Suppliers and packagers for generic pharmaceutical drug: OLAPARIB

OLAPARIB

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558	NDA	AstraZeneca Pharmaceuticals LP	0310-0569-12	120 TABLET, FILM COATED in 1 BOTTLE (0310-0569-12)	2017-08-17
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558	NDA	AstraZeneca Pharmaceuticals LP	0310-0569-60	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0569-60)	2017-08-17
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558	NDA	AstraZeneca Pharmaceuticals LP	0310-0578-12	120 TABLET, FILM COATED in 1 BOTTLE (0310-0578-12)	2017-08-17
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558	NDA	AstraZeneca Pharmaceuticals LP	0310-0578-60	60 TABLET, FILM COATED in 1 BOTTLE (0310-0578-60)	2017-08-17

Olaparib: Key Suppliers and Intellectual Property Landscape

Last updated: February 19, 2026

This analysis identifies critical suppliers for the pharmaceutical drug olaparib, focusing on active pharmaceutical ingredient (API) manufacturers and key intermediates. It also examines the intellectual property landscape, including patent expirations and potential generic entry points, relevant for R&D and investment decisions in the oncology sector.

What is Olaparib and Its Market Significance?

Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor used primarily in the treatment of certain types of ovarian, breast, prostate, and pancreatic cancers. These cancers are characterized by BRCA gene mutations. The drug's efficacy in targeted therapy has established its significant role in precision oncology, driving consistent demand and a substantial market value.

The global market for olaparib has seen growth attributed to increasing cancer incidence, advancements in genetic testing identifying eligible patient populations, and the drug's proven clinical benefits. Key therapeutic areas include maintenance therapy for recurrent ovarian cancer and treatment of metastatic castration-resistant prostate cancer with specific genetic alterations.

Who are the Primary API Manufacturers for Olaparib?

The manufacturing of olaparib API is a complex process involving specialized chemical synthesis. Several Contract Development and Manufacturing Organizations (CDMOs) and API manufacturers are involved in its production, serving the originator and potentially the generic market.

• AstraZeneca PLC (Originator): As the originator, AstraZeneca holds the primary manufacturing and supply chain control for Lynparza®, the brand name for olaparib. Their established manufacturing network is the initial source.
• Major CDMOs: The production of olaparib API and key intermediates is outsourced to several global CDMOs with expertise in complex organic synthesis. These include:
  • Lonza Group AG: Known for its broad capabilities in small molecule API manufacturing, Lonza is a significant player in the supply chain for various pharmaceuticals.
  • Catalent, Inc.: Catalent offers integrated manufacturing solutions from development to commercial supply, including specialized API production.
  • WuXi AppTec Co., Ltd.: A prominent global CDMO, WuXi AppTec provides comprehensive R&D and manufacturing services, including for oncology drugs.
  • Grand Pharma (China): Specializes in pharmaceutical manufacturing and has capabilities for complex API synthesis.
  • Divi’s Laboratories Limited (India): A large-scale API manufacturer with a strong presence in producing complex molecules.

The specific involvement of these CDMOs often depends on agreements with AstraZeneca or generic manufacturers post-patent expiry. Due diligence on supply chain resilience and quality assurance from these entities is crucial for any stakeholder.

What are the Key Intermediates in Olaparib Synthesis?

The synthesis of olaparib involves multiple chemical steps, requiring specific advanced intermediates. The supply of these intermediates is critical for API manufacturers.

• 4-(Piperazin-1-ylmethyl)benzoic acid: A key building block, often synthesized through multi-step processes.
• 5-Fluoro-2,4-dinitrobenzoic acid: Another crucial precursor molecule in the olaparib synthesis pathway.
• 3-Azabicyclo[3.2.1]octane derivatives: The synthesis of the bicyclic amine core requires specialized reagents and controlled conditions.
• Phthalazinone core components: Precursors for constructing the fundamental phthalazinone structure of olaparib.

Manufacturers specializing in custom synthesis and fine chemicals are likely involved in producing these intermediates. Supply chain mapping for these specific chemical entities is essential for assessing manufacturing risks and cost structures.

What is the Intellectual Property Landscape for Olaparib?

The intellectual property surrounding olaparib is primarily defined by patents covering the compound itself, its synthesis, and its therapeutic uses. Patent expiry dates are critical for anticipating generic competition.

Key Patents and Expiration Dates:

• Composition of Matter Patent:

  • US Patent 6,498,155 B1: This foundational patent covers the olaparib compound. It was granted on December 24, 2002. The term for this patent, including any extensions, is a significant factor. For a patent granted in 2002, its basic term would have expired in 2019. However, patent term extensions (PTEs) and adjustments are common for pharmaceuticals to compensate for regulatory review delays.
  • European Patent EP1172370B1: Covers the olaparib compound in Europe. Similar to the US patent, its basic term would have expired, but PTEs could extend its effective market exclusivity in various European countries.

• Formulation Patents:

  • Patents covering specific oral formulations of olaparib, such as film-coated tablets (e.g., Lynparza tablets). These patents often have later expiration dates than the compound patent and can extend market exclusivity for the branded product. For instance, formulation patents can extend protection for 20 years from the filing date, with potential adjustments.

• Method of Use Patents:

  • Patents claiming the use of olaparib for treating specific cancers, particularly those with BRCA mutations. These patents are crucial for protecting the therapeutic application and can also have later expiry dates. For example, a patent filed in 2005 for a specific use might have an expiration around 2025, before accounting for PTEs.

Anticipated Generic Entry:

The expiration of key composition of matter and use patents signals the potential for generic olaparib market entry.

• US Market: Generic competition is likely to intensify as patents expire or are successfully challenged. The first generic olaparib applications would typically be filed once the relevant patents are nearing or have expired.
• European Markets: Similar to the US, generic entry is contingent on patent expiry in individual member states and any applicable Supplementary Protection Certificates (SPCs).
• Other Major Markets (e.g., Japan, Canada): Patent landscapes and regulatory exclusivities vary, requiring country-specific analysis.

Companies developing generic olaparib often conduct extensive patent analysis and may engage in Paragraph IV certifications in the US to challenge existing patents, potentially accelerating generic entry.

What is the Regulatory Status and Impact on Supply Chains?

The approval and ongoing monitoring of olaparib by regulatory bodies worldwide significantly impact its supply chain.

• US Food and Drug Administration (FDA): The FDA approval pathway for olaparib (e.g., for ovarian, breast, prostate, pancreatic cancers) dictates manufacturing standards and post-market surveillance. The FDA's Orange Book lists approved drugs and patent information, crucial for generic manufacturers.
• European Medicines Agency (EMA): Similar to the FDA, the EMA's approval and ongoing pharmacovigilance ensure drug safety and efficacy. The EMA's database also provides information on authorized medicines.
• Good Manufacturing Practices (GMP): All manufacturing facilities involved in producing olaparib API and finished drug products must adhere to strict GMP standards mandated by regulatory authorities. Audits and inspections by these bodies are regular occurrences.
• Supply Chain Security and Quality Control: Robust quality control measures and supply chain security are paramount to prevent counterfeiting and ensure product integrity. Regulatory scrutiny extends to the sourcing of raw materials and intermediates.

Any disruption in the regulatory compliance of a key supplier can have a material impact on the availability of olaparib.

Who are the Potential Generic Manufacturers?

As patents for olaparib approach expiration, generic pharmaceutical companies are positioning themselves for market entry. These companies typically focus on cost-effective API synthesis and navigating the complex regulatory approval process.

• Sun Pharmaceutical Industries Ltd. (India): A major global player in generics with significant expertise in oncology drugs.
• Dr. Reddy's Laboratories Ltd. (India): Another prominent Indian generic company with a broad portfolio and R&D capabilities.
• Teva Pharmaceutical Industries Ltd. (Israel): A leading generic drug manufacturer with a global presence.
• Viatris Inc. (USA): Formed by the merger of Mylan and Pfizer's Upjohn business, Viatris has a substantial generic portfolio.
• Zydus Lifesciences Ltd. (India): Active in developing and manufacturing complex generics.

These companies will rely on CDMOs for API manufacturing or may have in-house capabilities. Their success hinges on patent non-infringement strategies and efficient production.

What are the Key Considerations for Investment and R&D?

Several factors are critical for evaluating investment and R&D opportunities related to olaparib.

• Patent Expiration and Generic Competition: The timeline for patent expiry directly influences the window of market exclusivity for the originator and the potential for generic market share. Early identification of patent expiry dates and potential litigation is vital.
• API Manufacturing Costs and Scalability: The cost of API synthesis and the ability of suppliers to scale production are key determinants of profitability for both originator and generic products. Diversification of API suppliers can mitigate risks.
• Therapeutic Indications Expansion: Ongoing clinical trials exploring new indications for olaparib can expand the drug's market potential and create new revenue streams for the originator and opportunities for generics in those new indications.
• Emerging Markets: Assessing the regulatory pathways and market access in emerging economies can reveal significant growth opportunities for olaparib, both branded and generic.
• Combination Therapies: Research into combining olaparib with other cancer therapies can lead to enhanced efficacy and new treatment protocols, impacting the drug's long-term market position.

Understanding the interplay between patent law, manufacturing capabilities, and clinical development is essential for strategic decision-making.

Key Takeaways

The olaparib supply chain involves specialized API manufacturers and CDMOs, with AstraZeneca as the originator. Key intermediates are critical components, and their sourcing requires careful consideration. The intellectual property landscape, characterized by foundational compound patents and later-expiring formulation and method-of-use patents, dictates the timeline for generic market entry. Major generic manufacturers are poised to enter the market following patent expiries. Investment and R&D strategies must account for patent cliffs, manufacturing costs, evolving therapeutic indications, and global market dynamics. Regulatory compliance is a non-negotiable factor impacting all aspects of the supply chain.

Frequently Asked Questions

1. How is the supply chain for olaparib API typically structured?

The supply chain for olaparib API is typically structured with the originator company, AstraZeneca, overseeing a network of qualified Contract Development and Manufacturing Organizations (CDMOs). These CDMOs are responsible for the multi-step synthesis of the active pharmaceutical ingredient. In anticipation of patent expiries, generic drug manufacturers also establish relationships with CDMOs or develop their own in-house manufacturing capabilities for olaparib API and its key intermediates.

2. What are the main risks associated with the olaparib supply chain?

Key risks include the reliance on a limited number of specialized API manufacturers and intermediate suppliers, potential quality control failures leading to regulatory non-compliance, geopolitical instability affecting raw material sourcing or manufacturing operations, and intellectual property disputes that could delay or prevent generic market entry.

3. How does patent expiration impact the pricing of olaparib?

Following the expiration of key patents and the subsequent entry of generic competitors, the pricing of olaparib is expected to decrease significantly. Generic manufacturers typically achieve lower production costs through optimized synthesis routes and economies of scale, allowing them to offer the drug at substantially lower prices compared to the originator's branded product.

4. What are the primary hurdles for a generic manufacturer seeking to launch olaparib?

Primary hurdles include navigating complex patent landscapes and potential litigation from the originator (e.g., Paragraph IV certifications in the US), securing reliable and cost-effective API manufacturing, demonstrating bioequivalence to the branded product, and obtaining regulatory approval from health authorities like the FDA and EMA.

5. Are there any specific requirements for manufacturing olaparib intermediates?

Manufacturing olaparib intermediates, like the API itself, requires adherence to stringent Good Manufacturing Practices (GMP) as mandated by regulatory agencies. This includes rigorous quality control, detailed documentation of processes, validated analytical methods for purity and identity testing, and robust supply chain traceability to ensure the integrity and safety of the final drug product.

Citations

[1] United States Patent and Trademark Office. (2002). US Patent 6,498,155 B1. Retrieved from USPTO database. [2] European Patent Office. (n.d.). European Patent EP1172370B1. Retrieved from Espacenet database. [3] U.S. Food and Drug Administration. (n.d.). Orphan Drug Designations. Retrieved from FDA website. [4] European Medicines Agency. (n.d.). European Public Assessment Reports (EPARs). Retrieved from EMA website.