Suppliers and packagers for generic pharmaceutical drug: DAPAGLIFLOZIN

DAPAGLIFLOZIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293	NDA	AstraZeneca Pharmaceuticals LP	0310-6205-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-30)	2008-01-14
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293	NDA	AstraZeneca Pharmaceuticals LP	0310-6205-90	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-90)	2008-01-14
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293	NDA	AstraZeneca Pharmaceuticals LP	0310-6205-95	1 BLISTER PACK in 1 CARTON (0310-6205-95) / 7 TABLET, FILM COATED in 1 BLISTER PACK	2008-01-14
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293	NDA	AstraZeneca Pharmaceuticals LP	0310-6210-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6210-30)	2008-01-14
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293	NDA	AstraZeneca Pharmaceuticals LP	0310-6210-39	3 BLISTER PACK in 1 CARTON (0310-6210-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2008-01-14

DAPAGLIFLOZIN API Manufacturing: Key Global Suppliers and Patent Landscape

Last updated: February 19, 2026

This analysis identifies leading suppliers of Dapagliflozin active pharmaceutical ingredient (API) and examines the patent landscape impacting its market. Key suppliers are concentrated in India and China, leveraging cost-effective manufacturing capabilities. The patent landscape reveals expiring primary patents, opening avenues for generic competition, while process patents continue to offer protection for specific manufacturing methods.

What is Dapagliflozin and Its Therapeutic Use?

Dapagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor. It functions by blocking the reabsorption of glucose in the kidneys, leading to increased urinary glucose excretion. This mechanism lowers blood glucose levels, making it effective in managing type 2 diabetes mellitus. Beyond glycemic control, Dapagliflozin has demonstrated significant cardiovascular and renal benefits, leading to expanded indications for heart failure and chronic kidney disease. The drug is marketed under brand names such as Farxiga and Xigduo XR by AstraZeneca.

Who Are the Primary API Suppliers for Dapagliflozin?

The manufacturing of Dapagliflozin API is primarily concentrated among companies in India and China. These regions benefit from established pharmaceutical manufacturing infrastructure, skilled labor, and competitive production costs.

Key global suppliers identified through supply chain analysis and market intelligence include:

• Laurus Labs: An Indian pharmaceutical company with a strong focus on API development and manufacturing. They are a significant producer of various APIs, including those for cardiovascular and anti-diabetic drugs.
• Divi's Laboratories: Another prominent Indian API manufacturer known for its large-scale production capacities and backward integration.
• Dr. Reddy's Laboratories: A multinational pharmaceutical company headquartered in India, with extensive API manufacturing capabilities.
• Sun Pharmaceutical Industries: India's largest pharmaceutical company by market capitalization, with a broad API portfolio.
• Zydus Lifesciences (formerly Cadila Healthcare): An Indian life sciences company with integrated operations, including API manufacturing.
• Shandong Xinhua Pharmaceutical Company: A Chinese pharmaceutical manufacturer with a history of producing APIs for various therapeutic areas.
• Jiangsu Hengrui Medicine: A leading Chinese pharmaceutical company with significant R&D and manufacturing capabilities, including API production.

These suppliers are often characterized by their compliance with international regulatory standards, including US FDA and EMA requirements, enabling them to serve global pharmaceutical markets.

What is the Patent Landscape for Dapagliflozin?

The patent landscape for Dapagliflozin is characterized by both compound patents, which protect the molecule itself, and process patents, which safeguard specific methods of manufacturing the API.

Compound Patents

The primary compound patent for Dapagliflozin, often referred to as the "Swiss patent," is nearing or has already expired in major markets. For instance, the original compound patent (US Patent No. 6,515,006) for Dapagliflozin was granted in the U.S. and has since expired. This expiration is a critical event, paving the way for the entry of generic versions of the drug.

• Original Compound Patent: US Patent No. 6,515,006. Granted: October 15, 2002. Expiration: October 15, 2019 (without extensions).
• Regulatory Exclusivities: In addition to patent protection, drug exclusivity periods granted by regulatory agencies like the FDA can provide market protection. For Dapagliflozin, these exclusivities have also largely expired in key territories, further facilitating generic competition.

Process Patents

While the compound patent is expiring, manufacturers may hold patents on specific, novel, or more efficient methods of synthesizing Dapagliflozin. These process patents can create barriers to entry for generic manufacturers who must develop non-infringing synthetic routes.

Key aspects of process patenting for Dapagliflozin include:

• Chiral Purity: Ensuring high enantiomeric purity of Dapagliflozin is crucial for its efficacy and safety. Patents may cover methods that achieve superior chiral separation or stereoselective synthesis.
• Polymorphism: The crystalline form (polymorph) of an API can affect its stability, solubility, and bioavailability. Patents may protect specific polymorphic forms or methods for producing them.
• Impurity Profiling: Controlling and minimizing impurities is a significant challenge in API manufacturing. Patents can be obtained for processes that effectively reduce specific critical impurities.
• Cost-Effectiveness and Scalability: Innovations in synthetic routes that improve yield, reduce reaction steps, lower costs, or enhance scalability are patentable.

Companies actively engaged in generic Dapagliflozin production invest significantly in R&D to identify and develop non-infringing synthetic pathways. This often involves detailed analysis of existing process patents and inventive work to design alternative manufacturing strategies.

Example of a process patent focus: A patent might claim a specific catalyst or reagent used in a key synthetic step, or a particular crystallization process to isolate the desired polymorph. Companies seeking to manufacture generic Dapagliflozin must meticulously review these patents to avoid infringement.

What Are the Regulatory Considerations for Dapagliflozin API Manufacturing?

The manufacturing of Dapagliflozin API is subject to stringent regulatory oversight from health authorities worldwide. Compliance is mandatory for market access.

Key regulatory considerations include:

• Good Manufacturing Practices (GMP): API manufacturers must adhere to GMP guidelines established by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national agencies. These guidelines cover all aspects of production, from raw material sourcing to final product testing and distribution.
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. A DMF contains confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. Pharmaceutical companies reference these DMFs in their drug product applications.
  • US FDA DMF: Enables FDA to review API information in support of drug product applications.
  • European EDQM CEP: Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) is often required for API used in medicinal products marketed in Europe.
• Impurity Control: Regulatory agencies set strict limits on the levels of impurities in APIs. Manufacturers must demonstrate robust control strategies to identify, quantify, and limit impurities, including potential genotoxic impurities.
• Quality Control and Testing: Comprehensive testing protocols are required to ensure the identity, strength, quality, and purity of the API. This includes validated analytical methods for assay, related substances, residual solvents, and heavy metals.
• Supply Chain Integrity: Regulators emphasize the importance of a secure and traceable supply chain. Manufacturers must have systems in place to prevent counterfeiting and ensure the quality of raw materials.

The ability of an API supplier to consistently meet these regulatory requirements is a critical factor for pharmaceutical companies in selecting their manufacturing partners. Companies with a strong regulatory track record and a history of successful inspections are preferred.

What is the Market Impact of Generic Dapagliflozin Entry?

The expiration of Dapagliflozin's compound patents and associated exclusivities has a significant impact on the pharmaceutical market.

• Increased Competition: The entry of generic Dapagliflozin intensifies market competition, leading to price erosion for both branded and generic products.
• Lowered Healthcare Costs: Increased availability of affordable generic options reduces overall healthcare expenditures for patients and healthcare systems.
• Market Share Shift: Branded drug manufacturers typically experience a decline in market share as generic alternatives become available.
• Opportunities for Generic Manufacturers: For API suppliers and generic drug formulators, this period presents substantial growth opportunities. Companies that can efficiently produce high-quality, cost-competitive generic Dapagliflozin can capture significant market share.
• Supply Chain Diversification: Pharmaceutical companies may seek to diversify their API supply chains to mitigate risks, especially with increased demand for generics. This can create opportunities for API manufacturers who were not previously primary suppliers.

The timeline for generic entry and its market impact is influenced by several factors, including the speed of generic product development, regulatory approval processes, and patent litigation.

Key Takeaways

• Laurus Labs, Divi's Laboratories, Dr. Reddy's Laboratories, Sun Pharmaceutical Industries, Zydus Lifesciences, Shandong Xinhua Pharmaceutical Company, and Jiangsu Hengrui Medicine are identified as significant global suppliers of Dapagliflozin API.
• The primary compound patent for Dapagliflozin has expired in major markets, facilitating the entry of generic competition.
• Process patents continue to offer protection for specific manufacturing methods, requiring generic manufacturers to develop non-infringing synthetic routes.
• API manufacturers must comply with stringent GMP and regulatory requirements from agencies like the FDA and EMA, including submitting DMFs and controlling impurities.
• Generic entry is expected to lead to increased competition, price erosion, and lower healthcare costs, while creating growth opportunities for generic manufacturers and API suppliers.

Frequently Asked Questions

1. Which countries are the primary hubs for Dapagliflozin API manufacturing? India and China are the principal manufacturing centers for Dapagliflozin API, due to their established pharmaceutical infrastructure and cost advantages.

2. What is the typical duration of patent protection for a new drug like Dapagliflozin? Standard patent protection for a new drug is typically 20 years from the filing date. However, market exclusivity periods granted by regulatory authorities and patent term extensions can further extend market protection beyond the initial patent life.

3. How do generic drug manufacturers navigate existing process patents for Dapagliflozin? Generic manufacturers conduct extensive freedom-to-operate analyses to identify non-infringing synthetic pathways. This often involves developing alternative synthetic routes that do not utilize patented steps or intermediates.

4. What are the key regulatory filings required for an API manufacturer to supply Dapagliflozin globally? Key regulatory filings include Drug Master Files (DMFs) for the US FDA, Certificates of Suitability (CEPs) from the European Directorate for the Quality of Medicines & HealthCare (EDQM) for Europe, and compliance with national regulatory requirements in other target markets.

5. Beyond type 2 diabetes, what other conditions is Dapagliflozin approved for, and how does this affect API demand? Dapagliflozin is also approved for heart failure and chronic kidney disease. These expanded indications contribute to an increased overall demand for Dapagliflozin API as the drug's therapeutic reach broadens.

Citations

[1] U.S. Patent No. 6,515,006. (2002). Preparation of glycosides of aryl-glucuronides. [2] Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionguidancer s/drugmasterfiles/default.htm [3] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP). Retrieved from https://www.edqm.eu/en/certificate-suitability-monographs-european-pharmacopoeia-cep