Last updated: July 27, 2025
Introduction
Stendra (generic name: avanafil) is a phosphodiesterase type 5 (PDE5) inhibitor primarily prescribed for erectile dysfunction (ED). Since its FDA approval in 2012, Stendra has gained prominence due to its rapid onset of action and favorable side effect profile. As the pharmaceutical market evolves, understanding the landscape of suppliers for Stendra is crucial for stakeholders, including healthcare providers, distributors, and competitors who wish to analyze supply chains, market access, and licensing dynamics.
Overview of Stendra Manufacturing and Supply Chain
1. Origin and Patent Status
Stendra was developed by Vivus, Inc., a biopharmaceutical company based in California. The drug’s patent protection extended until at least 2028, depending on the jurisdiction, which influenced licensing and manufacturing rights (1).
2. Manufacturing Facilities
Vivus originally held the intellectual property rights and related manufacturing agreements. The production of avanafil involves complex synthesis processes that require stringent quality controls aligned with GMP (Good Manufacturing Practice) standards. While Vivus oversees the development and marketing, the actual manufacturing may be outsourced to contract manufacturing organizations (CMOs), which is a common industry practice to ensure scalability and compliance.
Primary Suppliers and Licensing Agreements
1. Vivus Inc.
Vivus remains the primary patent and marketing holder for Stendra in the United States. The company is responsible for global regulatory filings, distribution, and licensing negotiations (2). Its direct involvement implies that Vivus largely controls supply channels within the territories where it holds exclusive rights.
2. Contract Manufacturing Organizations (CMOs)
The actual production of avanafil equations to high complexity, often outsourced to CMOs that specialize in pharmaceutical active pharmaceutical ingredients (APIs) and finished dosage forms (3). These CMOs may include:
- Lonza: Known for API manufacturing, potentially involved in the synthesis of avanafil.
- Alkermes and Lonza Group: Major players providing GMP-grade APIs and finished formulations.
Given strategic and capacity considerations, Vivus likely collaborates with multiple CMOs to meet global demand.
3. Licensing Partners and Distributors
For international markets, Vivus has engaged licensing agreements and distribution partnerships:
- FERRER INTERNATIONAL SSP (Europe): Distributes avanafil and manages sales operations in the European Union.
- Other regional partners: Licensing agreements with regional pharmaceutical companies to expand access across Latin America, Asia, and emerging markets (4).
By leveraging partnerships, Vivus extends its reach beyond direct manufacturing, relying on local suppliers.
Generic and Biosimilar Suppliers
Following patent expiration or licensing arrangements, generic manufacturers begin production:
1. Generic Manufacturers
In markets where patent rights have expired or are challenged, multiple generics have entered the market, including:
- Hetero Labs (India)
- Mylan (now part of Viatris): Has received FDA approval for generic avanafil.
- Sun Pharmaceutical Industries
These companies produce API and finished formulations, competing primarily on price and supply stability.
2. Regulatory Approvals for Generics
The entry of generics depends on patent litigation, regulatory approval, and market dynamics. The FDA approved several generic versions of avanafil in the U.S. from 2018 onward, expanding supplier options and potentially broadening the supply base (5).
Market Dynamics and Supply Stability
1. Supply Chain Risks
- Regulatory Hurdles: Delays in approvals can bottleneck supply.
- Manufacturing Capacity: CMOs must maintain high GMP standards; manufacturing disruptions could impact availability.
- Patent Litigation and Patent Term: Periods of patent disputes influence licensing and generic market entry.
2. Distribution Channels
- Pharmaceutical wholesalers and distributors, such as McKesson, Cardinal Health, and AmerisourceBergen, serve as intermediaries ensuring supply to pharmacies and healthcare providers.
- Online pharmacies and international markets rely on regional suppliers and licensed distributors.
Future Supply Considerations
- Expected patent expiry around 2028 may increase the number of generic suppliers.
- Strategic partnerships with CMOs will be crucial for scaling production capacity.
- Potential biosimilar or alternative PDE5 inhibitor competitors could influence supply strategies and market share.
Key Takeaways
- Controlled by Vivus: In the U.S. and some regions, Vivus remains the primary supplier and patent holder for Stendra.
- Manufacturing Outsourcing: The production relies heavily on CMOs specializing in APIs, with companies like Lonza possibly involved.
- Global Expansion: Licensing partners like Ferrer distribute Stendra across Europe, adding regional suppliers to the supply chain.
- Generic Competition: Post-patent expiration, manufacturers like Mylan and Sun Pharmaceuticals will become key players, increasing supply options and price competition.
- Supply Chain Risks: Regulatory delays, capacity limitations, and patent disputes can disrupt availability, highlighting the importance of diversified manufacturing sources.
FAQs
1. Who are the leading manufacturers of Stendra's active pharmaceutical ingredient (API)?
While Vivus owns the rights to Stendra, API synthesis is typically outsourced to specialist CMOs such as Lonza. Exact partnerships are often undisclosed but involve GMP-certified facilities capable of large-scale API production.
2. Are there approved generic versions of Stendra?
Yes. Following patent expiration, companies like Mylan and Sun Pharmaceuticals received FDA approval to produce generic avanafil, increasing supply options and market competition.
3. How does licensing affect the supply chain for Stendra?
Licensing agreements enable regional distributors, such as Ferrer in Europe, to manufacture, market, and distribute Stendra locally, thereby diversifying supply sources and expanding market access.
4. What risks could impact future supply of Stendra?
Patent disputes, manufacturing bottlenecks, supply chain disruptions, and regulatory delays can impair supply. The upcoming patent expiry around 2028 is expected to expand the supplier base significantly.
5. How do regional suppliers coordinate to meet global demand?
Through licensing agreements, regional manufacturers produce and distribute Stendra under brand or generic names. Coordination involves regulatory compliance, supply agreements, and quality assurance standards moderated by Vivus or licensing partners.
References
- Vivus. (2012). FDA Approval of Stendra. [Link]
- Vivus Inc. Annual Reports and Investor Presentations. (2022).
- U.S. Food and Drug Administration (FDA). Orange Book Entries for Avanafil. (2022).
- Ferrer International SSP. Licensing Agreements. (2022).
- FDA. ANDA Approvals for Generic Avanafil. (2018–2022).
