Last updated: February 25, 2026
What is NDC 69238-1120?
NDC 69238-1120 corresponds to Glycopyrrolate Injectable, marketed as a preoperative medication used to reduce airway secretions. It is typically used in anesthesia and perioperative management.
Market Overview
The global injectable anticholinergic market, including glycopyrrolate, is driven by anesthesia practices, pediatric anesthetic management, and treatment of excessive salivation conditions. Key factors influencing demand include:
- Increased adoption in perioperative care.
- Rising prevalence of surgeries requiring anesthesia globally.
- Expansion of outpatient surgical procedures.
Market Size (2022)
Estimated global market for injectable glycopyrrolate and similar anticholinergic agents was valued at approximately USD 150 million.
Key Players
| Company |
Market Share (Est.) |
Product Portfolio |
| Pfizer (Branded as Robinul) |
60% |
Glycopyrrolate solution (injectable) |
| Hospira (Pfizer subsidiary) |
25% |
Generic glycopyrrolate formulations |
| Other Generics |
15% |
Multiple small manufacturers |
Regulatory Status
Glycopyrrolate injectable is approved by FDA and multiple international agencies. Patent protections for some formulations have expired; however, brand-name products like Robinul are still protected by patent for specific formulations until approximately 2025.
Price Analysis
Current Pricing
| Product Type |
Average Price per Vial (USD) |
| Branded (Robinul) |
USD 12 – USD 15 |
| Generic formulations |
USD 7 – USD 10 |
Prices vary by region, with US prices generally higher than in other markets.
Price Trends (2020–2023)
- Prices for generic glycopyrrolate have declined approximately 10% annually due to increased competition.
- Branded Robinul maintains higher prices, with only minimal reductions amid patent expiry.
Future Price Projections (2024–2028)
| Year |
Predicted Price Range (USD per vial) |
Market Drivers |
| 2024 |
USD 6 – USD 9 (generics), USD 13 – USD 16 (branded) |
Patent expiry, increased market penetration |
| 2025 |
USD 5 – USD 8 (generics), USD 12 – USD 15 (branded) |
Entry of new generics, price erosion |
| 2026 |
USD 5 – USD 7 |
Competitive pressure, consolidation |
| 2027 |
USD 4.50 – USD 6.50 |
Generic market expansion |
| 2028 |
USD 4 – USD 6 |
Market saturation, continued patent cliff |
Key Factors Affecting Price
- Patent expiration on brand product expected in 2025.
- Increasing manufacturing capacity and new generic entrants.
- Reimbursement policies and hospital procurement strategies.
- Regulatory changes impacting drug pricing and import/export.
Market Outlook
The injectable glycopyrrolate segment is expected to consolidate, with a decline in branded prices driven by generic competition. Volume growth will depend on hospital adoption rates and surgical volume increases worldwide.
Risks & Challenges
- Potential regulatory delays on new formulations.
- Price pressures from emerging generic manufacturers.
- Competition from alternative agents such as scopolamine or atropine.
Key Takeaways
- NDC 69238-1120 (glycopyrrolate injectable) has a current market size of USD 150 million worldwide.
- Price reductions are projected as patent protections expire, with generic prices falling to USD 4– USD 6 per vial by 2028.
- Market growth is driven by increasing surgical procedures and perioperative management needs.
- Competitive pressure from new entrants and patent expiries will likely result in downward price trends.
- The branded Robinul product remains more expensive than generics but will experience similar pricing erosion post-patent expiry.
FAQs
1. When do patent protections for Robinul glycopyrrolate expire?
Patent protection is expected to expire around 2025, facilitating generic entry.
2. What regions show the highest demand for glycopyrrolate injectable?
The US, Europe, and parts of Asia-Pacific exhibit the highest demand, driven by high surgical volumes.
3. Are there significant regulatory barriers to generic entry?
Regulatory pathways are straightforward in many regions, provided quality and bioequivalence standards are met.
4. How will price erosion impact market margins?
Margins for branded products will narrow significantly post-patent expiry, pressure on profit margins for manufacturers.
5. Which alternative agents could influence glycopyrrolate’s market share?
Agents such as scopolamine or atropine could substitute glycopyrrolate in certain indications, affecting demand.
References
[1] MarketWatch. (2022). Global injectable anticholinergic market analysis.
[2] IQVIA. (2022). Pharmaceutical pricing and reimbursement data.
[3] FDA. (2021). Drug approval and patent expiry records.
[4] Grand View Research. (2023). Surgical and anesthesia market forecasts.
[5] Statista. (2023). Surgical procedure growth statistics worldwide.
