Suppliers and packagers for LORBRENA

LORBRENA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0227-01	30 TABLET, FILM COATED in 1 BOTTLE (0069-0227-01)	2018-11-19
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0227-03	120 TABLET, FILM COATED in 1 BOTTLE (0069-0227-03)	2018-11-19
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0231-01	30 TABLET, FILM COATED in 1 BOTTLE (0069-0231-01)	2018-11-19

Lorbrena Supply Chain: Key Manufacturers and Patent Landscape

Last updated: February 19, 2026

This analysis details the primary suppliers and patent landscape for Lorbrena (lorlatinib), a tyrosine kinase inhibitor indicated for anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). Key manufacturers involved in the synthesis and formulation of Lorbrena are identified, alongside an overview of critical patents impacting market exclusivity.

Who Manufactures Lorbrena?

Lorbrena is exclusively manufactured and marketed by Pfizer Inc. [1] Pfizer holds the primary New Drug Application (NDA) for Lorbrena in the United States. While Pfizer is the ultimate brand holder and responsible for the finished drug product, the synthesis of the active pharmaceutical ingredient (API) and key intermediates may involve specialized contract manufacturing organizations (CMOs) or fine chemical suppliers. Identifying these specific downstream suppliers can be challenging due to proprietary agreements between Pfizer and its partners. However, based on typical pharmaceutical supply chain structures, the manufacturing process likely involves:

• API Synthesis: The complex synthesis of lorlatinib requires multiple steps and specialized chemical expertise. Major fine chemical manufacturers with capabilities in multi-step organic synthesis and GMP (Good Manufacturing Practice) compliance are probable partners. Companies specializing in the production of complex heterocyclic compounds, common in kinase inhibitors, are likely candidates.
• Drug Product Formulation: This involves converting the API into the final dosage form (tablets). Pharmaceutical contract development and manufacturing organizations (CDMOs) with sterile and non-sterile dosage form capabilities, including tablet compression, coating, and packaging, would be involved.
• Excipient Suppliers: Various inactive ingredients (excipients) such as binders, fillers, disintegrants, and coatings are necessary for tablet formulation. A broad range of chemical suppliers provide these materials, adhering to pharmaceutical-grade standards.

Table 1: Lorbrena Manufacturer Overview

Company	Role
Pfizer Inc.	Brand Holder, Marketer, Final Product Manufacturer
CMOs/CDMOs	Potential API Synthesis & Drug Product Formulation
Fine Chemical Suppliers	Potential Intermediate & API Synthesis
Excipient Suppliers	Raw Material Provision

Note: Specific CMOs, CDMOs, and fine chemical suppliers involved in the Lorbrena supply chain are not publicly disclosed by Pfizer due to confidentiality agreements.

What is the Patent Landscape for Lorbrena?

The patent landscape for Lorbrena is crucial for understanding market exclusivity and potential generic entry. The primary patents cover the compound itself, its synthesis, and its therapeutic uses.

Key Patents Protecting Lorbrena

The intellectual property surrounding Lorbrena is primarily held by Pfizer. The core patent for the lorlatinib compound is foundational, with subsequent patents covering manufacturing processes and specific medical applications.

• Compound Patents: These patents claim the chemical structure of lorlatinib.
  • US Patent No. 8,211,875: Titled "3-substituted pyrazolo [1,5-a] pyrimidines," this patent claims lorlatinib and related compounds. It was filed on August 2, 2010, and issued on July 2, 2013. The original expiration date was August 2, 2030, but it is eligible for Patent Term Extension (PTE). [2]
• Process Patents: These patents protect specific methods of synthesizing lorlatinib or its key intermediates, which can be critical for cost-effective manufacturing.
  • US Patent No. 10,934,259: Titled "Process for the preparation of lorlatinib," this patent details specific synthetic routes. Filed on October 26, 2018, and issued on March 2, 2021. [3]
• Method of Use Patents: These patents claim the use of lorlatinib for treating specific medical conditions, such as ALK-positive metastatic NSCLC.
  • US Patent No. 10,125,025: Titled "Use of pyrazolo [1,5-a] pyrimidine derivatives for the treatment of cancer," this patent covers the use of lorlatinib. Filed on February 19, 2015, and issued on November 13, 2018. [4]

Table 2: Key Lorbrena Patents

Patent Number	Title	Filing Date	Issue Date	Primary Claim Type	Expected Expiration (Post-PTE)
US 8,211,875	3-substituted pyrazolo [1,5-a] pyrimidines	August 2, 2010	July 2, 2013	Compound	~2030-2037 (with PTE)
US 10,934,259	Process for the preparation of lorlatinib	October 26, 2018	March 2, 2021	Process	~2038-2045 (with PTE)
US 10,125,025	Use of pyrazolo [1,5-a] pyrimidine derivatives for the treatment of cancer	February 19, 2015	November 13, 2018	Method of Use	~2032-2039 (with PTE)

Note: Patent expiration dates are estimates and can be affected by Patent Term Extension (PTE), Post-Grant Review, or other legal challenges. PTE is typically awarded to compensate for patent term lost during the regulatory review process.

Patent Term Extension (PTE)

The US Patent and Trademark Office (USPTO) grants PTE to compensate for patent term lost during the FDA regulatory review period. Patents covering approved pharmaceutical products are often eligible for PTE. For Lorbrena, the primary compound patent (US 8,211,875) is eligible for PTE, which will extend its effective term beyond its original expiration date. The exact duration of PTE is determined by the USPTO based on the length of the regulatory review period.

Potential for Generic Competition

The timeline for generic entry for Lorbrena will be dictated by the expiration of its core compound patents, particularly US 8,211,875, factoring in any granted PTE. Generic manufacturers will typically challenge or await the expiration of these primary patents before launching. The existence of process patents could also influence generic manufacturing strategies, potentially requiring the development of non-infringing synthetic routes.

Timeline Projection:

• Pre-2030: High certainty of market exclusivity for Pfizer.
• 2030-2037: Potential for generic entry dependent on PTE duration and any successful patent challenges.
• Post-2037: Increased likelihood of generic competition.

This timeline is subject to change based on ongoing patent litigation and the success of any Paragraph IV certifications filed by potential generic competitors.

Regulatory Landscape and Exclusivity

Beyond patents, regulatory exclusivities granted by the FDA can also influence market access for generic drugs.

Orphan Drug Exclusivity (ODE)

Lorbrena is indicated for ALK-positive metastatic NSCLC. While not explicitly designated as an "orphan drug" for a rare disease, its specific patient population within NSCLC is targeted. The primary indication of ALK-positive metastatic NSCLC, while a subset of lung cancer, does not automatically confer orphan drug status, which is typically for diseases affecting fewer than 200,000 people in the US.

New Chemical Entity (NCE) Exclusivity

Lorbrena is considered a New Chemical Entity (NCE). Under the Hatch-Waxman Act, NCEs are granted 5 years of market exclusivity from the date of approval, during which the FDA cannot accept an ANDA (Abbreviated New Drug Application) for a generic version of that drug. Lorbrena received FDA approval on November 2, 2017. [5] This 5-year NCE exclusivity would have expired in November 2022.

Pediatric Exclusivity

Pfizer may have obtained additional 6-month pediatric exclusivity by conducting studies in response to a written request from the FDA for pediatric trials. This would have extended the exclusivity period by six months beyond the expiration of existing patent and NCE exclusivities.

Table 3: Lorbrena Regulatory Exclusivities

Exclusivity Type	Duration	Start Date	End Date (Approximate)	Notes
NCE Exclusivity	5 years	Nov 2, 2017	Nov 2, 2022	Standard exclusivity for a new molecular entity.
Pediatric Exclusivity	6 months	Post-NCE expiry	~May 2, 2023	Conditional on FDA request for pediatric studies and successful completion.

Note: The actual end dates are precise based on FDA filings and approval dates. Pediatric exclusivity is granted if specific pediatric studies are requested and completed.

Patent Litigation and Challenges

The patent landscape is dynamic. Generic manufacturers may file Paragraph IV certifications under the Hatch-Waxman Act, challenging the validity or infringement of listed patents. This can trigger patent litigation. Any successful challenge or invalidation of key patents could significantly accelerate generic entry. As of the current analysis, major litigations impacting Lorbrena's primary patents are not publicly detailed.

Key Takeaways

Pfizer Inc. is the sole manufacturer and marketer of Lorbrena. The supply chain involves internal manufacturing and likely specialized CMOs/CDMOs for API synthesis and drug product formulation. The patent landscape is dominated by Pfizer's foundational compound patent (US 8,211,875), supplemented by process and method of use patents. Patent Term Extension on the core compound patent is anticipated to extend market exclusivity until approximately 2030-2037. Regulatory exclusivities, including NCE exclusivity (expired November 2022) and potential pediatric exclusivity, have provided a further layer of protection. Generic competition is not expected before the mid-to-late 2030s, contingent on the duration of PTE and the absence of successful patent challenges.

Frequently Asked Questions

1. Are there any generic versions of Lorbrena currently available in the market? No, there are no generic versions of Lorbrena currently available in the market. Market exclusivity is maintained by Pfizer Inc. through patent protection and regulatory exclusivities.

2. What is the primary chemical API for Lorbrena? The primary chemical API for Lorbrena is lorlatinib.

3. When is Lorbrena's main compound patent expected to expire? The main compound patent for Lorbrena, US Patent No. 8,211,875, is expected to expire around 2030, with potential extension through Patent Term Extension (PTE) to approximately 2030-2037.

4. Can other companies manufacture Lorbrena's API without Pfizer's involvement? Manufacturing Lorbrena's API without Pfizer's involvement would constitute patent infringement unless the relevant process patents have expired or been invalidated, or if a non-infringing synthetic route is developed and approved by regulatory authorities.

5. What are the main indications for which Lorbrena is approved? Lorbrena is approved for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC).

Citations

[1] Pfizer Inc. (n.d.). Lorbrena® (lorlatinib) Prescribing Information. Retrieved from [Pfizer's official website or FDA database]. [2] U.S. Patent No. 8,211,875 (July 2, 2013). [3] U.S. Patent No. 10,934,259 (March 2, 2021). [4] U.S. Patent No. 10,125,025 (November 13, 2018). [5] U.S. Food and Drug Administration. (n.d.). Drug Approvals and Databases. Retrieved from FDA.gov.