TAFLUPROST - Generic Drug Details

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

Tafluprost is the generic ingredient in two branded drugs marketed by Ingenus Pharms Llc, Micro Labs, Sandoz, and Thea Pharma, and is included in four NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Tafluprost has eighty-five patent family members in twenty-six countries.

There are three drug master file entries for tafluprost. Five suppliers are listed for this compound.

Summary for TAFLUPROST

International Patents:	85
US Patents:	2
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	29
Patent Applications:	1,958
Drug Prices:	Drug price trends for TAFLUPROST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TAFLUPROST
What excipients (inactive ingredients) are in TAFLUPROST?	TAFLUPROST excipients list
DailyMed Link:	TAFLUPROST at DailyMed

See drug prices for TAFLUPROST

Recent Clinical Trials for TAFLUPROST

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

Sponsor	Phase
Fondazione G.B. Bietti, IRCCS	Phase 4
Tun Hussein Onn National Eye Hospital	Phase 4
Taejoon Pharmaceutical Co., Ltd.	Phase 4

See all TAFLUPROST clinical trials

Pharmacology for TAFLUPROST

Drug Class	Prostaglandin Analog
Mechanism of Action	Prostaglandin Receptor Agonists
Physiological Effect	Increased Prostaglandin Activity

Anatomical Therapeutic Chemical (ATC) Classes for TAFLUPROST

S01EE	Prostaglandin analogues
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for TAFLUPROST

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZIOPTAN	Ophthalmic Solution	tafluprost	0.0015%	202514	2	2016-02-10

US Patents and Regulatory Information for TAFLUPROST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Thea Pharma	ZIOPTAN	tafluprost	SOLUTION/DROPS;OPHTHALMIC	202514-001	Feb 10, 2012	AT	RX	Yes	Yes	9,999,593		Y
Micro Labs	TAFLUPROST	tafluprost	SOLUTION/DROPS;OPHTHALMIC	209051-001	Aug 19, 2019	AT	RX	No	No
Sandoz	TAFLUPROST	tafluprost	SOLUTION/DROPS;OPHTHALMIC	209040-001	Jan 28, 2022	AT	RX	No	No
Ingenus Pharms Llc	TAFLUPROST	tafluprost	SOLUTION/DROPS;OPHTHALMIC	218002-001	Apr 5, 2024	AT	RX	No	No
Thea Pharma	ZIOPTAN	tafluprost	SOLUTION/DROPS;OPHTHALMIC	202514-001	Feb 10, 2012	AT	RX	Yes	Yes	10,864,159		Y

Expired US Patents for TAFLUPROST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Thea Pharma	ZIOPTAN	tafluprost	SOLUTION/DROPS;OPHTHALMIC	202514-001	Feb 10, 2012	5,886,035

International Patents for TAFLUPROST

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3714877	PROCÉDÉ ET COMPOSITION POUR LE TRAITEMENT DE L'HYPERTENSION OCULAIRE ET DU GLAUCOME (METHOD AND COMPOSITION FOR TREATING OCULAR HYPERTENSION AND GLAUCOMA)
South Korea	101988642
Argentina	120961	MÉTODO Y COMPOSICIÓN PARA TRATAR HIPERTENSIÓN OCULAR Y GLAUCOMA
Canada	2724194
Jordan	3039
Brazil	PI0913109

Supplementary Protection Certificates for TAFLUPROST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0850926	11C0020	France		PRODUCT NAME: TAFLUPROST; REGISTRATION NO/DATE IN FRANCE: CIS:6 000 728 O DU 20110328; REGISTRATION NO/DATE AT EEC: 43230 DU 20080430
0850926	C00850926/01	Switzerland		PRODUCT NAME: TAFLUPROST; REGISTRATION NO/DATE: SWISSMEDIC 60548 27.01.2010
0850926	SPC/GB09/005	United Kingdom		PRODUCT NAME: TAFLUPROST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: DK 43230 20080430; UK PL 16058/0011-0001 20081017

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Tafluprost

Last updated: July 27, 2025

---

Introduction

Tafluprost, a prostaglandin analog used primarily in glaucoma and ocular hypertension management, has garnered significant attention in ophthalmic pharmacology. As a topical agent, it functions by increasing aqueous humor outflow to reduce intraocular pressure (IOP), thereby safeguarding against optic nerve damage. This comprehensive analysis explores the evolving market dynamics and the projected financial trajectory for tafluprost, considering its therapeutic advantages, competitive landscape, regulatory environment, and commercial potential.

---

Pharmacological Profile and Clinical Positioning

Tafluprost distinguishes itself from other prostaglandin analogs through its efficacy, safety profile, and unique formulation features. Approved in multiple regions, including Japan, Europe, and the United States (under the name Zioptan), tafluprost is notable for its preservative-free formulation, which minimizes ocular surface irritation—a critical factor influencing patient compliance.

Clinically, tafluprost has demonstrated comparable IOP reduction to established agents such as latanoprost and bimatoprost. Its safety profile, particularly regarding conjunctival hyperemia and eyelash growth, remains favorable, reinforcing its position as a first-line therapy.

---

Market Dynamics

1. Growing Global Prevalence of Glaucoma and Ocular Hypertension

The global burden of glaucoma exceeds 76 million individuals, with projections reaching over 111 million by 2040. This increasing prevalence drives sustained demand for effective IOP-lowering therapies like tafluprost. The aging population worldwide exacerbates this trend, particularly in developed countries where glaucoma management aligns closely with the rising prevalence of age-related ocular conditions.

2. Increased Adoption Driven by Preservative-Free Formulations

Patients with ocular surface diseases and sensitivities prefer preservative-free options. Notably, tafluprost’s preservative-free formulation appeals to this segment, boosting its adoption among clinicians aiming to optimize patient tolerability and compliance.

3. Regulatory Approvals and Market Penetration

Initially launched in Japan in 2007, tafluprost gained regulatory approval in Europe in 2012 and the U.S. in 2016. Its early entry into mature markets facilitated initial sales, but late entry relative to competitors like latanoprost and travoprost limited market share in some regions. Nonetheless, its niche positioning as a preservative-free anti-glaucoma agent enhances its growth prospects.

4. Competitive Landscape

The prostaglandin analog class is highly competitive, with established blockbusters such as latanoprost (Xalatan), travoprost (Travatan), and bimatoprost (Lumigan). Tafluprost competes by emphasizing its preservative-free benefit, especially in patients intolerant to preservatives.

Emerging agents, including rock inhibitors and combination therapies, pose potential threats by offering simplified or synergistic approaches. However, the specificity, safety profile, and patient preference for tafluprost remain significant advantages.

5. Market Challenges and Limitations

Pricing strategies, reimbursement policies, and formulary placements influence tafluprost’s market penetration. Limited awareness among clinicians unfamiliar with its unique formulation may hinder rapid adoption. Additionally, patent expirations, if any, could impact pricing and market share.

---

Financial Trajectory and Forecasting

1. Revenue Projections and Market Share

The global glaucoma drug market is projected to reach USD 5.8 billion by 2025, growing at a compound annual growth rate (CAGR) of approximately 4-6% (Source: MarketWatch). Tafluprost, currently holding a modest market share, is poised to expand as prescribing trends favor preservative-free therapies.

Considering its current sales trajectory, extrapolated growth hinges on factors such as:

• Geographical expansion: Increasing approvals in emerging markets.
• Prescriber education: Elevating awareness of its benefits.
• Patient preference shifts: Favoring preservative-free formulations.

Assuming a conservative CAGR of 8% for tafluprost within its niche segment, revenues could approach USD 200-300 million globally within five years, particularly if broader indications and combination products gain regulatory approval.

2. Pricing Dynamics and Reimbursement Landscape

Pricing remains a critical factor; tafluprost commands premium pricing in markets where preservative-free formulations are deemed essential. Reimbursement policies and insurance coverage influence uptake, especially in the U.S. and Europe where healthcare payers favor cost-effective, evidence-backed therapies.

3. Strategic Collaborations and Market Expansion

Partnerships with regional pharmaceutical firms and ophthalmology networks could accelerate market penetration. Licensing agreements for biosimilar or combination formulations may further enhance financial prospects.

4. Potential for Indication Expansion

Research exploring tafluprost’s utility in additional ocular conditions or as part of combination therapies could diversify revenue streams. Novel delivery systems, such as sustained-release implants, may also augment long-term sales.

---

Regulatory and Commercial Outlook

Regulators’ acceptance of preservative-free formulations, coupled with innovation in drug delivery, positions tafluprost favorably. The global shift toward personalized and tolerability-focused therapies suggests steady demand growth.

Commercially, companies investing in clinician education, patient awareness, and healthcare provider engagement are more likely to succeed in expanding tafluprost’s footprint.

---

Conclusion

Tafluprost’s market dynamics are driven by its differentiation as a preservative-free prostaglandin analog amid an expanding glaucoma population. Its financial trajectory appears promising, supported by increasing global prevalence, rising adoption of preservative-free formulations, and strategic market expansion. However, challenges persist from established competitors, pricing pressures, and regulatory hurdles.

As the ophthalmic pharmaceutical landscape evolves, tafluprost’s niche positioning and continued innovation will be key determinants of its long-term financial performance.

---

Key Takeaways

• Growing Patient Demographics: The rising global prevalence of glaucoma underpins ongoing demand for tafluprost and similar therapies.
• Unique Value Proposition: Its preservative-free formulation enhances patient tolerability, increasing its appeal amid a crowded market.
• Market Expansion Potential: Geographical and indication expansion, alongside strategic partnerships, can significantly boost revenues.
• Competitive Challenges: Dominance of existing prostaglandin analogs necessitates focused marketing and clinician education.
• Forecasted Growth: With cautious estimates, tafluprost’s revenues could approach triple digits in millions globally within five years, contingent on regulatory, market, and innovation factors.

---

FAQs

1. How does tafluprost differ from other prostaglandin analogs?
Tafluprost is distinct as a preservative-free formulation, reducing ocular surface irritation and improving tolerability, especially in sensitive patients, which can enhance adherence compared to preserved formulations.

2. What are the primary barriers to increasing tafluprost’s market share?
Barriers include strong brand loyalty to established agents like latanoprost, pricing and reimbursement policies, clinician awareness gaps, and limited geographic approval.

3. Is tafluprost approved for use in all major markets?
No. While approved in Japan, Europe, and the U.S., regulatory approvals are pending or absent in several emerging markets, limiting its global reach.

4. What future developments could impact tafluprost’s financial trajectory?
Advances in combination therapies, sustained-release formulations, and expanded indications can positively influence its revenue. Conversely, new competitors or biosimilars could exert pressure.

5. How significant is patient preference for preservative-free therapies in market growth?
Very significant. As clinicians recognize the benefits, patient demand for preservative-free formulations like tafluprost is expected to fuel adoption and drive revenue growth.

---

References

[1] Global Burden of Glaucoma. (2021). International Journal of Ophthalmology.
[2] MarketWatch. (2022). Glaucoma Drugs Market Size, Share & Trends.
[3] European Medicines Agency. (2012). Summary of Product Characteristics for Tafluprost.
[4] U.S. Food and Drug Administration. (2016). FDA Approval for Zioptan (Tafluprost).
[5] Research and Markets. (2021). Ophthalmic Drugs Market Analysis.