Last updated: February 24, 2026
What is the Drug Associated with NDC 00187-5150?
NDC 00187-5150 corresponds to Amitryptyline Hydrochloride Tablets, a tricyclic antidepressant approved by the U.S. Food and Drug Administration (FDA). It is primarily prescribed for depression, neuropathic pain, and off-label uses such as migraine prevention.
Market Landscape and Competitive Position
Market Size and Usage
- Estimated U.S. prescription volume (2022): approximately 10-12 million prescriptions.
- Indications: depression, chronic neuropathic pain, migraine prophylaxis.
- Patient segments: adult, elderly, off-label pediatric uses.
Market Drivers
- Aging population with increased chronic pain conditions.
- Long-standing generic market with established prescribing patterns.
- Limited new entrants due to patent expiration and generic competition.
Key Competitors
| Drug Name |
Class |
Market Share (2022) |
Notes |
| Amitryptyline (generic) |
Tricyclic antidepressant |
>90% |
Dominates due to low cost and long approval history |
| Nortriptyline |
Tricyclic antidepressant |
5-8% |
Slightly preferred for fewer side effects |
| Desipramine |
Tricyclic antidepressant |
2-3% |
Niche use, off-label for pain |
Regulatory and Patent Status
- Patent for Amitryptyline expired in the early 1970s.
- The drug is available solely as a generic, with no recent patent exclusivities.
- FDA approval allows manufacturing and distribution without geographic restrictions initially.
Price Projections and Trends
Current Price Benchmarks (2023)
| Packaging Size |
Average Wholesale Price (AWP) |
Estimated Retail Price (for a 30-day supply) |
| 25 mg, 30 tablets |
$6.00 |
~$10.00 |
| 75 mg, 30 tablets |
$8.00 |
~$14.00 |
Prices vary by pharmacy and insurance coverage.
Historical Price Trends
- Prices have remained relatively stable over past five years.
- Slight decreases correlated to increased competition among generics.
- No significant price hikes observed, unlike branded counterparts.
Future Price Projections (Next 3-5 Years)
- Price stability is expected due to high generic market saturation.
- Potential for further reductions if biosimilars or alternative therapies become more prevalent.
- Impact of policy changes (e.g., drug price reforms, Medicare negotiations) could influence retail prices.
External Factors Affecting Price
- Wholesale distributor pricing strategies.
- Insurance formulary inclusion/exclusion.
- Manufacturer supply chain stability.
Market Challenges and Opportunities
Challenges
- Growing concerns about side effects and newer antidepressants with better safety profiles.
- The increasing availability of selective serotonin reuptake inhibitors (SSRIs) reduces demand.
- Regulatory pressure on drug pricing policies.
Opportunities
- Expansion into off-label uses such as sleep disorders and PTSD.
- Differentiation through formulation improvements or combination therapies.
- Potential market share gains in pain management niches.
Strategic Recommendations
- Maintain competitive pricing, emphasizing low-cost generics.
- Focus on patient adherence programs to improve outcomes.
- Monitor policy developments affecting drug reimbursement rates.
Key Takeaways
- NDC 00187-5150 corresponds to generic Amitryptyline Hydrochloride tablets.
- The market is mature, with high generic penetration and stable prices.
- The drug faces competition from other antidepressants and off-label therapies.
- Price projections indicate minimal fluctuations over the next five years, with slight downward trends possible.
- Market growth is limited but remains relevant for cost-sensitive treatment settings.
Frequently Asked Questions
1. Is there potential for patent protection or new formulations of Amitryptyline?
No, patent protections have expired for decades, and current formulations are standard.
2. How does insurance coverage impact the retail price?
Insurance typically covers generic Amitryptyline with minimal copayments, pushing patient out-of-pocket costs down.
3. Are there any upcoming regulatory changes that could affect pricing?
Potential policy shifts targeting drug pricing transparency could influence reimbursement and retail prices.
4. How does Amitryptyline compare with newer antidepressants?
It has a lower cost but may have a higher side effect profile, influencing prescriber choices.
5. What is the impact of global supply chain issues on this drug?
Supply disruptions are unlikely given its long-established manufacturing processes and widespread availability.
References
[1] IQVIA. (2022). Prescription Trends Report.
[2] FDA. (2023). Drug Approvals and Labeling.
[3] Medicare.gov. (2023). Formularies and pricing information.
