Suppliers and packagers for generic pharmaceutical drug: AZILSARTAN KAMEDOXOMIL

AZILSARTAN KAMEDOXOMIL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lupin	AZILSARTAN MEDOXOMIL	azilsartan kamedoxomil	TABLET;ORAL	214489	ANDA	Lupin Pharmaceuticals, Inc.	70748-236-06	30 TABLET in 1 BOTTLE (70748-236-06)	2026-05-14
Lupin	AZILSARTAN MEDOXOMIL	azilsartan kamedoxomil	TABLET;ORAL	214489	ANDA	Lupin Pharmaceuticals, Inc.	70748-237-06	30 TABLET in 1 BOTTLE (70748-237-06)	2026-05-14
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796	NDA	Wilshire Pharmaceuticals, Inc.	52536-004-03	30 TABLET in 1 BOTTLE (52536-004-03)	2026-04-27
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796	NDA	Wilshire Pharmaceuticals, Inc.	52536-008-03	30 TABLET in 1 BOTTLE (52536-008-03)	2026-04-27
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796	NDA	Azurity Pharmaceuticals, Inc.	60631-040-30	30 TABLET in 1 BOTTLE (60631-040-30)	2013-02-01
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796	NDA	Azurity Pharmaceuticals, Inc.	60631-040-77	7 TABLET in 1 BOTTLE (60631-040-77)	2013-02-01

Suppliers for AZILSARTAN KAMEDOXOMIL

Last updated: April 9, 2026

Azilsartan Kamedoxomil is a combination antihypertensive agent composed of azilsartan, an angiotensin II receptor blocker (ARB), and kamedoxomil, a prodrug metabolized into an active metabolite. It is marketed under various brand names globally.

Major Manufacturers and Suppliers

1. Takeda Pharmaceuticals

• Product Name: Edarbi (azilsartan medoxomil monotherapy), AZILSARTAN KAMEDOXOMIL (combination)
• Headquarters: Japan
• Supply Highlights: Takeda is the primary global supplier of azilsartan-based medications, including combination formulations with kamedoxomil. It holds key patents and licenses for these drugs in several markets.

2. Farmindustria (Italy) and Other Generics Suppliers

• Manufacturers: Multiple regional generics producers worldwide.
• Supply Highlights: Several local companies produce generic versions of azilsartan and combination drugs with kamedoxomil. These companies typically obtain licensing arrangements or utilize patent expirations.

3. Teva Pharmaceuticals

• Product: Generic azilsartan medoxomil; potential combination formulations
• Supply Highlights: While primarily offering generic azilsartan, Teva may provide combination drugs depending on regional regulatory approvals.

4. Other Regional Suppliers

• Various companies in regions like India, China, and South Korea manufacture generic versions, including:
  • Zhejiang Huahai Pharmaceutical (China)
  • Hetero Labs (India)
  • Aurobindo Pharma (India)
• These companies often supply APIs and finished dosage forms to global markets, contingent on regulatory compliance.

Supply Chain Dynamics and Licensing Agreements

• Patent Status: In many territories, azilsartan Kamedoxomil is protected by patents held by Takeda, restricting generic entry until patent expiration. Patent expiry generally occurred around 2028 in major markets.
• Regulatory Approvals: Suppliers secure approvals from agencies such as the FDA (U.S.), EMA (Europe), and others to market generic or branded versions.

API and Finished Dose Production

• Active Pharmaceutical Ingredient (API): Suppliers like Zhejiang Huahai, Hetero Labs, and Aurobindo produce APIs for both azilsartan and kamedoxomil.
• Finished Dosage Forms: Typically manufactured by contract manufacturing organizations (CMOs) under licensing agreements or via Takeda's in-house facilities for branded products.

Distribution and Market Penetration

• Breaking down regional supply:
  • United States: Takeda (branded), multiple generics
  • Europe: Takeda, regional generics
  • Asia: Significant presence of regional suppliers, especially India and China
  • Emerging Markets: Growing access via regional generics and imports

Summary of Key Suppliers

Supplier	Product Focus	Region	Licensing/Patents	Notes
Takeda	Branded & Generics	Global	Has patents until ~2028	Primary innovator and patent holder
Hetero Labs	APIs and generics	India	Patent expired or license-dependent	Major regional generic supplier
Zhejiang Huahai	APIs	China	Active in the market	Supplies APIs for multiple markets
Aurobindo Pharma	APIs & Generics	India	Regional patents/license agreements	Supplies APIs and finished formulations

Regulatory Considerations

• Biosimilar and Generic Entry: Patents limit generic manufacturing until expiry; approval depends on clinical equivalence.
• Quality Standards: Suppliers must adhere to regulatory standards like WHO GMP, FDA, and EMA certifications.

Key Takeaways

• Takeda dominates global supply with its branded product Edarbi, holding patents until approximately 2028.
• Multiple regional suppliers produce APIs and generics, especially in India and China.
• Licensing agreements and patent protections are critical in determining market access.
• The global supply chain includes both branded manufacturer Takeda and various regional generic producers.
• Regulatory approval, patent status, and regional policies influence supply availability.

FAQs

1. Who are the main suppliers of azilsartan Kamedoxomil?
   Takeda Pharmaceuticals is the primary global supplier; regional generics include Aurobindo and Hetero Labs.

2. When will patent restrictions for azilsartan Kamedoxomil expire?
   Approximate patent expiration in major markets occurs around 2028, enabling potential generic entry.

3. Which regions have the most generic suppliers?
   India and China have the highest number of API producers and generic manufacturers for azilsartan-based drugs.

4. Are there licensed generics available?
   Yes, generics are available via licensing agreements or once patents expire, subject to regional approval.

5. What role do APIs play in the supply chain?
   APIs are produced primarily in China and India, then formulated into finished dosage forms in various regions depending on market access.

References

[1] U.S. Food and Drug Administration. (2021). Approved Drugs: Edarbi (azilsartan medoxomil).
[2] European Medicines Agency. (2022). Summary of Product Characteristics for Edarbi.
[3] Patent data for azilsartan in the U.S. and EU (2022).
[4] Leading Indian pharmaceutical companies' annual reports, 2022.
[5] Market supply chain insights from IQVIA, 2022.