Suppliers and packagers for XELJANZ

XELJANZ

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214	NDA	Pfizer Laboratories Div Pfizer Inc	0069-1001-01	60 TABLET, FILM COATED in 1 BOTTLE (0069-1001-01)	2012-11-09
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214	NDA	Pfizer Laboratories Div Pfizer Inc	0069-1002-01	60 TABLET, FILM COATED in 1 BOTTLE (0069-1002-01)	2018-07-02
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214	NDA	U.S. Pharmaceuticals	63539-012-02	60 TABLET, FILM COATED in 1 BOTTLE (63539-012-02)	2012-11-08
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214	NDA	U.S. Pharmaceuticals	63539-016-02	60 TABLET, FILM COATED in 1 BOTTLE (63539-016-02)	2018-07-02
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082	NDA	Pfizer Laboratories Div Pfizer Inc	0069-1029-02	1 BOTTLE in 1 CARTON (0069-1029-02) / 240 mL in 1 BOTTLE (0069-1029-01)	2021-02-08

Suppliers for the Pharmaceutical Drug Xeljanz: A Comprehensive Analysis

Xeljanz (tofacitinib), a Janus kinase (JAK) inhibitor developed by Pfizer Inc., has become a cornerstone therapy for autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis[1][9]. Since its FDA approval in 2012, the drug’s supply chain has evolved to encompass a network of manufacturers, distributors, wholesalers, and pharmacies. This report examines the key suppliers involved in the production and distribution of Xeljanz, focusing on Pfizer’s role as the innovator, active pharmaceutical ingredient (API) suppliers, distribution partners, and retail channels. The analysis also highlights recent regulatory and policy changes impacting Xeljanz’s availability, including Pfizer’s Defined Distribution system for 340B entities and shifts in international distribution agreements.

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Pfizer Inc.: The Innovator and Primary Manufacturer

Development and Regulatory Approvals

Pfizer Inc., headquartered in New York, NY, holds exclusive rights to manufacture and market Xeljanz globally[1][9]. The drug’s approval trajectory began in 2012 with its initial indication for rheumatoid arthritis[1]. Subsequent expansions include approvals for psoriatic arthritis (2017), ulcerative colitis (2018), ankylosing spondylitis (2021 in the EU)[2], and polyarticular juvenile idiopathic arthritis (2020)[8]. These milestones underscore Pfizer’s vertical integration in Xeljanz’s production, from research and development to commercialization.

Manufacturing Facilities and Formulations

Pfizer produces multiple formulations of Xeljanz, including immediate-release tablets (5 mg, 10 mg), extended-release tablets (11 mg, 22 mg), and an oral solution (1 mg/mL)[4][6]. Manufacturing occurs at Pfizer-owned facilities in the U.S., such as Groton, Connecticut, and La Jolla, California, as well as international sites in the UK and India[9][15]. The company’s Chennai, India facility plays a critical role in API synthesis, ensuring global supply chain resilience[9].

Patent Protections and Market Exclusivity

As the patent holder, Pfizer maintains exclusivity over Xeljanz in most markets until 2025–2030, depending on regional regulations[9]. This exclusivity has allowed Pfizer to establish a near-monopoly on branded tofacitinib, though generic alternatives are emerging in regions with expired patents. For example, India’s Hetero Drugs and Hunan Huateng Pharmaceutical Co. Ltd. produce generic tofacitinib citrate API, signaling future competition[6][14].

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Active Pharmaceutical Ingredient (API) Suppliers

Pfizer’s In-House API Production

Pfizer synthesizes tofacitinib citrate in-house at its Chennai facility, ensuring tight quality control and regulatory compliance[9]. This vertical integration minimizes dependency on third-party suppliers, though the company collaborates with contract manufacturers for secondary production steps.

Third-Party API Manufacturers

Globally, over 50 companies are authorized to produce tofacitinib citrate API under licensing agreements with Pfizer. Key suppliers include:

• Hetero Drugs (India): A leading generic pharmaceutical company producing API for emerging markets[6][14].
• Hunan Huateng Pharmaceutical Co. Ltd. (China): Specializes in high-volume API synthesis for Asian markets[6].
• Delmar Chemicals (Canada): Provides API for North American and European markets, adhering to FDA and EMA standards[14].

These suppliers must comply with Good Manufacturing Practices (GMP) and undergo rigorous audits by Pfizer and regulatory agencies[6][14]. The diversification of API sources mitigates supply chain risks, particularly during geopolitical disruptions or increased demand.

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Distributors and Wholesalers

U.S. Distribution Network

In the U.S., Pfizer partners with major wholesalers like AmerisourceBergen and Cardinal Health to distribute Xeljanz to pharmacies and hospitals[4][12]. The Defined Distribution system, implemented in March 2022 and updated in May 2023, restricts 340B-covered entities to purchasing Xeljanz through registered contract pharmacies or wholly owned specialty pharmacies[4][12]. This policy aims to prevent duplicate discounts and diversion, aligning with the Third Circuit Court’s ruling in Sanofi Aventis U.S. LLC v. HHS[4].

International Distribution Agreements

Pfizer’s global distribution strategy involves regional partnerships. In Japan, Takeda Pharmaceutical Co. distributed Xeljanz until 2018, when Pfizer assumed sole responsibility following the termination of their co-promotion agreement[15]. Similarly, in Europe, Pfizer collaborates with Alliance Healthcare and Celesio AG to ensure timely delivery to pharmacies[2].

Specialty Pharmacies

Pfizer’s Defined Oncology Distribution Network (DON) includes specialty pharmacies like Oncology Supply and BioPlus Specialty Pharmacy, which handle Xeljanz shipments for 340B hospitals[12]. These entities are critical for maintaining access in underserved regions, particularly for rural healthcare providers.

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Retail and Online Pharmacies

Traditional Pharmacies

Xeljanz is available at major retail chains such as CVS Health, Walgreens, and Walmart Pharmacy, which procure the drug through authorized wholesalers[7][10][16]. These pharmacies leverage bulk purchasing agreements to offer competitive pricing, though costs remain high due to Pfizer’s patent protections.

Online Pharmacies

Online platforms have emerged as key suppliers, particularly for uninsured or cost-sensitive patients:

• Marley Drug: Offers Xeljanz XR at wholesale prices ($70 for a 12-month supply) through a direct-to-patient model[10].
• LifeRx Pharmacy: Provides domestic and international shipping, requiring a valid prescription and import permit for non-U.S. orders[16].
• Canadian Pharmacy King: Sells branded and generic Xeljanz at reduced prices, catering to North American patients[7].

These pharmacies source Xeljanz from licensed wholesalers or international suppliers, though regulatory scrutiny over importation practices persists[7][16].

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Regulatory and Market Challenges

FDA Safety Advisories and Restrictions

In 2021, the FDA issued a black box warning for Xeljanz due to increased risks of thrombosis, cancer, and cardiovascular events[3][13]. This led to dose restrictions for ulcerative colitis patients and heightened monitoring requirements for distributors[3]. Pfizer’s sales nonetheless grew by 9% in 2020, reflecting strong demand despite safety concerns[3].

340B Program Compliance

Pfizer’s 2023 Defined Distribution update requires 340B hospitals to designate contract pharmacies via the Office of Pharmacy Affairs Information System (OPAIS)[4][12]. Non-compliant entities risk losing access to 340B pricing, necessitating close coordination between hospitals and distributors like AmerisourceBergen[4].

Generic Competition and Future Outlook

With key patents expiring post-2025, companies like Hetero Drugs and Aurobindo Pharma are poised to launch generic tofacitinib, potentially disrupting Pfizer’s market dominance[6][14]. Pfizer’s response includes expanding indications (e.g., juvenile idiopathic arthritis) and investing in next-generation JAK inhibitors to retain market share[8].

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Conclusion

The supply chain for Xeljanz exemplifies the complexity of modern pharmaceutical distribution, combining in-house manufacturing, third-party API suppliers, and multi-tiered distribution networks. Pfizer’s strategic control over production and regulatory compliance ensures steady access, while partnerships with wholesalers and specialty pharmacies address diverse patient needs. However, emerging generic competitors and evolving 340B policies present challenges that will shape the drug’s future availability. Stakeholders must navigate these dynamics to maintain equitable access while safeguarding supply chain integrity.

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Highlight: “Pfizer’s Defined Distribution system represents a continued distribution preference provided to 340B covered entities, ensuring access while mitigating diversion risks”[4].

Key Takeaways

1. Pfizer Inc. remains the sole manufacturer of branded Xeljanz, with production facilities in the U.S., UK, and India.
2. Over 50 third-party API suppliers, including Hetero Drugs and Hunan Huateng, support global production.
3. Distributors like AmerisourceBergen and Cardinal Health facilitate U.S. delivery, while regional partners handle international markets.
4. Online pharmacies offer cost-saving alternatives but face regulatory hurdles.
5. FDA safety warnings and 340B policy updates necessitate adaptive supply chain strategies.

FAQs

1. Who manufactures Xeljanz?
   Pfizer Inc. produces all branded Xeljanz formulations[1][9].

2. Can 340B hospitals purchase Xeljanz through contract pharmacies?
   Yes, under Pfizer’s Defined Distribution system, federal grantees may use registered contract pharmacies[4][12].

3. Are generic versions of Xeljanz available?
   Generic tofacitinib is available in India and other markets with expired patents[6][14].

4. How does Pfizer ensure API quality?
   Third-party suppliers must comply with GMP standards and undergo Pfizer audits[6][14].

5. What are the risks of purchasing Xeljanz online?
   Patients should verify pharmacy licensure and prescription requirements to avoid counterfeit products[7][16].

References

1. https://www.drugs.com/medical-answers/makes-xeljanz-made-3560552/
2. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-xeljanzr-tofacitinib-receives-marketing
3. https://www.fiercepharma.com/marketing/fda-weighs-harsher-sanctions-against-pfizer-s-xeljanz-heels-trial-raised-safety-red-flags
4. https://www.amerisourcebergen.com/-/media/assets/amerisourcebergen/340b/manf-letters/pfizer-340b-announcement----effective-may-1-2023.pdf
5. https://www.indiamart.com/proddetail/xeljanz-xr-tofacitinib-2851291020173.html
6. https://www.pharmacompass.com/manufacturers-suppliers-exporters/xeljanz-xr
7. https://www.canadianpharmacyking.com/Drug/Xeljanz
8. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-xeljanzr-tofacitinib-treatment
9. https://www.shouselaw.com/torts/xeljanz/manufacturer/
10. https://www.marleydrug.com/drug-xeljanz-xr-tofacitinib
11. https://specialitypharma.com/rheumatoid-arthritis/buy-xeljanz-tofacitinib-citrate-brands.html
12. https://www.alinea-group.com/wp-content/uploads/2022/07/Pfizer_Contract_Pharmacy_Policy_Update_4.15.2022.pdf
13. https://www.drugwatch.com/xeljanz/
14. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/xeljanz
15. https://www.takeda.com/newsroom/newsreleases/2017/termination-of-co-promotion-and-takedas-distribution-of-xeljanz-tablets-5-mg-in-japan/
16. https://www.liferxpharmacy.com/products/xeljanz.html