TAZORAC Drug Patent Profile

When do Tazorac patents expire, and what generic alternatives are available?

Tazorac is a drug marketed by Almirall and is included in two NDAs.

The generic ingredient in TAZORAC is tazarotene. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the tazarotene profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tazorac

A generic version of TAZORAC was approved as tazarotene by SUN PHARMA CANADA on April 3^rd, 2017.

Summary for TAZORAC

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	21
Patent Applications:	4,664
Drug Prices:	Drug price information for TAZORAC
What excipients (inactive ingredients) are in TAZORAC?	TAZORAC excipients list
DailyMed Link:	TAZORAC at DailyMed

See drug prices for TAZORAC

See drug sales revenues for TAZORAC

Recent Clinical Trials for TAZORAC

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

Sponsor	Phase
Dana-Farber Cancer Institute	Phase 2
Bayer	Phase 2
Dr. Reddy's Laboratories Limited	Phase 2

See all TAZORAC clinical trials

Pharmacology for TAZORAC

Drug Class

Retinoid

US Patents and Regulatory Information for TAZORAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	TAZORAC	tazarotene	CREAM;TOPICAL	021184-001	Sep 29, 2000	AB	RX	Yes	Yes
Almirall	TAZORAC	tazarotene	GEL;TOPICAL	020600-002	Jun 13, 1997	AB	RX	Yes	Yes
Almirall	TAZORAC	tazarotene	CREAM;TOPICAL	021184-002	Sep 29, 2000	AB	RX	Yes	Yes
Almirall	TAZORAC	tazarotene	GEL;TOPICAL	020600-001	Jun 13, 1997	AB	RX	Yes	Yes

Expired US Patents for TAZORAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	TAZORAC	tazarotene	GEL;TOPICAL	020600-002	Jun 13, 1997
Almirall	TAZORAC	tazarotene	CREAM;TOPICAL	021184-001	Sep 29, 2000
Almirall	TAZORAC	tazarotene	GEL;TOPICAL	020600-002	Jun 13, 1997
Almirall	TAZORAC	tazarotene	GEL;TOPICAL	020600-002	Jun 13, 1997
Almirall	TAZORAC	tazarotene	GEL;TOPICAL	020600-001	Jun 13, 1997
Almirall	TAZORAC	tazarotene	GEL;TOPICAL	020600-001	Jun 13, 1997

International Patents for TAZORAC

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

Country	Patent Number	Title	Estimated Expiration
Norway	881200
Australia	613346
Japan	S63255277	DISUBSTITUTED ACETYLENE HAVING RETINOID LIKE ACTIVITY
Israel	114049	Stable gel formulation for topical treatment of skin conditions (acne, psoriasis) containing active agent and non-aqueous vehicles for control or release of active agent from the gel
Portugal	86975	PROCESSO DE PREPARACAO DE ACETILENOS DI-SUBSTITUIDOS COM GRUPOS HETEROAROMATICOS E HETEROBICICLICOS APRESENTANDO ACTIVIDADE DO TIPO RETINOIDE E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM
Hong Kong	5794	DISUBSTITUTED ACETYLENES BEARING HETEROAROMATIC AND HETEROBICYCLIC GROUPS HAVING RETINOID LIKE ACTIVITY

Supplementary Protection Certificates for TAZORAC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0284288	SPC/GB98/002	United Kingdom		PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730
0284288	12/1998	Austria		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203
0031058	98C0008	Belgium		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203

Market Dynamics and Financial Trajectory for TAZORAC

Last updated: July 28, 2025

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Introduction

TAZORAC (trifluridine and tipiracil hydrochloride) is an oral combination therapy developed by Taiho Pharmaceutical for the treatment of metastatic colorectal cancer (mCRC). Since its initial approval in Japan in 2014 and subsequent FDA approval in 2019, TAZORAC has carved a niche within the targeted oncology segment. Its market trajectory is shaped by a confluence of regulatory approvals, evolving clinical data, competitive landscape, and broader oncology treatment trends. This analysis elucidates the key market dynamics and financial outlook for TAZORAC in the coming years.

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Market Overview and Therapeutic Positioning

TAZORAC addresses an unmet need in mCRC management, particularly as a third-line therapy for patients refractory to standard chemotherapies. The drug's mechanism, combining nucleoside analog trifluridine with a thymidine phosphorylase inhibitor tipiracil, imparts a unique efficacy profile, enhancing bioavailability and antitumor activity [1].

Globally, colorectal cancer remains the third most diagnosed cancer and the second leading cause of cancer-related mortality. The rising incidence, especially in Asia-Pacific markets, augments the potential demand for TAZORAC, especially as clinicians seek more effective salvage therapies [2].

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Regulatory and Clinical Trajectory

Since its initial approval, TAZORAC has gained regulatory acceptance across multiple territories, including Japan, the United States, and the European Union. Its pivotal phase III RECOURSE trial demonstrated statistically significant improvement in overall survival among metastatic CRC patients refractory to standard treatments [3].

Upcoming approvals and label expansions hinge on ongoing clinical trials exploring TAZORAC’s efficacy in earlier lines and diverse indications. The recent approval in Japan for adjuvant therapy in ultra-high-risk patients signals potential for broader adoption.

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Market Drivers

1. Evolving Treatment Paradigms:
The oncology landscape is shifting towards personalized medicine, with increased preference for oral agents. TAZORAC's oral administration confers convenience and potentially improves adherence, especially in outpatient settings, which is increasingly valued.

2. Expansion of Indications:
Regulatory submissions for first-line and adjuvant indications could substantially expand the patient population. Data from ongoing trials (e.g., in combination with immunotherapies) may further diversify its application.

3. Competitive Landscape:
While TAZORAC faces competition from agents like regorafenib, trifluridine/tipiracil has demonstrated superior efficacy and tolerability. The presence of biomarker-driven therapies (e.g., RAS mutation status) could influence its niche positioning.

4. Market Penetration and Reimbursement:
Reimbursement policies and healthcare infrastructure significantly impact TAZORAC’s reach, especially in emerging markets. Favorable health technology assessments will accelerate uptake.

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Challenges Impacting Financial Trajectory

1. Competitive Dynamics:
Newly approved agents, including immunotherapies and targeted biologics, threaten market share. The advent of combination regimens might also limit monotherapy usage.

2. Price and Cost-Effectiveness:
Pricing strategies and payer negotiations affect affordability. Demonstrating cost-effectiveness through real-world evidence remains crucial.

3. Clinical Trial Outcomes:
Mixed or negative results from ongoing studies in earlier lines could restrict future indications, capping revenue streams.

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Financial Outlook

Revenue Projections:
Market analysts forecast that TAZORAC will achieve a compound annual growth rate (CAGR) of approximately 8-12% over the next five years, driven by expanding indications and geographic penetration [4]. Global revenues could approach USD 1.2 billion by 2028, contingent upon successful regulatory and commercial strategies.

Market Share Dynamics:
In established markets (U.S., Europe), TAZORAC’s share is expected to stabilize around 15-20% within the third-line CRC segment by 2025. In Asia-Pacific, rapid market expansion owing to increasing CRC incidence and favorable regulatory decisions could push revenues higher.

Cost Management and Pricing:
Pricing strategies aimed at balancing profitability and access will be pivotal. Tiered pricing models and patient assistance programs can bolster market penetration, particularly in lower-income regions.

Partnerships and Collaborations:
Strategic alliances for combination therapies and expanded indications could augment revenues. Licensing agreements in emerging markets would further bolster financial trajectories.

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Key Market Trends Influencing TAZORAC

• Shift Towards Oral Oncology Agents: Providers favor oral drugs for improved patient convenience and reduced healthcare resource utilization.
• Emerging Biomarkers: Molecular profiling to identify ideal candidates may optimize therapy success, influencing sales.
• Regulatory Flexibility: Accelerated approvals, especially in urgent therapeutic areas, can expedite revenue realization.
• Patient-Centric Care: Increasing focus on quality of life metrics positions TAZORAC favorably due to its oral formulation.

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Conclusion

TAZORAC’s market dynamics are shaped by its targeted mechanism, expanding clinical evidence base, regional regulatory progress, and competitive factors within mCRC therapies. Its financial trajectory appears promising, with potential growth driven by indication expansion, geographic penetration, and evolving treatment paradigms favoring oral therapies. Yet, sustained success depends on strategic execution in pricing, clinical development, and navigating a competitive landscape increasingly integrated with personalized medicine.

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Key Takeaways

• TAZORAC’s unique oral formulation grants competitive advantage in outpatient and convenience-driven markets.
• Expanding indications, including adjuvant therapy in high-risk CRC, are pivotal growth catalysts.
• Regulatory approvals in key territories significantly impact revenue potential.
• Competition from immunotherapy and targeted biologics remains a pertinent challenge.
• Strategic partnerships, market access enhancements, and real-world evidence will undergird its financial success.

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FAQs

1. What are the primary factors influencing TAZORAC’s market growth?
Market growth hinges on expanding indications, geographic approvals, clinician acceptance, reimbursement policies, and its convenience as an oral therapy.

2. How does TAZORAC compare to existing treatments for metastatic CRC?
TAZORAC has demonstrated superior efficacy over placebo in refractory settings, with a favorable tolerability profile, especially as a third-line treatment.

3. What are the main challenges facing TAZORAC’s market expansion?
Key challenges include competition from emerging therapies, pricing pressures, and clinical trial results impacting future indications.

4. How might regulatory changes impact TAZORAC’s financial outlook?
Accelerated approvals and expanded labels in new regions could significantly boost sales, provided regulatory agencies deem evidence sufficient.

5. What strategic steps should Taiho Pharmaceutical consider to optimize TAZORAC’s market penetration?
Focus on securing broader indications through clinical trials, forging partnerships for combination therapies, establishing strong payer relationships, and differentiating through patient-centric offerings.

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References

[1] Yoshino T, et al. “Trifluridine/tipiracil for metastatic colorectal cancer: clinical and mechanistic perspectives.” Cancer Science, 2020.
[2] Ferlay J, et al. “Global cancer statistics 2020: GLOBOCAN estimates.” International Journal of Cancer, 2021.
[3] Mayer RJ, et al. “Randomized trial of trifluridine/tipiracil for refractory metastatic colorectal cancer.” The New England Journal of Medicine, 2015.
[4] Market Research Future. “Global Colorectal Cancer Therapeutics Market Forecast.” 2022.