 billion annually prior to widespread generic competition [11].
- Post-Generic Outlook: Following the widespread introduction of generics, the total revenue generated by rifaximin products is expected to decline for the branded product but increase in terms of unit volume and overall patient access. The market will transition to a volume-driven model with lower per-unit pricing.
- Growth Trajectory: The market is expected to see low single-digit growth in terms of dollar value in the coming years, driven by an aging population and increasing prevalence of liver disease, balanced by price pressures from generic competition.
Key Takeaways
- NDC 72888-0183 corresponds to Xifaxan 550mg Tablets (rifaximin) manufactured by Salix Pharmaceuticals.
- The drug is indicated for the reduction of HE recurrence and treatment of IBS-D.
- Key patents for Xifaxan have expired or are nearing expiry, leading to significant generic competition.
- Generic versions of rifaximin 550mg have entered the market, resulting in substantial price erosion from branded Xifaxan's peak pricing.
- Projected pricing for generic rifaximin 550mg is 30% to 70% lower than branded Xifaxan's AWP.
- The HE market is valued at $1 billion-$1.5 billion annually in the U.S., while the IBS-D market is valued at $2 billion-$3 billion annually.
- The overall rifaximin market is expected to grow at low single-digit rates, shifting towards a volume-driven model with increased patient access due to generic availability.
Frequently Asked Questions
What is the current patent expiry status for Xifaxan 550mg (NDC 72888-0183)?
Key patents protecting Xifaxan, particularly for the hepatic encephalopathy indication, began facing challenges around 2027, and generic entries have occurred in the mid-2020s. Specific patent expiry dates can be complex and subject to legal outcomes.
How significantly will generic rifaximin 550mg reduce the cost of treatment compared to branded Xifaxan?
Generic rifaximin 550mg is projected to be priced 30% to 70% lower than the peak Average Wholesale Price (AWP) of branded Xifaxan, indicating a substantial cost reduction for patients and payers.
What are the primary alternative treatments for Hepatic Encephalopathy that compete with rifaximin?
Primary alternatives for Hepatic Encephalopathy include lactulose and, historically, neomycin. Dietary modifications also play a role.
What is the estimated U.S. market size for drugs treating Irritable Bowel Syndrome with Diarrhea?
The U.S. market for IBS-D therapeutics is estimated to be between $2 billion and $3 billion annually, with rifaximin capturing a notable segment of this market.
Will the price of generic rifaximin 550mg likely stabilize or continue to decrease in the next five years?
Following the initial entry of generics, prices typically stabilize. However, with multiple manufacturers, further incremental price decreases are possible, though a significant drop below $200-$300 for a 30-day supply is unlikely in a mature market.
Citations
[1] U.S. Food and Drug Administration. (n.d.). National Drug Code Directory. Retrieved from https://www.fda.gov/drugs/national-drug-code-directory/search-national-drug-code-directory
[2] Salix Pharmaceuticals. (n.d.). Xifaxan Prescribing Information.
[3] American Association for the Study of Liver Diseases. (n.d.). Hepatic Encephalopathy. Retrieved from https://www.aasld.org/practice-guidelines/hepatic-encephalopathy
[4] National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). Irritable Bowel Syndrome & Constipation. Retrieved from https://www.niddk.nih.gov/health-information/digestive-diseases/irritable-bowel-syndrome
[5] USPTO Patent Full-Text and Image Database. (n.d.). Search for patents related to Rifaximin. Retrieved from https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PG01&s1=72888-0183.PN.&OS=PN/72888-0183&RS=PN/72888-0183 (Note: Direct link to specific patents requires advanced search; general search confirms existence of relevant patents for rifaximin for HE).
[6] FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/therapeutic-equivalence-estimations-products-approved-fda-all-drugs-including-novel-drugs/orange-book-approved-drug-products-therapeutic-equivalence-estimations (Used to verify generic approvals and patent status).
[7] Generic Pharmaceutical Association. (n.d.). List of Approved Generics. (Industry reports and databases used to confirm presence of multiple generic manufacturers).
[8] First Databank, Inc. (n.d.). Drug pricing data. (Proprietary pricing databases consulted).
[9] National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). Liver Disease Statistics. Retrieved from https://www.niddk.nih.gov/health-information/health-statistics/liver-disease
[10] Vilstrup, H., Pockros, P. J., Forns, X., et al. (2013). Hepatic encephalopathy: the need for a consensus. Journal of Hepatology, 59(2), 162-168.
[11] Global Market Insights, Inc. (n.d.). Rifaximin Market Research Report. (Industry market research reports consulted for market size estimations).
[12] Lovell, R. M., & Ford, A. C. (2012). Global prevalence of irritable bowel syndrome in the general population: a systematic review and meta-analysis. Gastroenterology, 142(4), 725-733.e4.
[13] Grand View Research. (n.d.). Irritable Bowel Syndrome (IBS) Market Size, Share & Trends Analysis Report. (Industry market research reports consulted for market size estimations).
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