PROTOPIC Drug Patent Profile

Which patents cover Protopic, and when can generic versions of Protopic launch?

Protopic is a drug marketed by Leo Pharma As and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Protopic

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

Summary for PROTOPIC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	110
Drug Prices:	Drug price information for PROTOPIC
Drug Sales Revenues:	Drug sales revenues for PROTOPIC
What excipients (inactive ingredients) are in PROTOPIC?	PROTOPIC excipients list
DailyMed Link:	PROTOPIC at DailyMed

See drug prices for PROTOPIC

See drug sales revenues for PROTOPIC

Recent Clinical Trials for PROTOPIC

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

Sponsor	Phase
Vanderbilt University Medical Center	Phase 1
Children's Oncology Group	Phase 3
Johns Hopkins University	Phase 3

See all PROTOPIC clinical trials

Pharmacology for PROTOPIC

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors

Paragraph IV (Patent) Challenges for PROTOPIC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 PROTOPIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-001	Dec 8, 2000	AB	RX	Yes	Yes
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-002	Dec 8, 2000	AB	RX	Yes	Yes

Expired US Patents for PROTOPIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-001	Dec 8, 2000	5,385,907
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-002	Dec 8, 2000	5,665,727
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-001	Dec 8, 2000	5,665,727
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-002	Dec 8, 2000	5,385,907

EU/EMA Drug Approvals for PROTOPIC

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

International Patents for PROTOPIC

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

Country	Patent Number	Title	Estimated Expiration
Austria	407957
European Patent Office	0474126	Onguents à base de composés tricycliques (Ointments containing tricyclic compound)
Sweden	8804036
Japan	H0517481	OINTMENT
Sweden	503236	Ny användning av 23,25-dimetoxi-13,19,21,27-tetrametyl-11,28- dioxa-4-azatricyclo]8(] 22.3.1.0]64]6.]69]8)]-]4oktakos-18-en -2,3,10,16-tetraon-derivat för framställning av läkemedel för topisk behandling av psoriasis och atopisk dermatit

PROTOPIC Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Protopic (Tacrolimus)

Introduction

Protopic, also known as tacrolimus, is a medication that belongs to the class of calcineurin inhibitors. It is widely used in organ transplant recipients to prevent organ rejection and in the treatment of various skin conditions, including atopic dermatitis. Here, we will delve into the market dynamics and financial trajectory of Protopic.

Market Size and Growth

The tacrolimus market, which includes Protopic, has been experiencing significant growth. As of 2023, the tacrolimus market size was valued at USD 6.6 billion and is expected to expand at a CAGR of 5.6% between 2024 and 2032, reaching USD 10.8 billion by 2032[1].

Key Drivers of Growth

Several factors are driving the growth of the tacrolimus market:

Increasing Organ Transplant Procedures

The rise in organ transplant procedures is a major driver. In 2022, the U.S. recorded a record-breaking 42,887 organ transplant procedures, highlighting the growing demand for immunosuppressive drugs like tacrolimus[1].

Prevalence of Autoimmune Diseases

The increasing prevalence of autoimmune diseases, such as atopic dermatitis, is another significant factor. The global atopic dermatitis treatment market, which includes tacrolimus, is anticipated to grow substantially due to the increasing incidence of atopic dermatitis and the launch of new treatments[4].

Advancements in Transplantation Medicine

Advancements in transplantation medicine and regulatory approvals for new indications are also contributing to the market's growth. Enhanced drug delivery technologies and expanded therapeutic applications further bolster the market[3].

Market Segmentation

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

Product Type

The market is segmented into injections, tablets and capsules, ointments, and granules. The injections segment is expected to reach USD 4.1 billion by 2032, indicating a strong demand for this formulation[1].

Application

The immunosuppression segment, which includes the use of tacrolimus in organ transplant patients, is poised to cross USD 6.4 billion by 2032. Other applications include dermatitis, where Protopic is widely used[1].

End-use

The hospital segment dominated the market with around USD 3.3 billion in revenue in 2023, reflecting the primary setting where tacrolimus is administered[1].

Regional Analysis

North America is a significant market for tacrolimus, accounting for USD 2.7 billion in revenue in 2023. This region is expected to witness substantial growth over the analysis period due to a large target population, higher treatment awareness, and better reimbursement policies[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 stay competitive[1].

Financial Performance of Protopic

While specific financial data for Protopic alone is not provided, the overall tacrolimus market performance gives insight into its financial trajectory. The market's CAGR of 5.6% between 2024 and 2032 indicates a steady and significant growth in revenue.

Impact of Generic Erosion

However, the market for atopic dermatitis treatments, which includes Protopic, is expected to face challenges from generic erosion. As generics become available, sales of branded products like Protopic may decline. For instance, the sales of current brand leaders like Protopic and Elidel are expected to decline due to the availability of generics[4].

Emerging Trends

Several trends are shaping the future of the tacrolimus market:

Personalized Medicine

Increased adoption of personalized medicine approaches and advancements in drug delivery systems are expected to drive growth. The integration of pharmacogenomics for optimized dosing regimens is also a key trend[3].

Expanding Applications

The market is expected to benefit from expanding applications in autoimmune disorders and rising demand in emerging markets. Growing emphasis on bioequivalence studies and the development of novel formulations will also contribute to market growth[3].

Regulatory Approvals

Regulatory approvals for new indications and growing awareness and acceptance of immunosuppressant therapies will further propel the market forward[3].

Quotes from Industry Experts

Industry experts highlight the importance of continuous innovation and regulatory support. For example:

"The growth in the forecast period can be attributed to expanded therapeutic applications, regulatory approvals for new indications, increased investment in research and development, growing awareness and acceptance of immunosuppressant therapies..."[3].

Illustrative Statistics

• The U.S. recorded 42,887 organ transplant procedures in 2022, with over 14,000 deceased organ donors contributing to more than 36,400 transplants[1].
• The global atopic dermatitis treatment market is anticipated to reach $31.7 billion by 2031, expanding at a CAGR of 14.1%[4].

Key Takeaways

• The tacrolimus market, including Protopic, is expected to grow significantly due to increasing organ transplant procedures and the prevalence of autoimmune diseases.
• The market is segmented by product type, application, and end-use, with the immunosuppression segment being the largest.
• North America is a key region for the market, driven by a large target population and better reimbursement policies.
• The market faces challenges from generic erosion but is expected to benefit from emerging trends such as personalized medicine and advancements in drug delivery systems.

FAQs

What is the primary use of Protopic (tacrolimus)?

Protopic, or tacrolimus, is primarily used in organ transplant recipients to prevent organ rejection by suppressing the immune system. It is also used in the treatment of skin conditions like atopic dermatitis.

What are the key drivers of the tacrolimus market growth?

The key drivers include the increasing number of organ transplant procedures, the prevalence of autoimmune diseases, advancements in transplantation medicine, and regulatory approvals for new indications.

How is the tacrolimus market segmented?

The market is segmented by product type (injections, tablets and capsules, ointments, and granules), application (immunosuppression, dermatitis, etc.), and end-use (hospitals, specialty clinics, etc.).

Which region dominates the tacrolimus market?

North America dominates the market, driven by a large target population, higher treatment awareness, and better reimbursement policies.

What challenges does the Protopic market face?

The market faces challenges from generic erosion, which may decline sales of branded products like Protopic as generics become available.

What are the emerging trends in the tacrolimus market?

Emerging trends include the adoption of personalized medicine approaches, advancements in drug delivery systems, expanding applications in autoimmune disorders, and growing emphasis on bioequivalence studies.

Sources

1. GMI Insights: Tacrolimus Market Size & Share, Growth Forecasts 2032
2. Protolabs: Protolabs Reports Financial Results for the Fourth Quarter and Full Year 2023
3. The Business Research Company: Tacrolimus Market Share, Future Analysis Report 2024 To 2033
4. iHealthcareAnalyst: Global Atopic Dermatitis Treatment Market $31.7 Billion by 2031
5. Protolabs: Protolabs Reports Financial Results for the Second Quarter of 2024