Suppliers and packagers for daurismo

daurismo

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	DAURISMO	glasdegib maleate	TABLET;ORAL	210656	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0298-60	60 TABLET, FILM COATED in 1 BOTTLE (0069-0298-60)	2018-12-10
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656	NDA	Pfizer Laboratories Div Pfizer Inc	0069-1531-30	30 TABLET, FILM COATED in 1 BOTTLE (0069-1531-30)	2018-12-10

Suppliers for the Pharmaceutical Drug: Daurismo (Glasdegib)

Last updated: July 27, 2025

Introduction

Daurismo (generic name: glasdegib) is a targeted therapy approved by the U.S. Food and Drug Administration (FDA) for treating acute myeloid leukemia (AML) in adult patients who are unfit for intensive chemotherapy. As a first-in-class Smoothened (SMO) inhibitor, glasdegib interferes with the Hedgehog signaling pathway involved in cancer stem cell maintenance and proliferation (1). Since its approval, the supply chain for Daurismo has become a critical focus for healthcare providers, pharmaceutical distributors, and generic manufacturers aiming to ensure consistent patient access. This article provides a comprehensive overview of the current suppliers for Daurismo, analyzing manufacturing landscape, licensing agreements, and the potential for genericization.

---

Manufacturers of Daurismo (Glasdegib)

1. Originator Company: Pfizer Inc.

Pfizer developed and holds the original patent rights for glasdegib. The company's dedicated manufacturing facilities produce Daurismo as a proprietary, branded medication. Pfizer’s global supply chain expansion encompasses multiple manufacturing sites, leveraging their extensive pharmaceutical infrastructure to meet domestic and international demand (2).

2. Manufacturing Facilities

Pfizer operates several high-volume biologics and small-molecule manufacturing plants worldwide, with manufacturing capabilities for glasdegib primarily concentrated in their U.S. and European facilities. These plants maintain strict Good Manufacturing Practice (GMP) standards to ensure quality and regulatory compliance.

3. Commercial Supply Sources

Currently, Pfizer is the sole commercial supplier of Daurismo in the United States and several other markets. The drug is distributed through established channels, including hospital systems, specialty pharmacies, and authorized distributors (3).

---

Generic and Biosimilar Landscape for Daurismo

1. Patent Status and Market Exclusivity

The patent lifecycle for glasdegib imposes a significant barrier for generics and biosimilars. Pfizer’s patents covering the composition, manufacturing process, and method of use provide exclusivity generally lasting until at least 2030 in key jurisdictions. However, patent challenges or expiry could open pathways for generic manufacturers.

2. Opportunities for Generic Development

Given glasdegib’s small-molecule nature, generic development is feasible once patent barriers expire. To date, no generic manufacturers have launched glasdegib biosimilars or generics, primarily due to:

• Patent protections
• Complexity of manufacturing
• Limited market size compared to blockbuster drugs

3. Potential Future Suppliers

Potential future suppliers could include:

• Molecular generic manufacturers: Companies specializing in small-molecule biosourcing may seek FDA approval to produce generic glasdegib. Firms like Teva, Sun Pharma, and Dr. Reddy’s are active in similar indications and possess the technical capacity to develop such agents (4).

• Contract development and manufacturing organizations (CDMOs): These entities might produce glasdegib under licensing agreements for generic firms once patents expire.

4. Licensing and Collaboration Agreements

In some cases, patent holders like Pfizer may license manufacturing rights to third parties, facilitating the entry of generic or biosimilar versions in emerging markets or under different regulatory pathways. So far, no such agreements for glasdegib have been publicly announced.

---

Regulatory and Market Dynamics

1. Regulatory Pathways

For generics, the abbreviated new drug application (ANDA) process in the U.S. and bioequivalence studies are required for approval. Given glasdegib’s mechanism and chemical structure, these pathways are straightforward once patent barriers are lifted, assuming manufacturing quality standards are met (5).

2. Market Factors Influencing Supplier Availability

• Market demand: AML remains a specialized niche but with a growing patient base in aging populations.
• Pricing and affordability: Pfizer’s pricing strategy and formulary placement influence market entry by generics.
• Regulatory environment: Patent disputes or extensions could delay generic entry.

---

Supply Chain Challenges and Risks

While Pfizer maintains tight control over glasdegib manufacturing, potential risks include:

• Production disruptions stemming from GMP violations or supply chain bottlenecks.
• Regulatory delays impeding approval of potential generics post-patent expiry.
• Competition in international markets due to local manufacturing or licensing agreements.

---

Conclusion

Currently, Pfizer is the exclusive supplier of Daurismo (glasdegib), leveraging its manufacturing infrastructure and patent protections. The landscape remains open for generic rivals pending patent expiry and regulatory approval processes. Companies with capabilities in small-molecule manufacturing and existing biosimilar experience could emerge as future suppliers, especially in regions where patent protections diminish. Stakeholders should monitor patent statuses, market dynamics, and regulatory developments to anticipate supplier shifts effectively.

---

Key Takeaways

• Pfizer is the primary and sole supplier of Daurismo, with robust manufacturing infrastructure supporting global distribution.
• Patent protections currently restrict generic entry, but opportunities may arise post-2030.
• The small-molecule nature of glasdegib offers a feasible pathway for biosimilar development once patents expire.
• Future supply stability depends on patent litigation outcomes, manufacturing capacity, and regulatory approvals.
• Strategic licensing and partnerships may influence future supplier landscapes in different markets.

---

FAQs

1. Who currently manufactures Daurismo (glasdegib)?
Pfizer Inc. holds exclusive manufacturing rights and supplies Daurismo through its global distribution network.

2. Are generic versions of glasdegib available on the market?
No, there are no approved generics. Patent protections and market considerations are primary barriers.

3. When will patents for glasdegib expire, allowing for generic development?
Patent expiry in the U.S. is expected around 2030, subject to legal challenges and patent term extensions.

4. What companies might become future suppliers of glasdegib?
Potential future suppliers include generic manufacturers like Teva, Sun Pharma, and others capable of small-molecule production, pending patent expiration.

5. How can healthcare providers ensure a stable supply of Daurismo?
By maintaining relationships with Pfizer or authorized distributors, monitoring patent statuses, and preparing for potential biosimilar entries post-patent expiration.

---

References

1. U.S. Food and Drug Administration. Daurismo (glasdegib) prescribing information. 2018.
2. Pfizer Inc. Annual Report 2022. Pfizer’s manufacturing and supply chain overview.
3. IQVIA. Global Oncology Trends Report 2022.
4. PhRMA. Industry Report on Small-Molecule Biosimilars and Generics. 2022.
5. FDA. ANDA Guidance for Small Molecules. 2021.