PROGRAF Drug Patent Profile

Which patents cover Prograf, and what generic alternatives are available?

Prograf is a drug marketed by Astellas and is included in three NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prograf

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

Summary for PROGRAF

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	403
Drug Prices:	Drug price information for PROGRAF
What excipients (inactive ingredients) are in PROGRAF?	PROGRAF excipients list
DailyMed Link:	PROGRAF at DailyMed

See drug prices for PROGRAF

See drug sales revenues for PROGRAF

Recent Clinical Trials for PROGRAF

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

Sponsor	Phase
University Hospital, Essen	Phase 3
University Health Network, Toronto	Phase 4
NYU Langone Health	Phase 2

See all PROGRAF clinical trials

Pharmacology for PROGRAF

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors

US Patents and Regulatory Information for PROGRAF

PROGRAF is protected by zero US patents and three FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	PROGRAF	tacrolimus	CAPSULE;ORAL	050708-003	Aug 24, 1998	AB	RX	Yes	No
Astellas	PROGRAF	tacrolimus	FOR SUSPENSION;ORAL	210115-001	May 24, 2018		RX	Yes	No
Astellas	PROGRAF	tacrolimus	CAPSULE;ORAL	050708-001	Apr 8, 1994	AB	RX	Yes	No
Astellas	PROGRAF	tacrolimus	INJECTABLE;INJECTION	050709-001	Apr 8, 1994		RX	Yes	Yes
Astellas	PROGRAF	tacrolimus	FOR SUSPENSION;ORAL	210115-001	May 24, 2018		RX	Yes	No
Astellas	PROGRAF	tacrolimus	CAPSULE;ORAL	050708-003	Aug 24, 1998	AB	RX	Yes	No

Expired US Patents for PROGRAF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	PROGRAF	tacrolimus	INJECTABLE;INJECTION	050709-001	Apr 8, 1994	5,260,301

EU/EMA Drug Approvals for PROGRAF

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Astellas Pharma Europe B.V.	Modigraf	tacrolimus	EMEA/H/C/000954 Prophylaxis 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/000712 Prophylaxis 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/002655 Prophylaxis 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
LEO Pharma A/S	Protopic	tacrolimus	EMEA/H/C/000374 Flare treatmentAdults and adolescents (16 years of age and above)Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.Children (two years of age and above)Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.Maintenance treatmentMaintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).	Authorised	no	no	no	2002-02-27
Teva B.V.	Tacforius	tacrolimus	EMEA/H/C/004435 Prophylaxis 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	yes	no	no	2017-12-08
Astellas Pharma GmbH	Protopy	tacrolimus	EMEA/H/C/000375 Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).	Withdrawn	no	no	no	2002-02-28

International Patents for PROGRAF

See the table below for patents covering PROGRAF around the world.

Country	Patent Number	Title	Estimated Expiration
Greece	3021777
Spain	2093650
Canada	2037408	SOLUTION MACROLIDE PHARMACEUTIQUE NON-AQUEUSE (A NONAQUEOUS PHARMACEUTICAL MACROLIDE SOLUTION)
Ireland	75221	A pharmaceutical solution comprising derivatives of FK506
Mexico	9203032	UNA SOLUCION FARMACEUTICA.
Hungary	211502

PROGRAF Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tacrolimus (PROGRAF)

Introduction

Tacrolimus, marketed under the brand name PROGRAF, is a crucial immunosuppressant drug used primarily to prevent the rejection of transplanted organs. The market for tacrolimus is experiencing significant growth driven by several key factors.

Market Size and Growth

The global tacrolimus market has shown robust growth in recent years. As of 2023, the market size was valued at approximately $6.6 billion and is expected to grow to $8.47 billion by 2028, with a compound annual growth rate (CAGR) of 6.5%[1][5].

Key Drivers of Market Growth

Several factors are driving the growth of the tacrolimus market:

Increasing Organ Transplant Procedures

The rising number of organ transplant procedures, driven by factors such as end-stage organ failure, increased awareness about organ donation, and advancements in procedural technology, is a significant driver. For instance, the U.S. recorded 42,887 organ transplant procedures in 2022, highlighting the growing demand for immunosuppressants like tacrolimus[5].

Prevalence of Autoimmune Diseases

The increasing prevalence of autoimmune diseases, such as psoriasis and atopic dermatitis, has expanded the therapeutic applications of tacrolimus beyond organ transplantation. This broader application base contributes to the market's growth[1][5].

Regulatory Approvals and Research Investments

Regulatory approvals for new indications and increased investments in research and development are crucial for the market's expansion. Companies like Astellas Pharma have seen a 12.2% increase in R&D expenses, which is expected to positively impact the market[4].

Advancements in Drug Delivery Technologies

Improvements in drug delivery systems, such as novel formulations and pharmacogenomics for optimized dosing regimens, are enhancing the efficacy and safety of tacrolimus, further driving its adoption[1].

Financial Trajectory

Revenue and Profit Margins

Astellas Pharma Inc., the manufacturer of PROGRAF, reported significant revenue from the drug. In the fiscal year 2022, the sales of PROGRAF contributed substantially to Astellas' overall revenue, with the company aiming to achieve a core operating profit margin of over 30% by FY2025[2].

Regional Performance

The tacrolimus market is geographically diverse, with North America being a major contributor, accounting for $2.7 billion in revenue in 2023. The Asia Pacific region is also expected to grow rapidly due to increasing awareness of organ donations and rising demand in countries like China, India, and Japan[5].

Competitive Landscape

The tacrolimus market is highly competitive, with several global and local players. Key companies such as Astellas Pharma Inc., Abbott Laboratories, Novartis AG, Biocon Ltd., and Glenmark Pharmaceuticals Ltd. are actively involved in strategic developments like new product launches, acquisitions, and partnerships to strengthen their market positions[5].

Product Segmentation

The market is segmented based on product type, application, and end-use:

Product Type

The market includes various formulations such as injections, tablets and capsules, ointments, and granules. The injections segment is expected to reach $4.1 billion by 2032[5].

Application

Tacrolimus is used in immunosuppression, dermatitis, and other applications. The immunosuppression segment is poised to cross $6.4 billion by 2032[5].

End-Use

The hospital segment dominated the market with around $3.3 billion in revenue in 2023, followed by specialty clinics and other end-use segments[5].

Challenges and Pitfalls

Despite the growth, the tacrolimus market faces several challenges:

Adverse Effects

Severe side effects such as decreased urine output, burning or discomfort during urination, and other systemic issues can impact the market growth negatively. Alternative treatments, like prednisone, may also reduce the demand for tacrolimus in certain cases[4].

Local Competition

The presence of numerous local players, especially in regions like India, increases the competitive environment. Companies like Panacea Biotec with their product PanGraf have maintained a strong presence in the Indian market[4].

Future Outlook

The future of the tacrolimus market looks promising with several trends expected to shape its growth:

Personalized Medicine Approaches

The increasing adoption of personalized medicine approaches and advancements in drug delivery systems will enhance the efficacy and safety of tacrolimus[1].

Expanding Applications

The market will see expanded therapeutic applications, particularly in autoimmune disorders, and growing demand in emerging markets[1].

Integration of Pharmacogenomics

The integration of pharmacogenomics for optimized dosing regimens will further drive the market growth by improving patient outcomes and reducing adverse effects[1].

Key Takeaways

• The tacrolimus market is expected to grow significantly, driven by increasing organ transplant procedures and the prevalence of autoimmune diseases.
• Regulatory approvals, research investments, and advancements in drug delivery technologies are key drivers.
• The market faces challenges such as adverse effects and local competition.
• Future trends include personalized medicine approaches, expanding applications, and the integration of pharmacogenomics.

FAQs

What is the current market size of the tacrolimus market?

The global tacrolimus market was valued at approximately $6.6 billion in 2023[5].

What is the expected CAGR of the tacrolimus market from 2024 to 2032?

The market is expected to grow at a CAGR of 5.6% from 2024 to 2032[5].

What are the main applications of tacrolimus?

Tacrolimus is primarily used in immunosuppression for organ transplant recipients and also in treating autoimmune diseases like dermatitis[5].

Which region is expected to grow rapidly in the tacrolimus market?

The Asia Pacific region is expected to grow rapidly due to increasing awareness of organ donations and rising demand in countries like China, India, and Japan[5].

What are the major challenges facing the tacrolimus market?

The major challenges include adverse effects, local competition, and the effectiveness of alternative treatments[4].

Sources

1. The Business Research Company: Tacrolimus Market Share, Future Analysis Report 2024 To 2033
2. Astellas Pharma Inc.: Integrated Report 2023
3. News Channel Nebraska: Tacrolimus Consumption Market Growth 2024 Global Industry Size Analysis
4. Polaris Market Research: Tacrolimus Market Size, Share Trends Analysis Report, 2024-2032
5. Global Market Insights: Tacrolimus Market Size & Share, Growth Forecasts 2032