Tacrolimus - Generic Drug Details

What are the generic drug sources for tacrolimus and what is the scope of freedom to operate?

Tacrolimus is the generic ingredient in five branded drugs marketed by Astellas, Chengdu, Accord Hlthcare, Alkem Labs Ltd, Belcher, Biocon Pharma, Concord Biotech Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hangzhou Zhongmei, Heritage Pharma Avet, Mylan, Panacea, Sandoz, Strides Pharma, Hospira, Leo Pharma As, Encube, Fougera Pharms Inc, and Veloxis Pharms Inc, and is included in twenty-five NDAs. There are twenty-three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tacrolimus has sixty-six patent family members in twenty-four countries.

There are twenty drug master file entries for tacrolimus. Thirty-five suppliers are listed for this compound.

Summary for tacrolimus

International Patents:	66
US Patents:	23
Tradenames:	5
Applicants:	20
NDAs:	25
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	1,319
Patent Applications:	7,060
Drug Prices:	Drug price trends for tacrolimus
Drug Sales Revenues:	Drug sales revenues for tacrolimus
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tacrolimus
What excipients (inactive ingredients) are in tacrolimus?	tacrolimus excipients list
DailyMed Link:	tacrolimus at DailyMed

See drug prices for tacrolimus

See drug sales revenues for tacrolimus

Recent Clinical Trials for tacrolimus

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

Sponsor	Phase
Beijing Tsinghua Chang Gung Hospital	Phase 4
The Children's Hospital of Zhejiang University School of Medicine	Phase 3
AstraZeneca	Phase 3

See all tacrolimus clinical trials

Pharmacology for tacrolimus

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors

Medical Subject Heading (MeSH) Categories for tacrolimus

Calcineurin Inhibitors

Immunosuppressive Agents

Anatomical Therapeutic Chemical (ATC) Classes for tacrolimus

D11AH	Agents for dermatitis, excluding corticosteroids
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

L04AD	Calcineurin inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for TACROLIMUS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ENVARSUS XR	Extended-release Tablets	tacrolimus	0.75 mg, 1 mg and 4 mg	206406	1	2022-03-31
ASTAGRAF XL	Extended-release Capsules	tacrolimus	0.5 mg, 1 mg, and 5 mg	204096	1	2013-09-24
PROTOPIC	Ointment	tacrolimus	0.03%	050777	1	2010-11-22
PROTOPIC	Ointment	tacrolimus	0.10%	050777	1	2010-09-09

US Patents and Regulatory Information for tacrolimus

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015		RX	Yes	Yes
Accord Hlthcare	TACROLIMUS	tacrolimus	CAPSULE;ORAL	091195-003	Aug 31, 2011	BX	RX	No	No
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015		RX	Yes	Yes
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-001	Jul 10, 2015		RX	Yes	No			Y

Expired US Patents for tacrolimus

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-001	Jul 10, 2015
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015

EU/EMA Drug Approvals for tacrolimus

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

International Patents for tacrolimus

Country	Patent Number	Title	Estimated Expiration
Spain	2634153
Japan	4903568
Spain	2348640
Japan	2007504103

Tacrolimus Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tacrolimus

Introduction to Tacrolimus

Tacrolimus, a calcineurin inhibitor, is a crucial medication in the field of organ transplantation and the treatment of autoimmune diseases. It works by inhibiting T-cell proliferation, thereby preventing the rejection of transplanted organs and managing autoimmune conditions[5].

Current Market Size and Growth

The tacrolimus market has demonstrated robust growth in recent years. As of 2023, the market size was valued at approximately $6.6 billion. This figure is expected to increase significantly, with projections indicating a market size of $6.59 billion in 2024 and $8.47 billion by 2028, reflecting a compound annual growth rate (CAGR) of 6.5% during the forecast period[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the tacrolimus market:

Increasing Organ Transplant Procedures

The rise in organ transplant procedures, driven by factors such as the increasing prevalence of end-stage organ failure, heightened awareness about organ donation, and advancements in procedural technology, is a significant driver. For instance, the United States recorded a record-breaking 42,887 organ transplant procedures in 2022[4].

Advancements in Transplantation Medicine

Advancements in transplantation medicine, including improved immunosuppressive regimens and better post-transplant care, have increased the success rates of organ transplants, thereby boosting the demand for tacrolimus[1].

Expanded Therapeutic Applications

Tacrolimus is not only used in organ transplantation but also in the treatment of autoimmune diseases and dermatological conditions. This expanded application base contributes to the market's growth[1][4].

Regulatory Approvals and Research Investments

Regulatory approvals for new indications and increased investments in research and development are further propelling the market. The integration of pharmacogenomics for optimized dosing regimens and the development of novel formulations are also significant trends[1].

Growing Awareness and Acceptance

Growing awareness and acceptance of immunosuppressant therapies, particularly in emerging markets, are driving the demand for tacrolimus. Expanding healthcare infrastructure in these regions also supports market growth[1].

Market Segmentation

The tacrolimus market is segmented based on several criteria:

By Product Type

The market is segmented into injections, tablets and capsules, ointments, and granules. The injections segment is expected to reach $4.1 billion by 2032, indicating a strong preference for this formulation[4].

By Application

The primary applications include immunosuppression, dermatitis, and other conditions. The immunosuppression segment is poised to cross $6.4 billion by 2032, reflecting the dominant use of tacrolimus in organ transplantation[4].

By End-Use

The market is categorized into hospitals, specialty clinics, and other end-use segments. Hospitals dominated the market with around $3.3 billion in revenue in 2023[4].

Regional Market Dynamics

North America

North America accounted for $2.7 billion in revenue in 2023 and is predicted to witness substantial growth over the analysis period. The region's advanced healthcare infrastructure and high adoption rates of immunosuppressant therapies contribute to its significant market share[4].

Emerging Markets

Emerging markets are also expected to play a crucial role in the growth of the tacrolimus market. Expanding healthcare infrastructure and growing awareness about organ transplantation and autoimmune diseases are key factors driving growth in these regions[1].

Competitive Landscape

The tacrolimus market is competitive, with several large multinationals and small to mid-sized companies. Key players include Abbott Laboratories, Astellas Pharma Inc., Novartis AG, Biocon Ltd., and Glenmark Pharmaceuticals Ltd. These companies are focusing on the development and launch of novel advanced products based on different formulations to maintain their market presence[4].

Financial Trajectory

Historical Performance

The tacrolimus market has experienced strong growth in the historic period, driven by advancements in transplantation medicine, increased organ transplant procedures, and expanded applications in dermatology and autoimmune diseases[1].

Future Projections

The market is expected to continue its upward trajectory, with a projected CAGR of 5.6% between 2024 and 2032. By 2032, the market size is anticipated to reach $10.8 billion[4].

Cost and Economic Considerations

Studies have shown that tacrolimus, when combined with other immunosuppressive agents, is comparable in safety, efficacy, and cost to other immunosuppressants like cyclosporine. For instance, a randomized prospective study found that the total 12-month medication costs for tacrolimus and cyclosporine were similar[2].

Challenges and Pitfalls

COVID-19 Impact

The COVID-19 pandemic had a significant impact on the tacrolimus market, leading to a decline in transplant procedures globally. However, the market is expected to recover as treatment guidelines and precautionary measures have been implemented[3].

Toxicity and Side Effects

Tacrolimus toxicity can present as acute renal failure, tremors, electrolyte disturbances, and other adverse effects. Close monitoring of patients is necessary to manage these risks[5].

Key Takeaways

• The tacrolimus market is expected to grow significantly, driven by increasing organ transplant procedures and expanded therapeutic applications.
• The market is segmented by product type, application, and end-use, with injections and immunosuppression being key segments.
• North America and emerging markets are crucial for the market's growth.
• The competitive landscape is dominated by major pharmaceutical companies focusing on novel formulations and pharmacogenomics.
• The market is expected to reach $10.8 billion by 2032, with a CAGR of 5.6% between 2024 and 2032.

FAQs

Q: What is the primary use of tacrolimus?

A: Tacrolimus is primarily used in organ transplant recipients to prevent the rejection of the transplanted organ by suppressing the immune system.

Q: How is the tacrolimus market expected to grow in the coming years?

A: The tacrolimus market is expected to grow at a CAGR of 5.6% between 2024 and 2032, reaching a market size of $10.8 billion by 2032.

Q: What are the key drivers of the tacrolimus market growth?

A: Key drivers include increasing organ transplant procedures, advancements in transplantation medicine, expanded therapeutic applications, and growing awareness and acceptance of immunosuppressant therapies.

Q: Which regions are significant for the tacrolimus market?

A: North America and emerging markets are crucial for the growth of the tacrolimus market due to their advanced healthcare infrastructure and growing awareness about organ transplantation.

Q: What are the potential side effects of tacrolimus?

A: Tacrolimus can cause acute renal failure, tremors, electrolyte disturbances, and other adverse effects, necessitating close monitoring of patients.

Sources

1. The Business Research Company. Tacrolimus Market Share, Future Analysis Report 2024 To 2033.
2. PubMed. A randomized, prospective, pharmacoeconomic trial of tacrolimus versus cyclosporine modified in a quadruple immunosuppressive regimen.
3. Mordor Intelligence. Global Tacrolimus Market Size - Mordor Intelligence.
4. GMI Insights. Tacrolimus Market Size & Share, Growth Forecasts 2032.
5. NCBI Bookshelf. Tacrolimus - StatPearls.