ASTAGRAF XL Drug Patent Profile

When do Astagraf Xl patents expire, and when can generic versions of Astagraf Xl launch?

Astagraf Xl is a drug marketed by Astellas and is included in one NDA.

The generic ingredient in ASTAGRAF XL is tacrolimus. There are twenty drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Astagraf Xl

A generic version of ASTAGRAF XL was approved as tacrolimus by SANDOZ on August 10^th, 2009.

Summary for ASTAGRAF XL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	10
Drug Prices:	Drug price information for ASTAGRAF XL
What excipients (inactive ingredients) are in ASTAGRAF XL?	ASTAGRAF XL excipients list
DailyMed Link:	ASTAGRAF XL at DailyMed

See drug prices for ASTAGRAF XL

Recent Clinical Trials for ASTAGRAF XL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Shahid Beheshti University of Medical Sciences	NA
University of Colorado, Denver	Early Phase 1
Cedars-Sinai Medical Center	Phase 4

See all ASTAGRAF XL clinical trials

Pharmacology for ASTAGRAF XL

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors

Paragraph IV (Patent) Challenges for ASTAGRAF XL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ASTAGRAF XL	Extended-release Capsules	tacrolimus	0.5 mg, 1 mg, and 5 mg	204096	1	2013-09-24

US Patents and Regulatory Information for ASTAGRAF XL

ASTAGRAF XL is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-001	Jul 19, 2013	AB	RX	Yes	No
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013	AB	RX	Yes	No
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	AB	RX	Yes	Yes

Expired US Patents for ASTAGRAF XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013	8,551,522
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	8,551,522
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	6,576,259

EU/EMA Drug Approvals for ASTAGRAF XL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Astellas Pharma Europe B.V.	Modigraf	tacrolimus	EMEA/H/C/000954Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.	Authorised	no	no	no	2009-05-15
Astellas Pharma Europe BV	Advagraf	tacrolimus	EMEA/H/C/000712Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.	Authorised	no	no	no	2007-04-23
Chiesi Farmaceutici S.p.A.	Envarsus	tacrolimus	EMEA/H/C/002655Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.	Authorised	no	no	no	2014-07-18

International Patents for ASTAGRAF XL

See the table below for patents covering ASTAGRAF XL around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	I235068
South Korea	100440553
Poland	343096

Market Dynamics and Financial Trajectory for Astagraf XL

Last updated: July 27, 2025

Introduction

Astagraf XL (generic name: tacrolimus extended-release) is an immunosuppressant drug primarily prescribed to prevent organ rejection in kidney, liver, and heart transplants. Developed by Astellas Pharma, it is a prolonged-release formulation of tacrolimus, designed to optimize pharmacokinetics and improve patient adherence compared to immediate-release formulations. As the pharmaceutical landscape evolves with innovations and regulatory shifts, understanding Astagraf XL’s market dynamics and financial trajectory becomes essential for stakeholders across the healthcare spectrum.

Market Landscape Overview

Current Market Position

Astagraf XL is positioned within the niche of immunosuppressants, which are classified among high-value specialty drugs. The global immunosuppressant market is projected to reach USD 4.5 billion by 2028, with tacrolimus-based therapies constituting a significant share[1]. Its primary competitors include Prograf (Pfizer), generics of tacrolimus, and newer agents like belatacept, which is used in certain transplant cases.

Market Segments

• Organ Transplantation: The dominant application, accounting for over 85% of its sales, with demand driven by transplant patient volumes.
• Reimbursement and Access: Variability exists across countries; high-cost drugs such as Astagraf XL often face reimbursement hurdles, impacting sales trajectories.
• Note: Growth of biosimilar tacrolimus products and their pricing pressures influence Astagraf XL's market share.

Geographical Dynamics

• North America: Largest market—driven by high transplantation rates, supportive healthcare infrastructure, and favorable reimbursement policies.
• Europe: Significant adoption, though more conservative due to regulatory delays and reimbursement challenges.
• Asia-Pacific: Rapidly expanding, with increasing transplantation procedures and economic growth supporting market opportunities, despite price sensitivity and regulatory hurdles.

Regulatory and Patent Landscape

Patent Status and Exclusivity

Astellas holds key patent rights protecting Astagraf XL until approximately 2025 in many jurisdictions, with patent expirations prompting a surge in generic competition[2]. Such patent cliffs typically precipitate revenue declines unless offset by market penetration or new indications.

Regulatory Approvals and Pharmacovigilance

The drug’s approval in major markets has been stable, but safety concerns related to nephrotoxicity and neurotoxicity necessitate ongoing pharmacovigilance, impacting prescribing patterns and market confidence.

Market Drivers

Increasing Transplant Procedures

Global transplantation numbers continue to rise, reaching over 150,000 procedures annually, driven by aging populations and improved surgical techniques. The expansion of indication beyond traditional transplants, such as in autoimmune diseases, could unlock additional markets.

Patient Compliance and Extended-Release Formulation

Astagraf XL’s once-daily dosing improves adherence, a critical factor influencing transplant success rates and long-term graft survival. This advantage sustains demand among clinicians prioritizing patient compliance.

Advances in Immunosuppressive Regimens

Emergence of adjunct therapies and personalized medicine approach may influence the utilization of Astagraf XL, potentially enabling combination therapies that enhance efficacy and reduce adverse effects.

Pricing and Reimbursement Policies

Reimbursement frameworks significantly influence market expansion. Countries adopting value-based care models may favor innovative formulations like Astagraf XL if they demonstrate cost-effectiveness through improved outcomes.

Market Challenges

Generic Competition and Price Erosion

Patent expirations open pathways for generics, which exert downward pressure on pricing and profit margins. Price erosion often results in volume-driven revenue declines unless market share is preserved.

Safety and Tolerability Concerns

Adverse effects continue to influence prescribing behaviors. The potential for nephrotoxicity and other toxicities necessitates careful patient management, possibly limiting broad adoption.

Regulatory Delays and Divergent Approvals

Divergent regulatory requirements across regions can delay approvals of new formulations or indications, restricting global growth.

Financial Trajectory

Revenue Streams

• Peak Revenue Estimates: Prior to patent expiry, Astagraf XL generated annual revenues estimated at USD 500-700 million globally, with North America contributing approximately 60%[3].
• Post-Patent Period: Anticipated decline of 20-30% yearly without new indications or formulations, aligned with typical patent cliffs in this class.

Growth Opportunities

• New Indications: Exploration in autoimmune diseases or other immune-mediated conditions could sustain revenue streams.
• Formulation Innovations: Extended-release or combination formulations may command premium pricing.
• Market Expansion: Focused efforts in emerging markets could augment sales, contingent on regulatory approvals and pricing strategies.

Profitability Analysis

Profit margins will likely compress post-patent expiry due to generic competition. Nevertheless, optimized manufacturing and supply chain efficiencies, along with portfolio diversification, can buffer margin erosion.

Strategic Outlook

Astellas’s strategic focus on lifecycle management—launching new formulations, acquiring complementary assets, and expanding into emerging markets—will significantly influence Astagraf XL’s long-term financial trajectory.

Conclusion

The market dynamics for Astagraf XL are characterized by a mature, high-value niche with predictable growth influenced by transplantation procedures, adherence benefits, and regulatory factors. Short- to mid-term revenues are likely to plateau or decline due to patent expiration and generic competition, unless offset by new indications, formulations, or market expansions. Long-term prospects depend on strategic innovation, regulatory navigation, and healthcare industry shifts toward personalized, value-based care.

---

Key Takeaways

• Patent expiration around 2025 will significantly impact revenues, necessitating proactive lifecycle management.
• Growing transplantation rates globally serve as a primary market driver, with expansion into autoimmune indications presenting opportunities.
• Generic competition exerts downward pricing pressure, underscoring the importance of differentiating formulations and indications.
• Regulatory and reimbursement policies will shape market access, especially in emerging markets with increasing healthcare investments.
• Innovation in formulations and combination therapies remains critical for sustaining growth and financial stability.

---

FAQs

1. How will patent expiry affect Astagraf XL’s market share?
Patent expiry around 2025 will open the market to generic tacrolimus products, likely leading to a significant decline in Astagraf XL’s market share and revenues unless supported by new indications or formulations.

2. What are key competitive advantages of Astagraf XL over immediate-release tacrolimus?
Its once-daily extended-release formulation improves patient adherence, potentially enhancing transplant outcomes and offering a competitive edge in the immunosuppressant landscape.

3. Are there emerging markets where Astagraf XL can expand?
Yes, regions like Asia-Pacific exhibit rapid increases in transplant procedures and healthcare expenditure, presenting significant growth prospects contingent on regulatory approvals and pricing strategies.

4. What strategies can Astellas employ to sustain revenues post-patent expiry?
Launching new formulations, exploring additional indications, expanding into emerging markets, and engaging in lifecycle management initiatives are vital strategies.

5. How do safety concerns influence Astagraf XL’s market dynamics?
Ongoing concerns over nephrotoxicity and neurotoxicity may restrict prescribing to specific patient populations and influence clinicians to consider alternative therapies or formulations with better safety profiles.

---

Sources

[1] Research and Markets. "Global Immunosuppressants Market Forecast 2028."
[2] Astellas Pharma. "Patent Portfolio and Lifecycle Analysis."
[3] Evaluate Pharma. "Astagraf XL Market Data and Financials."