Share This Page
Suppliers and packagers for generic pharmaceutical drug: ivabradine
✉ Email this page to a colleague
ivabradine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amgen Inc | CORLANOR | ivabradine | SOLUTION;ORAL | 209964 | NDA | Amgen Inc | 55513-813-28 | 28 AMPULE in 1 CARTON (55513-813-28) / 5 mL in 1 AMPULE (55513-813-01) | 2019-04-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ivabradine
Ivabradine is a selective sinus node inhibitor used primarily in the management of chronic heart failure and angina pectoris. Multiple pharmaceutical companies supply ivabradine globally, either as the branded product or as generic alternatives. The leading suppliers include international pharmaceutical corporations, regional generic manufacturers, and contract manufacturing organizations (CMOs).
Major Suppliers of Ivabradine
Branded Product Suppliers
1. Servier Group
- Product: Procoralan (brand name for ivabradine)
- Region: Europe, Asia, Latin America, select markets in Africa
- Market Status: Patented and exclusive rights held by Servier, with patent protections extending until approximately 2025-2027, depending on jurisdiction.
2. Amgen
- Product: Ivabradine formulations in certain markets as part of licensing agreements
- Region: North America and select markets
- Note: Licenses granted through partnerships with regional distributors or Servier.
Generic Manufacturers
1. Teva Pharmaceutical Industries
- Market: Europe, Middle East, North Africa, Latin America, Asia-Pacific (various regions post patent expiry)
- Notes: One of the largest generic drug producers, offering ivabradine after patent expiry or through licensing agreements.
2. Mylan (now part of Viatris)
- Market: Europe, Asia, Latin America
- Notes: Supplies generic ivabradine formulations in multiple markets.
3. Sandoz (Novartis)
- Market: Europe and other regions where patent has expired
- Notes: Licensed by patent holder or producing generic equivalents.
4. Zydus Cadila
- Market: India and regions with local approvals
- Notes: A significant regional generic manufacturer.
Contract Manufacturing Organizations (CMOs)
1. WuXi AppTec
- Services: Contract manufacturing for both branded and generic ivabradine
- Regions: Asia, Europe, North America
2. Partnering with global CMOs for formulation and API manufacturing is common among generic companies seeking scalability or capacity expansion.
Market Dynamics and Supply Chain Considerations
- Patent Status: The patent for ivabradine held by Servier is scheduled to expire around 2025-2027 across major markets, opening opportunities for generic manufacturers.
- Regulatory Approvals: Supplies depend on regional health authority approvals, including FDA (U.S.), EMA (Europe), and local agencies in emerging markets.
- API Sourcing: API (Active Pharmaceutical Ingredient) production is concentrated in China and India, with many manufacturers outsourcing API synthesis to these regions.
- Manufacturing Capacity: Several suppliers have expanded manufacturing capacity in response to increased clinical and retail demand.
Regional Availability and Market Penetration
| Region | Leading Suppliers | Key Notes |
|---|---|---|
| North America | Amgen, Teva, Viatris | Limited due to patent protections; generic entry expected post-2025 |
| Europe | Servier, Sandoz, Teva, Zydus Cadila | Strong presence; generics numerous after patent expiry |
| Asia-Pacific | Zydus, Wockhardt, IQVIA (API providers) | Larger share of generics production; regional market dominance |
| Latin America | Teva, Mylan | Growing generics market, local approval processes vary |
Key Considerations for Stakeholders
- Intellectual Property: Patent expiration significantly influences supplier landscape and price competition.
- Regulatory Compliance: Suppliers must meet regional quality and safety standards, influencing API sourcing and manufacturing practices.
- Supply Chain Risks: Concentration of API production in China and India adds geopolitical and logistical risks.
- Market Entry Opportunities: Post-patent expiry, significant potential for new entrants in multiple regions.
Key Takeaways
- Servier is the primary supplier of branded ivabradine; patents hold until 2025-2027.
- Multiple generic players, including Teva, Mylan, and Sandoz, supply ivabradine post-patent expiry.
- API manufacturing is concentrated in China and India, with current suppliers expanding capacity.
- Regional regulation and patent status heavily influence supply chain dynamics and market access.
- Opportunities exist for new entrants in markets where patent protections lapse and generic competition increases.
FAQs
1. Who is the original manufacturer of ivabradine?
Servier holds the original patent and markets ivabradine under the brand name Procoralan.
2. When will generic ivabradine become widely available?
Patent protections are expected to expire between 2025 and 2027 in key markets, enabling broader generic availability.
3. Which companies are leading suppliers of generic ivabradine?
Teva, Mylan (Viatris), Sandoz, Zydus Cadila, and Wockhardt.
4. How is the API for ivabradine produced globally?
Primarily in China and India, with manufacturing by multiple API suppliers and contract manufacturers.
5. What factors influence the supply chain stability of ivabradine?
Patent expiries, API sourcing concentration, regional regulatory approvals, and capacity expansion.
References
- Servier Group. (2022). Procoralan (ivabradine) approval and market information. Retrieved from [Company Website].
- U.S. Food and Drug Administration. (2022). Generic Drug Approvals and Market Status. https://www.fda.gov/drugs/buying-using-medicine-safely/generic-drugs
- European Medicines Agency. (2023). Market Authorizations for Ivabradine. https://www.ema.europa.eu/en/medicines/human/EPAR/procoralan
- Industry Reports. (2022). Global API and Generic Drugs Market Analysis. IQVIA.
- Patent Data. (2022). Global patent expirations and generic entry timelines. USPTO, EPO.
[1] U.S. Patent and Trademark Office. (2022). Patent expiration timelines.
More… ↓
