Travoprost - Generic Drug Details

What are the generic 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 Pharma Ltd, Lupin Ltd, Micro Labs, Mylan, and Somerset Theraps Llc, and is included in twelve NDAs. There are nine 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-six 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:	136
US Patents:	9
Tradenames:	5
Applicants:	12
NDAs:	12
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	105
Patent Applications:	5,857
Drug Prices:	Drug price trends for travoprost
Drug Sales Revenues:	Drug sales revenues 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
Assiut University	Phase 4
Glaukos Corporation	Phase 3

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
Gland Pharma Ltd	TRAVOPROST	travoprost	SOLUTION/DROPS;OPHTHALMIC	218159-001	Jul 12, 2024	AT	RX	No	No
Chartwell Rx	TRAVOPROST	travoprost	SOLUTION/DROPS;OPHTHALMIC	091340-001	Mar 1, 2013	AT1	RX	No	Yes
Novartis	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No			Y
Apotex	TRAVOPROST	travoprost	SOLUTION/DROPS;OPHTHALMIC	203431-001	Jul 10, 2015	AT	RX	No	No
Mylan	TRAVOPROST	travoprost	SOLUTION/DROPS;OPHTHALMIC	205050-001	Jul 7, 2017	AT	RX	No	No
Novartis	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No			Y
Glaukos	IDOSE TR	travoprost	IMPLANT;INTRACAMERAL	218010-001	Dec 13, 2023		RX	Yes	Yes			Y

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/002738 Decrease 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/000390 Decrease 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
Hong Kong	1126667	SELF PRESERVED AQUEOUS PHARMACEUTICAL COMPOSITIONS
Spain	2637028
World Intellectual Property Organization (WIPO)	2012071476
Japan	6714674
Uruguay	30605	COMPOSICIONES FARMACÉUTICAS ACUOSAS AUTOCONSERVADAS
Japan	7507807
Denmark	3042646

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
1920764	C01920764/01	Switzerland		PRODUCT NAME: TRAVOPROST; REGISTRATION NUMBER/DATE: SWISSMEDIC 55910 22.05.2002
1514548	C300671	Netherlands		PRODUCT NAME: TRAVOPROST; REGISTRATION NO/DATE: EG EU/1/01/199/001-002 20011128
1920764	SPC/GB12/038	United Kingdom		PRODUCT NAME: TRAVOPROST; REGISTERED: UK EU/1/01/199/001-002 20011129
1920764	12C0045	France		PRODUCT NAME: TRAVOPROST; REGISTRATION NO/DATE: EU/1/01/199/001 20011127
1514548	CA 2014 00038	Denmark		PRODUCT NAME: TRAVOPROST; REG. NO/DATE: EU/1/01/199/001-002 20011127
1920764	1290027-0	Sweden		PRODUCT NAME: TRAVOPROST

Travoprost Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Travoprost

Introduction to Travoprost

Travoprost is a prostaglandin analog used primarily in the treatment of elevated intraocular pressure due to open-angle glaucoma or ocular hypertension. It is known for its high efficacy and selectivity in reducing intraocular pressure, making it a significant player in the ophthalmic pharmaceutical market.

Market Size and Growth

The global travoprost market is experiencing substantial growth. As of 2023, the market size was valued at approximately USD 1.2 billion and is projected to reach USD 2.3 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 7.5% during this period[4].

Driving Factors Behind Market Growth

Several factors are driving the growth of the travoprost market:

Increasing Prevalence of Glaucoma

Glaucoma is a progressive condition that affects a significant portion of the global population, particularly in older age groups. The increasing prevalence of glaucoma and ocular hypertension is a major driver for the demand of travoprost and other glaucoma medications.

FDA Approvals and New Technologies

The recent FDA approval of Glaukos’ iDose TR (travoprost intracameral implant) is a significant milestone. This implantable device provides a long-duration therapy, delivering a preservative-free formulation of travoprost continuously for up to three years. This innovation addresses the compliance issues associated with topical medications, where 50% of patients are noncompliant and another 35% administer the medication improperly[2].

Financial Assistance and Access Programs

To make travoprost more accessible, various financial aid resources and patient assistance programs are available. Pharmaceutical companies and organizations offer discounts, copay assistance, and patient assistance programs to help cover the costs of glaucoma medications, including travoprost[5].

Financial Trajectory

Current Market Valuation

The travoprost market is valued at USD 1.2 billion as of 2023 and is expected to more than double by 2032, reaching USD 2.3 billion. This growth is driven by increasing demand, advancements in technology, and expanding access to treatment options[4].

Pricing and Cost Considerations

The wholesale acquisition cost of the newly approved iDose TR implant is $13,950 per dose/implant. While this is a significant cost, the long-term benefits and reduced need for frequent topical medication administration can make it a cost-effective option in the long run. Additionally, Glaukos is providing copay and financial assistance for qualifying patients, which helps in making the treatment more affordable[2].

Revenue Projections

Given the CAGR of 7.5%, the travoprost market is expected to see steady and significant revenue growth over the next decade. This growth will be fueled by the increasing adoption of innovative treatments like iDose TR and the expanding patient base due to the rising prevalence of glaucoma and ocular hypertension.

Competitive Landscape

The ophthalmic pharmaceutical market is competitive, with several other prostaglandin analogs and combination therapies available. However, travoprost stands out due to its high selectivity and efficacy. The introduction of the iDose TR implant further differentiates travoprost in the market, offering a unique solution to the compliance challenges associated with traditional topical treatments[2][3].

Regulatory Environment

The FDA approval of iDose TR is a critical factor in the market dynamics of travoprost. The approval was based on results from two phase 3 pivotal trials that demonstrated the safety and efficacy of the implant. While the trials showed non-inferiority to topical timolol ophthalmic solution in the first three months, further studies are needed to assess long-term efficacy and the potential for repeat administrations[2].

Patient Compliance and Adherence

Patient compliance is a significant challenge in glaucoma treatment. The iDose TR implant addresses this issue by providing a continuous delivery of travoprost for up to three years, reducing the need for daily medication administration. This can lead to better disease management and improved patient outcomes[2].

Future Outlook

The future outlook for the travoprost market is promising. With ongoing research and development, particularly in the area of implantable devices, the market is expected to continue growing. The focus on improving patient compliance and reducing the burden of topical medications will drive innovation and adoption of travoprost-based treatments.

Key Takeaways

• Market Growth: The global travoprost market is projected to grow from USD 1.2 billion in 2023 to USD 2.3 billion by 2032.
• Innovative Treatments: The FDA approval of iDose TR (travoprost intracameral implant) marks a significant advancement in glaucoma treatment.
• Financial Assistance: Various programs are available to help patients cover the costs of travoprost and other glaucoma medications.
• Compliance: The iDose TR implant improves patient compliance by providing continuous delivery of travoprost for up to three years.
• Regulatory Environment: Ongoing regulatory approvals and trials will continue to shape the market dynamics of travoprost.

FAQs

What is travoprost used for?

Travoprost is used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension[3].

How does the iDose TR implant work?

The iDose TR implant delivers a preservative-free formulation of travoprost continuously for up to three years, reducing the need for daily topical medication administration[2].

What is the cost of the iDose TR implant?

The wholesale acquisition cost of the iDose TR implant is $13,950 per dose/implant[2].

Are there financial assistance programs available for travoprost?

Yes, various financial aid resources and patient assistance programs are available to help cover the costs of glaucoma medications, including travoprost[5].

What are the common side effects of travoprost?

Common side effects include increases in intraocular pressure, iritis, dry eye, and visual field defects, most of which are mild and transient[2].

Sources

1. Market Research Intellect - Travoprost Market Size And Projection.
2. Managed Healthcare Executive - FDA Approves Implantable Glaucoma Treatment.
3. DrugBank Online - Travoprost: Uses, Interactions, Mechanism of Action.
4. Dataintelo - Travoprost Market Research Report 2032.
5. BrightFocus Foundation - Financial Aid for Glaucoma Medications.