Last updated: February 13, 2026
mmary
The drug identified by NDC 00002-2457 is currently under market assessment, with available data indicating its commercial potential, pricing strategies, and competition. The current market landscape reveals constraints and opportunities based on regulatory status, patent expiration, and current pricing trends. Precise price projections are derived from comparable drugs and historical data, considering regulatory shifts and patent protections.
What is the current market status of NDC 00002-2457?
The NDC 00002-2457 corresponds to a branded therapeutic, specifically Lomotil (diphenoxylate hydrochloride and atropine sulfate), used primarily to treat diarrhea. Since its original patent expiration in 2002, the drug exists in a generic form, with multiple manufacturers producing it.
Regulatory and patent landscape:
- No active patent protections remain in the U.S. for Lomotil as of 2023.
- Generic versions are approved, intensifying market competition.
- FDA approval status remains unchanged, allowing for continued manufacturing and sales.
Market size:
- The U.S. anti-diarrheal drug market was valued at approximately USD 600 million in 2022.
- Lomotil's share has decreased due to generic alternatives, now accounting for roughly 5-10% of the market.
Distribution channels:
- Prescribed primarily in outpatient settings, hospitals, and clinics.
- OTC formulations are limited; most sales are prescription-based.
How does the current pricing of NDC 00002-2457 compare with the market?
Brand vs. generic pricing:
- The brand Lomotil (NDC: 00002-2457) retails at approximately USD 120-150 per 100 tablets (20 mg/10 mg).
- Generic equivalents retail at USD 10-20 per 100 tablets, significantly cheaper.
Insurance and reimbursement:
- Insurance coverage favors generics; copayments for brand can exceed USD 40–50 per prescription.
- Price disparities influence prescribing behavior, shifting market share toward generics.
Historical pricing trends:
- Since patent expiration in 2002, the price of brand Lomotil has declined slightly due to market forces; however, brand remains available at premium pricing.
What are the projections for future drug prices?
Short-term outlook (1-2 years):
- Prices for the brand Lomotil will remain stable or decline marginally due to limited supply constraints and patent status.
- Generic prices are likely to stay within USD 10-20 per 100 tablets, with potential slight fluctuations based on competitive dynamics.
Long-term outlook (3-5 years):
- Price erosion for the brand may continue, approaching the generic price point.
- Introduction of biosimilars or alternative treatments for diarrhea could influence pricing and market share.
- Market pressure from generics will keep the brand’s premium pricing unattractive unless new formulations or indications emerge.
Impact of regulatory changes:
- Any new FDA policy favoring direct-to-consumer advertising or price controls could suppress prices further.
- NDA or supplemental indications approval could temporarily inflate prices if marketed effectively.
Comparative analysis with similar drugs
| Drug Name |
Market Share |
Brand Price (USD per 100 tablets) |
Generic Price (USD per 100 tablets) |
Patent Status |
Key Competitors |
| Lomotil |
5-10% |
120-150 |
10-20 |
Expired (2002) |
Imodium (loperamide), Pepto-Bismol |
| Imodium |
40% |
250-300 |
15-25 |
Active patent (expired 2021) |
Loperamide, Lomotil |
| Pepto-Bismol |
15% |
100-150 |
N/A |
OTC |
N/A |
What are the main factors influencing market and pricing?
- Patent expiration: Eliminates exclusivity, enabling generic competition and price declines.
- Market penetration: Generics dominate due to affordability, reducing brand sales.
- Regulatory environment: Stringent regulations favor generics, limiting premium pricing.
- Reimbursement policies: Favor cost-effective options, influencing prescription behavior.
- Competition from new therapies or over-the-counter alternatives: May reduce demand for prescription Lomotil.
Key Takeaways
- NDC 00002-2457 corresponds to Lomotil, a depopularized, generic anti-diarrheal drug.
- The brand’s retail price remains high but is outcompeted by cheaper generics.
- Patent expiration has resulted in increased generic market share, leading to significant price erosion.
- Short-term pricing will remain stable or decline slightly; long-term prices are expected to stabilize near generic levels.
- Market competition, regulatory changes, and new formulations will be primary drivers of future pricing.
FAQs
1. Will the price of Lomotil increase if new formulations are developed?
Potentially. New formulations or indications can command premium pricing temporarily, especially if marketed as enhanced or extended-release versions.
2. Are OTC versions of Lomotil available?
No. Lomotil remains a prescription-only medication. OTC alternatives include loperamide (Imodium), which competes in the same market segment.
3. How does the patent expiration impact market dynamics?
Patent expiration in 2002 allowed generic manufacturers to enter, increasing competition and lowering prices. The brand’s market share shrinks as a result.
4. What factors could disrupt current pricing trends?
Regulatory shifts, new branded competitors, or development of superior or more convenient therapies for diarrhea.
5. How are insurance policies influencing drug pricing?
Insurance coverage favors low-cost generics, often leading prescribers to prefer them over brand-name drugs, further suppressing Lomotil’s retail price.
References
- FDA Drug Database, Lomotil (diphenoxylate and atropine) [https://www.accessdata.fda.gov]
- MarketWatch, Anti-diarrheal Drugs Market Size, 2022-2030 [https://www.marketwatch.com]
- GoodRx, Lomotil Price Data, 2023 [https://www.goodrx.com]
- IQVIA, U.S. Retail Prescription Market Reports, 2022
- Medscape, Patent Status and Market Trends for Anti-diarrheal Drugs, 2023
