IDOSE TR Drug Patent Profile

When do Idose Tr patents expire, and when can generic versions of Idose Tr launch?

Idose Tr is a drug marketed by Glaukos and is included in one NDA. There are two patents protecting this drug.

This drug has fifty-two patent family members in seven countries.

The generic ingredient in IDOSE TR is travoprost. There are fifteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the travoprost profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Idose Tr

A generic version of IDOSE TR was approved as travoprost by CHARTWELL RX on March 1^st, 2013.

Summary for IDOSE TR

International Patents:	52
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	4,008
Drug Prices:	Drug price information for IDOSE TR
What excipients (inactive ingredients) are in IDOSE TR?	IDOSE TR excipients list
DailyMed Link:	IDOSE TR at DailyMed

See drug prices for IDOSE TR

Pharmacology for IDOSE TR

Drug Class

Prostaglandin Analog

US Patents and Regulatory Information for IDOSE TR

IDOSE TR is protected by two US patents and one FDA Regulatory Exclusivity.

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
Glaukos	IDOSE TR	travoprost	IMPLANT;INTRACAMERAL	218010-001	Dec 13, 2023		RX	Yes	Yes			Y
Glaukos	IDOSE TR	travoprost	IMPLANT;INTRACAMERAL	218010-001	Dec 13, 2023		RX	Yes	Yes

EU/EMA Drug Approvals for IDOSE TR

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 IDOSE TR

See the table below for patents covering IDOSE TR around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2012071476
Japan	6714674
Japan	7507807
Australia	2021204100	Implants with controlled drug delivery features and methods of using same
World Intellectual Property Organization (WIPO)	2015073571

Supplementary Protection Certificates for IDOSE TR

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

IDOSE TR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for iDose® TR

Introduction to iDose® TR

iDose® TR, developed by Glaukos Corporation, is a groundbreaking intraocular implant designed to treat open-angle glaucoma and ocular hypertension. This innovative device uses Celanese's VitalDose® EVA technology to deliver travoprost, a prostaglandin analog, directly into the eye, providing a sustained release of the medication over an extended period.

FDA Approval and Clinical Trials

The FDA approval of iDose® TR in late 2023 was based on the results of two Phase 3 pivotal trials (GC-010 and GC-012) that compared the safety and efficacy of iDose® TR to topical timolol ophthalmic solution. These trials involved 1,150 subjects across 89 clinical sites and demonstrated that iDose® TR was non-inferior to timolol in reducing intraocular pressure (IOP) over the first three months, with a favorable tolerability and safety profile through 12 months[1][3].

Market Impact

The launch of iDose® TR is poised to disrupt the glaucoma treatment market by offering a more patient-friendly alternative to daily eye drops. This innovation addresses a significant unmet need, as patient non-compliance with topical medications is a common issue. The convenience and efficacy of iDose® TR could lead to increased demand, potentially giving Glaukos a competitive advantage in the market[4].

Patient Compliance and Outcomes

The Phase 2b trial highlighted that iDose® TR significantly reduced the burden of topical IOP-lowering medications. Over 90% of patients in the iDose® TR group had well-controlled IOP with the same or fewer medications at one year, and this control was maintained in 69% of patients at three years. This compares favorably to the timolol control group, where only 46% of subjects met the same benchmark[3].

Financial Implications

The introduction of iDose® TR is expected to contribute significantly to Glaukos's revenue growth. In 2023, Glaukos reported record net sales of $314.7 million, an 11% increase from 2022. The company anticipates further growth, with 2024 net sales projected to be in the range of $350 million to $360 million[5].

Pricing and Revenue Potential

iDose® TR has been priced at a wholesale acquisition cost of $13,950 per dose. Given its potential to replace or reduce the need for daily eye drops, this pricing could be attractive to both patients and healthcare providers, leading to substantial revenue generation for Glaukos[1].

Financial Health of Glaukos

Despite the promising revenue growth, Glaukos has incurred significant operating losses. For the nine months ended September 30, 2024, the company reported a net loss of $112.8 million on net sales of $278.0 million, resulting in a net profit margin of -40.6%. However, the company's liquidity position remains strong, with $100 million in cash and cash equivalents and $162 million in short-term investments as of September 30, 2024[2].

Potential for Future Growth

The success of iDose® TR could pave the way for future collaborations and applications in other therapeutic areas. The partnership with Celanese and the use of VitalDose® EVA technology may lead to new revenue streams from licensing or supply agreements, further enhancing the financial health of both companies[4].

Challenges and Considerations

While the financial outlook is promising, Glaukos must address ongoing net losses and monitor cash flow closely to ensure long-term sustainability. The company's accumulated deficit of $711.9 million could pose challenges in attracting future financing or investment if not managed effectively[2].

Competitive Landscape

The introduction of iDose® TR places Glaukos in a competitive position within the glaucoma treatment market. However, as sustained drug delivery systems gain traction, other companies may seek to develop similar technologies, potentially leading to increased competition in the future[4].

Patient and Market Adoption

The real-world performance of iDose® TR will be crucial in determining its long-term success. Monitoring adoption rates and patient feedback will be essential indicators of the product's impact on both Glaukos's financials and the broader market dynamics[4].

Conclusion

iDose® TR represents a significant advancement in glaucoma treatment, offering a more convenient and effective alternative to traditional eye drops. While Glaukos faces financial challenges, the market potential and revenue growth associated with iDose® TR position the company for future success. Close monitoring of cash flow, operational efficiency, and market adoption will be critical in ensuring the long-term viability of this innovative therapy.

Key Takeaways

• FDA Approval: iDose® TR received FDA approval in late 2023 based on Phase 3 trials showing non-inferiority to topical timolol.
• Market Impact: iDose® TR is expected to disrupt the glaucoma treatment market by addressing patient non-compliance issues.
• Financial Growth: The product is anticipated to contribute significantly to Glaukos's revenue growth.
• Pricing: iDose® TR is priced at $13,950 per dose, with potential for high revenue generation.
• Financial Health: Despite revenue growth, Glaukos faces ongoing net losses and must manage cash flow carefully.
• Future Potential: Success of iDose® TR could lead to new revenue streams and collaborations.

FAQs

Q: What is iDose® TR and how does it work? A: iDose® TR is an intraocular implant that delivers travoprost, a prostaglandin analog, directly into the eye using Celanese's VitalDose® EVA technology, providing sustained release of the medication.

Q: What were the key findings of the Phase 3 trials for iDose® TR? A: The Phase 3 trials showed that iDose® TR was non-inferior to topical timolol in reducing IOP over the first three months, with a favorable safety profile through 12 months.

Q: How much does iDose® TR cost? A: The wholesale acquisition cost of iDose® TR is $13,950 per dose.

Q: What are the financial implications of iDose® TR for Glaukos? A: iDose® TR is expected to contribute significantly to Glaukos's revenue growth, but the company must manage ongoing net losses to ensure long-term sustainability.

Q: What are the potential future applications of the VitalDose® EVA technology used in iDose® TR? A: The success of iDose® TR could lead to new revenue streams from licensing or supply agreements and applications in other therapeutic areas.

Sources

1. Glaukos Announces FDA Approval of iDose® TR (travoprost intracameral implant) - Glaukos Corporation.
2. Breaking Down Glaukos Corporation (GKOS) Financial Health: Key Metrics - DCF.
3. A Deep Dive on the iDose® TR Phase 2b Trial - Glaucoma Today.
4. Celanese Announces Commercial Launch of Glaukos' iDose® TR - Stock Titan.
5. Glaukos Announces Fourth Quarter and Full Year 2023 Financial Results - Glaukos Corporation.