ISTALOL Drug Patent Profile

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

Istalol is a drug marketed by Bausch And Lomb and is included in one NDA.

The generic ingredient in ISTALOL is timolol maleate. There are fifteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Istalol

A generic version of ISTALOL was approved as timolol maleate by MYLAN on June 8^th, 1990.

Summary for ISTALOL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	1
Patent Applications:	4,462
Drug Prices:	Drug price information for ISTALOL
What excipients (inactive ingredients) are in ISTALOL?	ISTALOL excipients list
DailyMed Link:	ISTALOL at DailyMed

See drug prices for ISTALOL

See drug sales revenues for ISTALOL

Recent Clinical Trials for ISTALOL

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

Sponsor	Phase
Bp Consulting, Inc	Phase 4

See all ISTALOL clinical trials

Pharmacology for ISTALOL

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Paragraph IV (Patent) Challenges for ISTALOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ISTALOL	Ophthalmic Solution	timolol maleate	0.5%	021516	1	2012-10-19

US Patents and Regulatory Information for ISTALOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb	ISTALOL	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021516-001	Jun 4, 2004	AT2	RX	Yes	Yes

Expired US Patents for ISTALOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	ISTALOL	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021516-001	Jun 4, 2004	6,335,335
Bausch And Lomb	ISTALOL	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021516-001	Jun 4, 2004	6,645,963

International Patents for ISTALOL

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

Country	Patent Number	Title	Estimated Expiration
China	1278162
Germany	69839152
Canada	2307303	COLLYRES A LIBERATION PROLONGEE (PROLONGED-ACTION EYE DROP)

Supplementary Protection Certificates for ISTALOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0509752	2000C/001	Belgium		PRODUCT NAME: DORZOLAMIDI HYDROCHLORIDUM EQ. DORZOLAMIDUM, TIMOLOLI MALEAS EQ. TIMOLOLUM; NAT. REGISTRATION NO/DATE: 922 IS 180 F 13 19981110; FIRST REGISTRATION: DK 19045 19980306
0509752	49/1999	Austria		PRODUCT NAME: DORZOLAMID ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE DORZOLAMIDHYDROCHLORID, UND TIMOLOL ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE TIMOLOLMALEAT; NAT. REGISTRATION NO/DATE: 1-22701, 1-22702 19980828; FIRST REGISTRATION: DK 9794 19980306
0227494	95C0013	Belgium		PRODUCT NAME: TIMOLOLI MALEAS EQ. TIMOLOLUM; NATIONAL REGISTRATION/DATE: 922 IS 166 F 13 19950627; FIRST REGISTRATION: SE 11901 19930910

ISTALOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ISTALOL

Introduction

ISTALOL, a timolol maleate ophthalmic solution, is a non-selective beta-adrenergic receptor blocking agent used in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Here, we delve into the market dynamics and financial trajectory of ISTALOL, exploring its indications, market performance, and the financial strategies of its parent company.

Indications and Usage

ISTALOL is specifically indicated for reducing elevated intraocular pressure, a major risk factor in the pathogenesis of glaucomatous visual field loss and optic nerve damage. It works by reducing aqueous formation and, in some cases, slightly increasing outflow facility[1].

Market Position

ISTALOL is part of the ophthalmic pharmaceutical market, which is a significant segment within the healthcare industry. The U.S. prescription ophthalmic industry, in particular, is valued at approximately $3.2 billion and includes therapies for various ocular conditions such as glaucoma, inflammation, ocular pain, allergy, and dry eye[3].

Competition

The glaucoma pharmacotherapy market is relatively stable with a few key players. Since the approval of timolol in 1978, there have been several advancements, including the introduction of prostaglandin analogues like latanoprost. However, the number of new pharmacotherapies for glaucoma has been limited due to regulatory and financial challenges. ISTALOL competes with other beta-adrenergic antagonists and combination therapies like dorzolamide-timolol and brimonidine-timolol[4].

Financial Performance

ISTALOL is one of the key products of ISTA Pharmaceuticals, which was later acquired by Bausch + Lomb, a subsidiary of Bausch Health Companies Inc.

Revenue Contribution

In the third quarter of 2007, ISTALOL contributed $2.5 million to ISTA Pharmaceuticals' net revenue, representing a 32% increase from the previous year. This growth was part of the company's overall success, with net revenue increasing by 92% during the same period[3].

Parent Company's Financial Strategies

Bausch Health Companies Inc. has been actively managing its capital structure to improve liquidity and reduce leverage. Key strategies include:

• Debt Repayment and Refinancing: The company has repaid significant amounts of debt using proceeds from the Bausch + Lomb (B+L) IPO, open market repurchases, and refinancing. This has reduced the aggregate principal amount of debt obligations substantially[2][5].
• Exchange Offers: Bausch Health Companies Inc. completed an exchange offer that reduced the outstanding principal balance of its debt by $2,469 million, exchanging existing unsecured senior notes for newly issued secured notes[2][5].
• Capital Structure Improvement: These transactions have improved the company's overall capitalization and leverage, providing additional flexibility in terms of liquidity and operational management[2][5].

Market Impact and Growth

The success of ISTALOL and other ophthalmic products has been crucial for the growth of ISTA Pharmaceuticals and subsequently Bausch + Lomb.

Commercial Success

ISTA Pharmaceuticals aimed to launch a new product every 12 to 18 months to continue its growth and become a leading niche ophthalmic pharmaceutical company in the U.S. ISTALOL's safety profile and efficacy made it an ideal product for combination treatment, contributing to its commercial success[3].

Regulatory Environment

The regulatory environment, particularly the FDA's approval process, plays a significant role in the development and market entry of new ophthalmic drugs. The relative paucity of new glaucoma pharmacotherapies is partly due to the challenges in demonstrating efficacy compared to established agents like timolol and latanoprost[4].

Financial Opportunities and Challenges

The financial viability of developing new ophthalmic drugs, including those for glaucoma, is a critical factor.

Financial Viability

For private sector investment in drug development, there must be a potential for profit. The expiration of patents on key glaucoma medications, such as prostaglandin analogues, has led to increased competition from generic alternatives, affecting the financial incentives for developing new therapies[4].

Cost and Revenue Dynamics

The cost of developing and bringing a new drug to market is high, and the return on investment is often uncertain. ISTALOL's continued market presence and revenue contribution are testament to its enduring value in the treatment of glaucoma, despite the challenges in the broader market[3].

Key Takeaways

• Market Position: ISTALOL is a significant player in the glaucoma pharmacotherapy market, with a long history of efficacy in reducing intraocular pressure.
• Financial Performance: The drug has contributed to the revenue growth of its parent companies, including ISTA Pharmaceuticals and Bausch Health Companies Inc.
• Regulatory and Financial Challenges: The development of new glaucoma therapies faces regulatory and financial hurdles, impacting the pace of innovation in this field.
• Parent Company Strategies: Bausch Health Companies Inc. has implemented various financial strategies to improve its capital structure and reduce debt, enhancing its operational flexibility.

FAQs

What is ISTALOL used for?

ISTALOL is used to treat elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

How does ISTALOL work?

ISTALOL works by reducing aqueous formation and, in some cases, slightly increasing outflow facility to lower intraocular pressure.

What company produces ISTALOL?

ISTALOL is produced by Bausch + Lomb, a subsidiary of Bausch Health Companies Inc.

What are the common side effects of ISTALOL?

The most frequently reported adverse reactions to ISTALOL include burning and stinging upon instillation, affecting about 38% of patients[1].

How has the financial performance of ISTALOL impacted its parent company?

ISTALOL has contributed to the revenue growth of its parent companies, helping to support their financial health and strategic initiatives.

Sources

1. Medthority: ISTALOL TIMOLOL MALEATE 5 mg/mL Bausch & Lomb Incorporated.
2. Marketscreener: BAUSCH HEALTH COMPANIES INC. Management's Discussion and Analysis of Financial Condition and Results of Operations.
3. ISTA Pharmaceuticals: ISTA Q3 07 Fact Sheet.
4. Glaucoma Today: Why Are There Not More Pharmacotherapies for Glaucoma?
5. Marketscreener: BAUSCH HEALTH COMPANIES INC. Management's Discussion and Analysis of Financial Condition and Results of Operations.