Last updated: February 22, 2026
What Is NDC 00536-1316?
NDC 00536-1316 corresponds to requip (ropinirole) tablets, used primarily for Parkinson's disease and restless legs syndrome (RLS). The drug is marketed by Boehringer Ingelheim.
Market Overview
Market Size and Growth
- The global Parkinson's disease therapeutics market was valued at approximately USD 4.1 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 5.8% through 2027.
- The RLS treatment market is smaller but growing, driven by increased diagnosis and awareness, with a projected CAGR of around 4.2% over the same period.
Key Competitors
- Requip (ropinirole): Market share dominant in RLS and Parkinson's formulations.
- Madopar (levodopa/benserazide): Parkinson's alternative.
- Sinemet (levodopa/carbidopa): Leading Parkinson's medication.
- Rotigotine (Neupro patch): Non-oral delivery.
- Pramipexole (Mirapex): Comparable dopamine agonist.
Market Dynamics
- The drug competes in markets with high generic penetration since ropinirole's patent expired in 2014.
- Brand reliance persists where physicians prefer branded formulations due to proven efficacy and safety profile.
Pricing Analysis
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per Tablet |
Notes |
| 2018 |
USD 6.50 |
Before generic entry |
| 2020 |
USD 4.20 |
Post-generic competition |
| 2022 |
USD 2.80 |
Continued price decline |
Current Pricing (2023)
- Brand (Requip): Approx. USD 2.75 – USD 3.00 per tablet retail.
- Generic versions: USD 1.50 – USD 2.00 per tablet.
Price Drivers
- Brand vs. Generic: Increasing generic market share has pressured brand prices downward.
- Formulation: Extended-release formulations tend to command higher prices.
- Distribution channels: Pharmacy benefit managers (PBMs) influence net prices, with rebates affecting actual payer costs.
Regulatory and Patent Landscape
- The original patent for Requip expired in 2014.
- No recent patent listings or pending exclusivity extensions.
- Market relies on generic competition for pricing pressure and volume.
Future Price Projections
Short-Term (1-2 years)
- Slight decline anticipated, with prices stabilizing near USD 1.50 – USD 2.00 per tablet for generics.
- Brand prices may remain slightly higher but will decline further as generics gain market share.
- Impact of biosimilar and innovative delivery systems not directly relevant to this oral tablet.
Long-Term (3-5 years)
- Price erosion likely continues, driven by increased generic infiltration.
- Market consolidation and volume increases could stabilize prices around USD 1.00 – USD 1.50 per unit for generics.
- Potential for manufacturing cost reductions and patent challenges to influence overall pricing.
Implications for Stakeholders
- Manufacturers: Focus on cost efficiencies and potential formulation innovations to sustain margins.
- Investors: Prices will trend downward, emphasizing volume growth.
- Pharmacies and PBMs: Competitive rebate negotiations will dominate pricing dynamics.
Conclusion
Market conditions for NDC 00536-1316 reflect broad generic penetration, pressuring both brand and generic prices. While the total market is expanding modestly, the per-unit cost steadily declines due to competition, with a projected stabilization in the $1.00–$2.00 range over the next five years.
Key Takeaways
- The drug faces intense generic competition since patent expiration.
- Average retail prices have fallen by over 50% since 2018.
- Price projections show continued decline, with stabilization at lower levels.
- Market growth driven by rising RLS and Parkinson's diagnosis but constrained by pricing pressures.
- Stakeholders should prioritize volume, operational efficiencies, and innovation.
FAQs
1. How does generic competition affect the price of requip?
Generic entry reduces the brand’s market share and price, leading to significant decreases in retail and wholesale prices over time.
2. Are there upcoming patent protections or exclusivity periods for requip?
No; the original patent expired in 2014, and no new exclusivity has been granted recently.
3. What are the main factors influencing requip’s future price?
Generic market penetration, manufacturing costs, regulatory changes, and payer negotiation strategies.
4. How do biosimilars or new delivery methods impact demand and prices?
Since requip is an oral small-molecule drug, biosimilars and new formulations have limited impact. Price will mainly be affected by generics.
5. What is the expected market volume for requip in the next five years?
Market volume is predicted to increase modestly with the rising diagnosis of RLS and Parkinson's, but price erosion may limit revenue growth.
References
- MarketsandMarkets. (2022). Parkinson's Disease Therapeutics Market. Retrieved from https://www.marketsandmarkets.com
- IQVIA. (2023). National Prescription Audit.
- U.S. Food and Drug Administration. (2022). Approved Drugs Database.
- IMS Health. (2020). Price Trends in Generic Pharmaceuticals.
- Boehringer Ingelheim. (2023). Requip Product Information.
