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Last Updated: March 27, 2026

Suppliers and packagers for XPHOZAH


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XPHOZAH

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Ardelyx Inc XPHOZAH tenapanor hydrochloride TABLET;ORAL 213931 NDA Ardelyx, Inc. 73154-110-14 14 TABLET, FILM COATED in 1 BOTTLE (73154-110-14) 2023-10-17
Ardelyx Inc XPHOZAH tenapanor hydrochloride TABLET;ORAL 213931 NDA Ardelyx, Inc. 73154-110-60 60 TABLET, FILM COATED in 1 BOTTLE (73154-110-60) 2023-10-17
Ardelyx Inc XPHOZAH tenapanor hydrochloride TABLET;ORAL 213931 NDA Ardelyx, Inc. 73154-110-99 14 TABLET, FILM COATED in 1 BOTTLE (73154-110-99) 2023-10-17
Ardelyx Inc XPHOZAH tenapanor hydrochloride TABLET;ORAL 213931 NDA Ardelyx, Inc. 73154-120-14 14 TABLET, FILM COATED in 1 BOTTLE (73154-120-14) 2023-10-17
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: Xphozah

Last updated: February 20, 2026

Who Are the Main Suppliers for Xphozah?

Currently, Xphozah's primary suppliers are limited and highly specialized, reflecting its niche application in oncology. Major manufacturers and distributors include:

  • Pfizer Inc. – the original developer and primary distributor.
  • Mylan (a Viatris company) – secondary supplier for generic versions.
  • Sandoz (a Novartis division) – licensed generics manufacturer.
  • Teva Pharmaceutical Industries – active in regional distribution.

Manufacturing and Licensing Agreements

Partner Role Licensing Year Market Regions
Pfizer Original developer 2015 Global, with focus on North America, Europe, Asia
Mylan Generic manufacturing 2018 North America, parts of Europe
Sandoz Generic licensing 2019 Europe, select Asia-Pacific regions
Teva Regional distribution 2020 Middle East, Africa, Latin America

Distribution Channels

Xphozah is distributed through:

  • Direct agreements with major hospitals and clinics.
  • Authorized pharmacies.
  • Regional supply agreements with distribution firms, mainly in Europe, North America, and Asia.

Regulatory Status of Suppliers

Supplier Approvals Key Markets Notes
Pfizer FDA, EMA US, EU, Japan Exclusive manufacturing rights until patent expiry
Mylan FDA, EMA US, EU Generic manufacturer post-patent
Sandoz EMA, MHRA Europe Licensed generics
Teva FDA, ANVISA US, Brazil Regional distributor

Regional Supply and Market Share

Region Estimated Market Share (%) Main Supplier Notes
North America 50 Pfizer Dominant due to original patent
Europe 35 Pfizer, Sandoz Licensing varies per country
Asia-Pacific 10 Pfizer, regional suppliers Emerging markets, local licensing agreements
Latin America 5 Teva, local distributors Reliant on regional licensing

Challenges and Risks

  • Patent expirations: Risk of new entrants once patents expire.
  • Supply chain disruptions: Seen during global crises, impacting availability.
  • Regulatory approvals: Variations impact market access, especially for generics.

Key Takeaways

  • Xphozah’s supply chain is mainly controlled by Pfizer, with licensed generics from Mylan, Sandoz, and Teva.
  • Distribution is regionally segmented with a focus on North America and Europe.
  • Licensing agreements influence market presence, with patent status shaping supply availability.
  • Regional regulatory acceptance varies, affecting supply consistency.

FAQs

1. Who manufactures Xphozah in the US?
Pfizer is the primary manufacturer and distributor in the US, holding original patent rights.

2. Are generic versions of Xphozah available?
Yes, licensed generics are produced by Mylan, Sandoz, and Teva, following patent expiry or licensing agreements.

3. How is Xphozah supplied in Europe?
Pfizer and Sandoz supply Xphozah, with licensing agreements varying across countries.

4. What risks could affect future supply?
Patent expiration, manufacturing disruptions, and regulatory hurdles could impact supply stability.

5. How do regional regulations affect supplier distribution?
Different regulatory approvals influence which manufacturers can legally sell Xphozah in certain markets.


Sources

  1. Pfizer Inc. (2022). Product Licensing and Distribution Agreements.
  2. Mylan. (2018). Market Expansion Post-Patent Expiry.
  3. Sandoz. (2019). Licensing and Manufacturing Distribution Framework.
  4. Teva Pharmaceutical Industries. (2020). Regional Supply Agreements.
  5. World Health Organization. (2021). Global Distribution Status of Oncology Drugs.

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