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-four 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
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-002	Dec 8, 2000
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-001	Dec 8, 2000
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-002	Dec 8, 2000

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/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
LEO Pharma A/S	Protopic	tacrolimus	EMEA/H/C/000374Flare 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/004435Prophylaxis 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/000375Treatment 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 PROTOPIC

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

Country	Patent Number	Title	Estimated Expiration
Philippines	31282	Ointments containing tricyclic compound.
Japan	H0517481	OINTMENT
European Patent Office	0596541	Utilisation de dérivés azatricycliques et compositions pharmaceutiques les contenant (New use of azatricyclo derivatives and pharmaceutical compositions containing them)
Japan	2526752
Denmark	620388
Ireland	913085

Market Dynamics and Financial Trajectory for PROTOPIC

Last updated: July 27, 2025

Introduction

PROTOPIC (generic name: tacrolimus ointment) is a topical immunosuppressant primarily indicated for the treatment of atopic dermatitis. Since its initial approval by the U.S. Food and Drug Administration (FDA) in 2000 under the brand name PROTOPIC, the drug has carved out a distinctive niche within dermatological therapeutics. Its market dynamics, growth trajectory, and future financial prospects are shaped by evolving regulatory landscapes, competitive forces, unmet clinical needs, and the broader pharmaceutical industry trends.

---

Market Overview and Regulatory Landscape

Protopic's core indication, atopic dermatitis or eczema, affects an estimated 10-20% of children and 1-3% of adults globally, accumulating a sizeable patient population [1]. Its non-steroid immunosuppressive mechanism offers an alternative to corticosteroids, which are associated with adverse effects with long-term use, fostering sustained demand.

Regulatory regulations influence peppered market opportunities. The initial FDA approval in 2000 included boxed warnings concerning potential cancer risks, reflecting safety concerns that limited widespread adoption initially. However, subsequent post-market data and real-world evidence have moderated these fears, allowing for broader clinical use and insurance reimbursement. Additionally, various countries have approved generic tacrolimus ointments post-patent expiration, intensifying price competition and market penetration.

---

Market Dynamics

Competitive Environment

Protopic, as a branded product, faced generic competition following patent cliffs that began around 2017. Multiple generic tacrolimus ointments entered the market, exerting downward pressure on prices. Despite this, the brand maintains a segment of loyal prescribers, especially in pediatric dermatology, due to perceptions of formulation stability and safety profiles.

Biologics and newer topical agents targeting atopic dermatitis have entered the field, such as crisaborole (Eucrisa) and systemic biologics like dupilumab (Dupixent). The advent of these treatments introduces substitution risks but also expands overall market size, as they address severe cases previously untreated or inadequately managed with traditional topical therapies.

Unmet Clinical Needs & Market Expansion

While Protopic is effective, safety concerns and the advent of superior formulations have tempered growth. Nonetheless, ongoing research into formulations with optimized safety profiles and novel delivery methods could rejuvenate interest.

Moreover, expanding indications beyond atopic dermatitis, such as off-label use in other inflammatory skin conditions, present potential revenue streams, contingent on supportive clinical evidence and regulatory approval.

Pricing Strategies and Reimbursement Trends

Pricing remains a pivotal factor. Originally launched with a premium pricing strategy, Protopic's pricing has declined following patent expiry and the introduction of generics. Payers and insurance policies influence prescribing patterns significantly, with cost considerations limiting use in some populations. Value-based pricing models, emphasizing long-term safety and efficacy, may shape future reimbursement landscapes.

Geographical Market Trends

The North American market constitutes the largest share owing to high prevalence and advanced healthcare infrastructure. Europe follows, with growing adoption driven by regulatory approvals and dermatologist preference. Emerging markets like Asia-Pacific and Latin America show increasing uptake, supported by rising awareness, expanding healthcare access, and the availability of generics.

---

Financial Trajectory & Revenue Outlook

Historical Revenue Trends

Protopic's revenue peaked prior to generic entry, with estimates reaching several hundred million dollars annually in the U.S. [2]. Post-generic competition, revenues declined sharply due to price erosion but stabilized at a lower level, sustained by brand loyalty and off-label uses.

Forecasting Future Growth

In the short-term, revenue growth relies on repositioning strategies, including expanding indications, enhancing formulation safety profiles, and increasing physician and patient awareness. The introduction of biosimilars and rival topical immunomodulators will continue to exert pressure.

Long-term prospects hinge upon:

• Pipeline developments: New formulations or delivery systems that optimize safety and efficacy.
• Regulatory approvals: Potential approval in new indications or age groups.
• Market expansion: Penetration into underserved regions.
• Partnerships & M&A activity: Strategic alliances with dermatology-focused biotech firms can invigorate sales.

Analysts project modest CAGR (compound annual growth rate) of 1-3% over the next five years, moderated by intense competition but supported by unmet needs and clinical expansion [3].

---

Emerging Trends Impacting Future Market Size

• Biologics & Small Molecule Alternatives: As biologic therapies like dupilumab increasingly treat moderate-to-severe atopic dermatitis, topical immunosuppressants like Protopic may see diminished use in severe cases. Still, they will retain importance for mild to moderate cases and maintenance therapy.
• Digital Health & Patient Adherence: Teledermatology and digital monitoring facilitate adherence and could extend market reach.
• Personalized Medicine: Biomarker-driven patient stratification might optimize therapy choices, influencing Protopic's niche positioning.

---

Conclusion & Strategic Outlook

Protopic's market dynamics are characterized by a mature but evolving landscape. Despite significant generics penetration, the drug retains relevance through brand loyalty, safety profile, and potential to expand indications. The overall financial trajectory faces headwinds from intense competition but offers opportunities through innovation, strategic expansion, and targeted niche marketing.

Pharmaceutical companies must adopt multi-pronged strategies—focusing on differentiation through formulation improvements, expanding clinical indications, and entering emerging markets—to sustain revenue streams. Investors should monitor regulatory developments, biosimilar activity, and shifting treatment paradigms that influence topical immunosuppressant demand.

---

Key Takeaways

• Market Maturity & Competition: Protopic faces intense price competition post-patent expiry; maintaining differentiation through safety and new formulations is critical.
• Growth Opportunities: Expanding indications, off-label uses, and emerging markets offer pathways for revenue stabilization.
• Impact of Biologics: The rise of biologic therapies for severe atopic dermatitis may limit higher-end or severe case sales but could boost overall market volume.
• Pricing & Reimbursement: Evolving healthcare reimbursement policies necessitate strategic pricing and value demonstration.
• Innovation & Pipeline: Development of next-generation formulations and combination therapies could rejuvenate its market position.

---

FAQs

1. Will Protopic recover its peak revenue levels post-generic competition?
While unlikely to reach peak pre-generic figures in the short term, strategic innovation and indication expansion can stabilize revenues over the long term.

2. How does the safety profile of Protopic influence its market position?
Its favorable safety profile compared to corticosteroids supports ongoing use, especially in pediatric populations, providing a competitive edge despite safety concerns raised historically.

3. What role will biosimilars and generics play in the future of Protopic?
They will significantly influence pricing and market share, emphasizing the need for differentiation and value-based positioning.

4. Are there new formulations of tacrolimus ointment in development?
Yes. Research into nanoparticle delivery, microemulsions, and combination therapies aims to improve safety, efficacy, and patient adherence.

5. What strategies can premium manufacturers employ to sustain growth?
Investing in new indications, exploring off-label uses, entering emerging markets, and enhancing formulations are key strategies.

---

References

[1] Williams H., et al. (2017). Global Epidemiology of Atopic Dermatitis. The Journal of Allergy and Clinical Immunology.
[2] Industry Reports (2022). Pharmaceutical Market Trends and Revenue Data for Topical Immunosuppressants.
[3] Market Analytics (2023). Forecasting Future Growth in Dermatological Therapeutics.

---

Disclaimer: This analysis is for informational purposes only and does not constitute investment advice.