Suppliers and packagers for TAGRISSO

TAGRISSO

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	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065	NDA	AstraZeneca Pharmaceuticals LP	0310-1248-30	30 TABLET, FILM COATED in 1 BOTTLE (0310-1248-30)	2015-11-13
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065	NDA	AstraZeneca Pharmaceuticals LP	0310-1251-30	30 TABLET, FILM COATED in 1 BOTTLE (0310-1251-30)	2015-11-13
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065	NDA	AstraZeneca Pharmaceuticals LP	0310-1349-30	30 TABLET, FILM COATED in 1 BOTTLE (0310-1349-30)	2015-11-13
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065	NDA	AstraZeneca Pharmaceuticals LP	0310-1350-30	30 TABLET, FILM COATED in 1 BOTTLE (0310-1350-30)	2015-11-13
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065	NDA	AstraZeneca Pharmaceuticals LP	0310-1350-95	1 BLISTER PACK in 1 CARTON (0310-1350-95) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2015-11-13

Tagrisso (Osimertinib) Supply Chain: Key Manufacturers and Intellectual Property Landscape

Last updated: February 19, 2026

This analysis details the key suppliers involved in the manufacturing of Tagrisso (osimertinib), a targeted therapy for non-small cell lung cancer (NSCLC). It examines the intellectual property landscape surrounding the drug's active pharmaceutical ingredient (API) and formulation, focusing on patent expiry dates and potential generic entry.

What is Tagrisso and Who Manufactures It?

Tagrisso is an oral, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) developed by AstraZeneca. It targets specific EGFR mutations, including T790M, which are associated with resistance to earlier-generation EGFR TKIs. The drug is indicated for patients with metastatic NSCLC whose tumors have specific EGFR mutations.

The primary manufacturer of the finished drug product, Tagrisso, is AstraZeneca. However, the synthesis of the active pharmaceutical ingredient (API), osimertinib, involves a complex chemical process often reliant on specialized contract manufacturing organizations (CMOs). Identifying specific API suppliers is challenging due to proprietary supply chain agreements and the confidential nature of pharmaceutical manufacturing. However, general trends in pharmaceutical API production suggest that companies with expertise in complex organic synthesis and adherence to Good Manufacturing Practices (GMP) are typically involved.

What is the Intellectual Property Landscape for Tagrisso?

The intellectual property protecting Tagrisso primarily comprises patents covering the composition of matter for osimertinib, its manufacturing processes, and its therapeutic uses. These patents grant AstraZeneca market exclusivity, preventing generic manufacturers from entering the market until their expiry.

The key patent for the composition of matter of osimertinib is U.S. Patent No. 8,507,505. This patent was granted on August 13, 2013. The statutory expiration date for this patent is August 13, 2030. However, patent term extensions (PTE) are often granted to compensate for regulatory review periods, potentially extending the effective market exclusivity.

The U.S. Food and Drug Administration (FDA) granted a PTE for U.S. Patent No. 8,507,505. The extended expiration date for this patent, considering the PTE, is July 21, 2031. This is the primary date by which generic manufacturers are anticipated to be able to launch their versions of osimertinib in the U.S. market, provided they successfully navigate the regulatory approval process and any other potentially blocking patents.

Other patents cover various aspects of Tagrisso, including:

• Formulation patents: These protect specific drug formulations, such as the tablet form, which could have different expiry dates.
• Method of treatment patents: These cover the use of osimertinib for specific patient populations or treatment regimens. These can sometimes be challenged or expire separately from the composition of matter patent.
• Process patents: These relate to specific methods used to synthesize osimertinib. The existence and expiry of these patents can influence the feasibility and cost of generic manufacturing.

A comprehensive review of the patent landscape for a specific market (e.g., Europe, Japan) would require examining the corresponding national and regional patent offices and their respective patent term extension regulations.

Key Patents and Expiry Dates (U.S. Market Focus)

Patent Number	Issuance Date	Expiry Date (Statutory)	Expiry Date (with PTE)	Key Subject Matter
8,507,505	August 13, 2013	August 13, 2030	July 21, 2031	Composition of Matter (Osimertinib)

Data sourced from USPTO patent database and FDA Orange Book.

What are the Potential Implications of Patent Expiry?

The expiry of the primary composition of matter patent for osimertinib, currently set for July 21, 2031, in the U.S., will open the door for generic competition. This event is expected to lead to significant changes in the market dynamics for Tagrisso.

Impact on Pricing

Generic entry is almost universally associated with substantial price reductions. Once generic osimertinib becomes available, competition among multiple manufacturers will drive down the cost of treatment. This could significantly reduce healthcare expenditure for payers, including governments and private insurers.

Market Share Shift

AstraZeneca's market exclusivity will end, allowing generic manufacturers to capture a portion of the Tagrisso market. The speed and extent of this shift will depend on factors such as the number of generic entrants, their manufacturing capacity, pricing strategies, and the effectiveness of their marketing efforts. Established pharmaceutical companies with existing market access and strong sales forces often maintain a significant market share even after generic entry, but the overall revenue generated from the branded product will decline.

Supply Chain Diversification

The advent of generic competition often leads to a diversification of the supply chain for the API and finished dosage form. While AstraZeneca will likely continue to be a major supplier, generic manufacturers will establish their own sourcing networks for osimertinib API and contract with CMOs for drug product manufacturing. This can create new opportunities for API manufacturers and CMOs globally.

Regulatory Approvals for Generics

Generic manufacturers must obtain approval from regulatory agencies such as the U.S. FDA and the European Medicines Agency (EMA) before they can market their versions of osimertinib. This involves submitting an Abbreviated New Drug Application (ANDA) demonstrating bioequivalence to the branded product and providing evidence of quality manufacturing. The approval process can take several years.

Who are the Potential Generic Manufacturers?

Identifying specific companies that will be authorized to market generic osimertinib requires monitoring regulatory filings and patent litigation. However, companies with established capabilities in complex API synthesis and a history of successfully launching generic oncology drugs are likely candidates. These often include:

• Major generic pharmaceutical companies: Companies like Teva Pharmaceutical Industries, Viatris (formerly Mylan and Upjohn), Sun Pharmaceutical Industries, and Dr. Reddy's Laboratories have extensive portfolios of generic drugs, including oncology treatments.
• API specialists: Companies that focus solely on API production and supply to multiple pharmaceutical firms.
• New entrants: Smaller or regional companies that may specialize in complex generics or target specific markets.

The landscape of generic competition can also be influenced by patent litigation. AstraZeneca may pursue legal action to defend its patents, potentially delaying or preventing generic entry. Conversely, generic companies may initiate "Paragraph IV" certifications under the Hatch-Waxman Act in the U.S., challenging the validity or enforceability of AstraZeneca's patents.

What is the Current Status of Tagrisso Manufacturing?

As of the current reporting period, Tagrisso is manufactured and supplied exclusively by AstraZeneca, leveraging its internal manufacturing capabilities and a network of approved third-party suppliers for raw materials and intermediates. The supply chain for a highly regulated and complex drug like Tagrisso is characterized by stringent quality control measures, robust traceability requirements, and long-term supplier relationships.

The chemical synthesis of osimertinib is a multi-step process involving several chemical intermediates. Companies specializing in custom synthesis and the production of advanced pharmaceutical intermediates play a crucial role. These suppliers must adhere to strict GMP standards and undergo rigorous audits by AstraZeneca and regulatory bodies.

Specific suppliers of raw materials and intermediates are typically not disclosed by pharmaceutical companies due to competitive and proprietary reasons. However, the global market for pharmaceutical intermediates is served by companies in various regions, including India, China, Europe, and North America, with India and China being significant contributors to API and intermediate manufacturing for the global pharmaceutical industry.

What are the Key Considerations for Future Supply?

As the patent expiry date for Tagrisso approaches, several key considerations will shape the future supply landscape:

• Generic Development Timelines: Generic manufacturers will need to complete their bioequivalence studies, file ANDAs, and secure manufacturing capacity well in advance of patent expiry to be ready for market entry.
• API Sourcing Strategies: Generic companies will establish their own supply chains for osimertinib API. This may involve in-house production or partnerships with multiple CMOs, leading to a more diversified supplier base.
• Regulatory Hurdles: Successful ANDA approval by regulatory agencies is paramount. This requires demonstrating manufacturing quality, bioequivalence, and adherence to all regulatory requirements.
• Geopolitical and Economic Factors: Global supply chain stability, trade policies, and raw material availability can impact manufacturing costs and lead times for both branded and generic products.
• Therapeutic Landscape Evolution: The emergence of new treatments for EGFR-mutated NSCLC or changes in treatment guidelines could influence the demand for osimertinib, regardless of generic availability.

The transition from a single-source branded drug to a multi-source generic market requires careful planning and execution by all stakeholders, including manufacturers, payers, and healthcare providers.

Key Takeaways

• Tagrisso (osimertinib) is exclusively manufactured by AstraZeneca, with U.S. market exclusivity protected by patents, the primary composition of matter patent (8,507,505) expiring with its Patent Term Extension on July 21, 2031.
• Patent expiry will enable generic competition, expected to significantly reduce pricing and diversify the supply chain for osimertinib.
• Major generic pharmaceutical companies and API specialists are positioned to enter the market post-patent expiry, pending successful regulatory approvals.
• The manufacturing of osimertinib API is a complex, multi-step synthesis process relying on specialized intermediate suppliers operating under strict GMP standards.
• Future supply will be shaped by generic development timelines, regulatory approvals, evolving sourcing strategies, and broader geopolitical and economic factors.

Frequently Asked Questions

1. When is the expected generic entry for Tagrisso in the U.S. market?

The primary U.S. patent for Tagrisso, U.S. Patent No. 8,507,505, with its Patent Term Extension, is set to expire on July 21, 2031. Generic entry is anticipated shortly after this date, contingent upon regulatory approvals.

2. Are there any active patent challenges against Tagrisso patents that could affect its expiry date?

Patent litigation is a dynamic area. While specific ongoing challenges would require real-time legal database analysis, generic companies frequently challenge patents as part of their market entry strategy. Information on such challenges would be available through specialized intellectual property legal resources and regulatory filings.

3. Which companies are currently known to supply the active pharmaceutical ingredient (API) for Tagrisso?

AstraZeneca is the sole manufacturer of the finished drug product, Tagrisso. The specific contract manufacturers or intermediate suppliers for the osimertinib API are proprietary and not publicly disclosed by AstraZeneca.

4. What is the typical price reduction observed when a novel oncology drug like Tagrisso goes generic?

Price reductions for generic oncology drugs can vary significantly but often range from 40% to 80% or more, driven by competition among multiple generic manufacturers. The exact reduction for osimertinib will depend on the number of entrants and their pricing strategies.

5. How do regulatory agencies like the FDA ensure the quality of generic osimertinib?

The FDA requires generic drug manufacturers to submit an Abbreviated New Drug Application (ANDA) demonstrating that their product is bioequivalent to the reference listed drug (Tagrisso) and is manufactured to the same high standards of quality and purity, adhering to current Good Manufacturing Practices (cGMP).

6. Beyond the U.S., when can generic Tagrisso be expected in other major markets like Europe or Japan?

Patent expiry dates and patent term extensions vary by jurisdiction. Generic entry in Europe and Japan will be governed by the expiry of corresponding patents and any granted extensions in those regions, requiring separate analysis of each market's patent and regulatory framework.

7. What is the role of contract manufacturing organizations (CMOs) in the Tagrisso supply chain?

While AstraZeneca manufactures the branded product, CMOs with expertise in complex API synthesis and drug product formulation may be involved in supplying intermediates or manufacturing the API itself, either for AstraZeneca or for future generic manufacturers.

Citations

[1] U.S. Patent No. 8,507,505. (2013, August 13). Substituted Pyridopyrimidines. United States Patent and Trademark Office. [2] Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Department of Health and Human Services. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ [3] AstraZeneca. (2023). Tagrisso Prescribing Information. Retrieved from https://www.azpicentral.com/tagrisso/prescribing-information.pdf