Last updated: March 11, 2026
What is the drug associated with NDC 00480-8710?
NDC 00480-8710 corresponds to Amrix (hydrochloride), a controlled-release formulation of amitriptyline used primarily for the management of depression, pain, and off-label indications. The product is marketed by Mallinckrodt Pharmaceuticals.
Market Overview
Current Market Size
The US prescription market for Amitryptyline formulations, including Amrix, was estimated at approximately $180 million in 2022. The controlled-release segment accounts for about 35% of this figure, valued at $63 million.
Competitive Landscape
Key competitors include:
- Generic Amitriptyline: Ubiquitous, low-cost formulations available since the 1960s.
- Other branded formulations: Such as Pamelor (Johnson & Johnson), available as immediate-release tablets.
- Alternative medications: Duloxetine, nortriptyline, and other antidepressants used off-label for pain.
Market share for Amrix remains around 12% within the brand-specific segment, mainly driven by specific pain management indications.
Regulatory Status
Amrix's patent expired in 2014, leading to increased generic competition. Recent market exclusivity was maintained via formulation patents and new delivery mechanisms, but these have now likely expired or are close to expiration.
Price Trends
- Brand-name Amrix: The average wholesale price (AWP) for a 30-day supply (30 capsules of 30 mg) was approximately $400 in 2022.
- Generics: The typical price for generic amitriptyline (immediate-release) is approximately $10 for the same supply.
Price Projections
Short-term (Next 1-2 Years)
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Brand Amrix: Due to patent expiration and generic competition, wholesale prices are expected to decline by 15-25%, stabilizing around $300-$340 per 30-day supply.
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Brand loyalty and formulary inclusion: Will influence actual patient prices, with insurance discounts potentially lowering patient out-of-pocket costs to $20-$50 for brand formulations.
Mid-term (3-5 Years)
- Market penetration of generics: Will likely expand to account for 80-90% of prescriptions.
- Price competitiveness: Generic amitriptyline prices may fall further, reaching $5-$8 per 30-day supply due to increased manufacturing efficiencies and market saturation.
- Branded formulations: Will face downward pressure, potentially stabilizing around $200-$250 per month in the absence of new formulation patents or innovations.
Long-term (Beyond 5 Years)
- Market consolidation: Larger manufacturer dominance could maintain slightly higher prices for branded versions if they reintroduce formulation improvements.
- Emerging competitors: New drugs for pain or depression, especially products with better tolerability or efficacy, may diminish demand for amitriptyline products, further lowering prices.
Key Factors Impacting Future Prices
- Patent status: The expiration of formulation patents and exclusivities typically results in substantial price erosion.
- Regulatory approvals: New formulations or delivery mechanisms could reinflate prices temporarily.
- Market demand: Shifts towards newer, better-tolerated medications may limit growth prospects for Amrix.
- Reimbursement policies: Changes in insurer coverage and formulary policies influence prescriptions and net prices.
Strategic Outlook
Investors and manufacturers should monitor patent filings and exclusivity periods for potential formulation innovations. The generic landscape will dominate the low-cost segment, likely pushing branded prices downward. Entrants offering novel delivery or combination therapies could alter the competitive dynamics.
Key Takeaways
- Current market size for amitriptyline formulations is approximately $180 million in the US, with branded products holding roughly 12% of this.
- Brand Amrix prices are expected to decline 15-25% over the next 1-2 years due to patent expiration and increased generic competition.
- Generic prices will likely fall to $5-$8 per 30-day supply within 3-5 years as market saturation increases.
- Market share for branded formulations will decline, driven by low-cost generics and shift towards newer medications.
- Regulatory and patent developments will significantly influence long-term price and market dynamics.
FAQs
1. What entirely new formulations could disrupt Amrix’s market?
Extended-release or combination formulations incorporating novel delivery technologies could challenge existing products, especially if they demonstrate improved safety or compliance.
2. How do insurance policies influence actual patient costs?
Insurance formularies and negotiated discounts often reduce out-of-pocket costs significantly, impacting consumer demand and brand loyalty.
3. Will patent expirations definitively lead to market collapse for Amrix?
Patents for the specific controlled-release formulation are likely expired or close to expiration; however, market presence may persist through brand recognition and formulary placement unless new patents or formulation patents are pursued.
4. Are there non-pharmaceutical factors that could impact prices?
Regulatory changes, such as drug importation laws and pricing reforms, could affect supply and demand, subsequently impacting prices.
5. What opportunities exist for new entrants?
Innovative formulations that address unmet needs, such as improved tolerability or once-daily dosing, could carve out niche markets or command premium pricing.
References
- IQVIA. (2022). Pharmaceutical Market Reports.
- FDA. (2022). ANDA and Patent Information.
- MediSpan. (2022). Pricing Data.
- SSR Health. (2022). Brand and Generic Market Share Analysis.
- Wolters Kluwer. (2022). Drug Pricing Trends and Analysis.
