Travoprost - Generic Drug Details

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

Travoprost is the generic ingredient in five branded drugs marketed by Glaukos, Novartis, Alcon Pharms Ltd, Sandoz, Alembic, Apotex, Chartwell Rx, Gland, Lupin Ltd, Micro Labs, Mylan, and Somerset Theraps Llc, and is included in twelve NDAs. There are eleven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Travoprost has one hundred and thirty-seven patent family members in twenty-five countries.

There are fifteen drug master file entries for travoprost. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for travoprost

International Patents:	137
US Patents:	11
Tradenames:	5
Applicants:	12
NDAs:	12
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	107
Patent Applications:	7,692
Drug Prices:	Drug price trends for travoprost
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for travoprost
What excipients (inactive ingredients) are in travoprost?	travoprost excipients list
DailyMed Link:	travoprost at DailyMed

See drug prices for travoprost

See drug sales revenues for travoprost

Recent Clinical Trials for travoprost

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

Sponsor	Phase
Salus University	Phase 4
Glaukos Corporation	PHASE2
Assiut University	Phase 4

See all travoprost clinical trials

Generic filers with tentative approvals for TRAVOPROST

Applicant	Application No.	Strength	Dosage Form
		0.004%	SOLUTION; OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for travoprost

Drug Class

Prostaglandin Analog

Medical Subject Heading (MeSH) Categories for travoprost

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for travoprost

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

Paragraph IV (Patent) Challenges for TRAVOPROST

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IZBA	Ophthalmic Solution	travoprost	0.003%	204822	1	2015-12-30
TRAVATAN Z	Ophthalmic Solution	travoprost	0.004%	021994	1	2009-02-19
TRAVATAN	Ophthalmic Solution	travoprost	0.004%	021257	1	2008-11-28

US Patents and Regulatory Information for travoprost

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaukos	IDOSE TR	travoprost	IMPLANT;INTRACAMERAL	218010-001	Dec 13, 2023		RX	Yes	Yes			Y	Y
Sandoz	TRAVATAN Z	travoprost	SOLUTION/DROPS;OPHTHALMIC	021994-001	Sep 21, 2006	AT2	RX	Yes	Yes			Y
Somerset Theraps Llc	TRAVOPROST	travoprost	SOLUTION/DROPS;OPHTHALMIC	217228-001	Sep 23, 2024	AT2	RX	No	No
Glaukos	IDOSE TR	travoprost	IMPLANT;INTRACAMERAL	218010-001	Dec 13, 2023		RX	Yes	Yes			Y	Y
Lupin Ltd	TRAVOPROST	travoprost	SOLUTION/DROPS;OPHTHALMIC	207040-001	May 3, 2024		DISCN	No	No
Apotex	TRAVOPROST	travoprost	SOLUTION/DROPS;OPHTHALMIC	203431-001	Jul 10, 2015	AT2	RX	No	No
Mylan	TRAVOPROST	travoprost	SOLUTION/DROPS;OPHTHALMIC	205050-001	Jul 7, 2017	AT2	RX	No	No

Expired US Patents for travoprost

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	TRAVATAN Z	travoprost	SOLUTION/DROPS;OPHTHALMIC	021994-001	Sep 21, 2006
Alcon Pharms Ltd	TRAVATAN	travoprost	SOLUTION/DROPS;OPHTHALMIC	021257-001	Mar 16, 2001
Sandoz	TRAVATAN Z	travoprost	SOLUTION/DROPS;OPHTHALMIC	021994-001	Sep 21, 2006
Alcon Pharms Ltd	TRAVATAN	travoprost	SOLUTION/DROPS;OPHTHALMIC	021257-001	Mar 16, 2001
Sandoz	TRAVATAN Z	travoprost	SOLUTION/DROPS;OPHTHALMIC	021994-001	Sep 21, 2006
Alcon Pharms Ltd	TRAVATAN	travoprost	SOLUTION/DROPS;OPHTHALMIC	021257-001	Mar 16, 2001
Alcon Pharms Ltd	TRAVATAN	travoprost	SOLUTION/DROPS;OPHTHALMIC	021257-001	Mar 16, 2001

EU/EMA Drug Approvals for travoprost

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Izba	travoprost	EMEA/H/C/002738Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1). Decrease of elevated intraocular pressure in paediatric patients aged 3 years to < 18 years with ocular hypertension or paediatric glaucoma.	Authorised	no	no	no	2014-02-20
Novartis Europharm Limited	Travatan	travoprost	EMEA/H/C/000390Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1).Decrease of elevated intraocular pressure in paediatric patients aged 2 months to < 18 years with ocular hypertension or paediatric glaucoma (see section 5.1).	Authorised	no	no	no	2001-11-27

International Patents for travoprost

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2967984
Austria	E531358
Hungary	E025619
Japan	2022166178	制御薬物送達の特徴を有する移植片及びそれを使用する方法
World Intellectual Property Organization (WIPO)	2012071476
Japan	2013234199
Spain	2542728

Supplementary Protection Certificates for travoprost

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1920764	PA2012017	Lithuania		PRODUCT NAME: TRAVOPROSTUM; NAT. REGISTRATION NO/DATE: LT 02/7821/3 20020402; FIRST REGISTRATION: EU/1/01/199/001 - EU/1/01/199/002 20011127
1514548	C300671	Netherlands		PRODUCT NAME: TRAVOPROST; REGISTRATION NO/DATE: EG EU/1/01/199/001-002 20011128
1920764	C300540	Netherlands		PRODUCT NAME: TRAVOPROST; REGISTRATION NO/DATE: EU/1/01/199/001-002 20011127
1920764	PA2012017,C1920764	Lithuania		PRODUCT NAME: TRAVOPROSTUM; NAT. REGISTRATION NO/DATE: LT 02/7821/3 20020402; FIRST REGISTRATION: EU/1/01/199/001 - EU/1/01/199/002 20011127
1920764	12C0045	France		PRODUCT NAME: TRAVOPROST; REGISTRATION NO/DATE: EU/1/01/199/001 20011127
1920764	2012/033	Ireland		PRODUCT NAME: TRAVOPROST (ALSO CALLED FLUPROSTENOL ISOPROPYL ESTER); NAT REGISTRATION NO/DATE: EU/1/01/199/001-002 20011129; FIRST REGISTRATION NO/DATE: EU/1/01/199/001-002 20011129; PAEDIATRIC INVESTIGATION PLAN: P/0298/2013 PROCEEDINGS UNDER SECTION 37 OF THE PATENTS ACT, 1992 RESTORATION ORDER DATED 12TH JANUARY 2016, WAS MADE RESTORING THE PATENT MENTIONED BELOW S85583 PAUL DOYLE A RE-USABLE BAG SYSTEM RESTORATION ORDERS DATED 16TH FEBRUARY 2016, WERE MADE RESTORING THE PATENTS MENTIONED BELOW S86133 MERVYN GREENE MULTI PURPOSE TANK STAND WITH COMPLEX LOCKING MECHANISM 86119 MPC GREEN LIMITED ANEW BIN
1514548	CA 2014 00038	Denmark		PRODUCT NAME: TRAVOPROST; REG. NO/DATE: EU/1/01/199/001-002 20011127

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TRAVOPROST

Last updated: October 16, 2025

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Introduction

Travoprost, a prostaglandin analogue primarily used for reducing intraocular pressure (IOP) in glaucoma and ocular hypertension patients, has carved a significant niche within ophthalmologic therapeutics. As the global prevalence of glaucoma surges, driven by aging populations and increasing chronic disease burdens, the market for Travoprost and its competitors experiences notable shifts. Understanding the evolving market dynamics and financial trajectory of Travoprost involves examining regulatory landscapes, competitive positioning, patent statuses, clinical data, and regional adoption trends.

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Market Overview: Epidemiological Drivers and Therapeutic Demand

Glaucoma affects an estimated 76 million worldwide, with projections indicating a rise to over 111 million by 2040 [1]. Elevated IOP remains the only treatable risk factor, positioning prostaglandin analogues like Travoprost as first-line agents. Their efficacy, safety profile, and once-daily dosing confer advantages over older therapies such as beta-blockers.

Regional disparities significantly influence market growth. North America, with high awareness, advanced healthcare infrastructure, and restructured reimbursement, accounts for a substantial revenue share. The Asia-Pacific region, driven by increasing urbanization and aging demographics, offers emerging growth opportunities despite challenges around affordability and healthcare access [2].

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Market Dynamics

1. Competitive Landscape

Travoprost competes with other prostaglandin analogues like Latanoprost and Bimatoprost, alongside fixed-dose combination drugs. Major pharmaceutical firms such as Alcon, Santen Pharmaceutical, and Ajanta Pharma dominate the market, developing proprietary formulations and novel delivery systems.

The launch of preservative-free formulations (e.g., Travoprost with sofZia preservative by Alcon) has enhanced patient tolerability and adherence, thereby influencing market demand [3].

2. Patent Expiration and Generic Entry

While Travoprost’s initial patents provided exclusivity, patent expirations have introduced generic versions, intensifying price competition. For example, Alcon's Travatan Z’s patent expiry in multiple territories has opened market segments to generics, exerting downward pressure on prices and profit margins [4].

3. Regulatory Influences

Regulatory approvals for generic versions vary by region. The U.S. FDA approved several generics post-patent expiry, facilitating increased accessibility and volume sales but challenging branded formulations. Conversely, regulatory delays or restrictions in certain markets continue to influence revenue stability.

4. Innovation and Formulation Advances

Innovations such as preservative-free formulations, sustained-release devices, and combination therapies have enhanced clinical efficacy and patient compliance. These innovations tend to command premium pricing, influencing overall revenue streams.

5. Reimbursement and Pricing Policies

Reimbursement frameworks influence patient access. In markets with robust insurance coverage, prescribing trends favor Travoprost due to its efficacy and tolerability. Conversely, price-sensitive markets see a shift towards lower-cost generics.

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Financial Trajectory Analysis

1. Revenue Trends

Recent financial reports indicate that Travoprost’s branded sales experienced stabilization and moderate growth in regions where patent exclusivity persists. However, global revenue growth is tempered by generic competition. For instance, Alcon's ophthalmic segment, which includes Travoprost, reported a marginal decline or stabilization contingent on regional patent statuses and formulary positioning.

2. Impact of Patent Expiry

The patent expiration trajectories of key formulations, notably in North America and Europe, catalyzed a transition from branded to generic sales. Data suggest that generic versions captured significant market share within 1-2 years of patent lapses, reducing per-unit prices and total revenue.

3. Regional Market Performance

• North America: Focused on branded formulations with strong adherence due to insurance coverage.
• Europe: Moderate patent expiry impact; growth fueled by the adoption of preservative-free formulations.
• Asia-Pacific: Rapid uptake of generics; pricing competition exerts pressure on revenues but offers volume-driven growth opportunities.

4. Future Revenue Forecasts

By 2028, the global ophthalmic glaucoma therapeutics market is projected to reach approximately USD 7 billion, with prostaglandin analogues representing nearly 60% of this figure [5]. The share specifically for Travoprost will hinge on patent timelines, regional approvals, and innovation adoption strategies. Analysts project a compound annual growth rate (CAGR) of around 3-4% for Travoprost-related revenues, factoring in brand-to-generic transition phases and emerging markets.

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Strategic Factors Influencing the Financial Trajectory

• Patent Strategies: Companies investing in patent extensions and formulations to delay generic entry will sustain higher revenue levels longer.
• Innovation Pipeline: Long-term growth relies on developing sustained-release devices and combination therapies enhancing efficacy and adherence.
• Market Penetration: Expanding access in developing countries remains crucial, with lower-cost generics and local manufacturing playing pivotal roles.
• Reimbursement Policies: Favorable policies will amplify sales, whereas restrictive measures might suppress growth potentials.

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Key Challenges and Risks

• Price Erosion: Patent expirations lead to commoditization, compressing margins.
• Generic Market Share: Rapid entry of generics diminishes profitability of branded travoprost.
• Regulatory Barriers: Slow approval processes for new formulations or region-specific regulations can delay revenue streams.
• Competitive Innovations: Emergence of new classes, such as Rho kinase inhibitors, may shift market share landscape.

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Conclusion

Travoprost’s market dynamics are characterized by a landscape in transformation, driven by patent cycles, regional disparities, and innovation. Its financial trajectory appears moderate, with growth opportunities primarily rooted in emerging markets and formulation enhancements. The balance between patent protection, generic competition, and innovation will determine revenue streams over the coming years. Stakeholders must adopt strategic positioning—embracing innovation, optimizing pricing, and expanding regional presence—to navigate the evolving ophthalmic therapeutics market successfully.

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Key Takeaways

• The global glaucoma market, fueled by rising prevalence, sustains consistent demand for prostaglandin analogues like Travoprost.
• Patent expirations have significantly introduced generics, impacting pricing and revenue, but also expanding access.
• Innovation in formulations (e.g., preservative-free, sustained-release) remains a key growth driver and differentiator.
• Regional market growth varies; developing regions present substantial volume opportunities despite pricing pressures.
• Strategic investment in R&D, patent management, and regional expansion are critical for maximizing Travoprost’s financial potential.

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FAQs

1. How does patent expiration impact Travoprost’s market share and revenue?
Patent expiration typically leads to a surge in generic entries, which increases market competition, reduces prices, and diminishes revenue for branded formulations. However, it also broadens access and volume sales, potentially offsetting some revenue declines.

2. Are there any recent innovations that could prolong Travoprost’s market viability?
Yes. Developments such as preservative-free formulations, sustained-release implants, and fixed-dose combinations aim to improve patient adherence and efficacy, supporting longer-term market relevance.

3. What regional factors most influence the financial outlook for Travoprost?
Regulatory approval processes, reimbursement policies, patent laws, and healthcare infrastructure significantly influence regional sales, with developed markets favoring branded products and emerging markets adopting generics rapidly.

4. How competitive is the landscape for Travoprost?
Highly competitive. Besides other prostaglandin analogues, fixed-dose combinations and novel drug classes challenge its market position. Pricing pressures from generics further intensify competition.

5. What strategic moves should manufacturers consider to optimize profits?
Investing in formulation innovations, extending patent life through formulations or delivery methods, expanding into underserved markets, and forging strategic partnerships can help sustain profitability amid generic competition.

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References

[1] Tham YC, et al. Global prevalence of glaucoma and projections for 2040. Lancet Glob Health. 2014;2(4):e11-8.
[2] Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006;90(3):262-7.
[3] Sato T, et al. Preservative-free prostaglandin analogs improve tolerability. J Ophthalmol. 2019;2019:Article ID 8149735.
[4] U.S. FDA. Generic drug approvals. 2021.
[5] Research and Markets. Global Ophthalmic Drugs Market Forecast. 2022.