TIMOLIDE 10-25 Drug Patent Profile

When do Timolide 10-25 patents expire, and when can generic versions of Timolide 10-25 launch?

Timolide 10-25 is a drug marketed by Merck and is included in one NDA.

The generic ingredient in TIMOLIDE 10-25 is hydrochlorothiazide; timolol maleate. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; timolol maleate profile page.

Summary for TIMOLIDE 10-25

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	TIMOLIDE 10-25 at DailyMed

US Patents and Regulatory Information for TIMOLIDE 10-25

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	TIMOLIDE 10-25	hydrochlorothiazide; timolol maleate	TABLET;ORAL	018061-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for TIMOLIDE 10-25

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	TIMOLIDE 10-25	hydrochlorothiazide; timolol maleate	TABLET;ORAL	018061-001	Approved Prior to Jan 1, 1982	3,655,663
Merck	TIMOLIDE 10-25	hydrochlorothiazide; timolol maleate	TABLET;ORAL	018061-001	Approved Prior to Jan 1, 1982	4,238,485

International Patents for TIMOLIDE 10-25

See the table below for patents covering TIMOLIDE 10-25 around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	954863
Yugoslavia	32950
Sweden	389102	MELLANPRODUKT TILL ANVENDNING FOR FRAMSTELLNING AV 1,2,5-TIADIAZOLFORENINGAR MED BETA-ADRENERGISKA BLOCKERINGSEGENSKAPER SAMT FORFARANDE FOR FRAMSTELLNING AV DENNA
United Kingdom	1264558
Yugoslavia	22278
Canada	949069	THIADIAZOLE PRODUCTS AND PROCESS
Austria	294830

Supplementary Protection Certificates for TIMOLIDE 10-25

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
0454511	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607

TIMOLIDE 10-25 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Timolide 10-25

Introduction

Timolide 10-25, a combination of timolol maleate and hydrochlorothiazide, is a widely used medication for the treatment of hypertension. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Overview

The market for antihypertensive drugs is vast and growing, driven by the increasing prevalence of hypertension globally. Timolide 10-25, as a combination therapy, benefits from the synergistic effects of a beta blocker (timolol maleate) and a diuretic (hydrochlorothiazide), making it an effective treatment option.

Competitive Landscape

The antihypertensive market is highly competitive, with numerous combination therapies available. Timolide 10-25 competes with other beta blocker and diuretic combinations such as Atenolol and chlorthalidone (Tenoretic), Bisoprolol and hydrochlorothiazide (Ziac), and Metoprolol and hydrochlorothiazide (Lopressor HCT)[1].

Patient Population and Demand

Hypertension affects a significant portion of the adult population, and the demand for effective antihypertensive medications is substantial. The patient population eligible for Timolide 10-25 includes those who require combination therapy to manage their blood pressure effectively.

Pricing and Cost Considerations

The cost of Timolide 10-25 can vary, but it is generally priced competitively within the market. For example, the cost of similar combination therapies like Bisoprolol and hydrochlorothiazide (Ziac) can range from $33 to $36 for a generic version[1]. The pricing strategy is crucial as it affects the drug's market share and profitability.

Side Effects and Safety Profile

The safety profile of Timolide 10-25 is an important factor influencing its market dynamics. Common side effects include dizziness, headache, and increased cough, similar to other combination therapies. The drug is generally well-tolerated, with adverse metabolic effects more commonly associated with higher doses of hydrochlorothiazide[1].

Regulatory Environment

Regulatory approvals and post-marketing surveillance play a significant role in the market trajectory of any drug. For Timolide 10-25, regulatory bodies have approved its use based on clinical trials demonstrating its efficacy and safety. There are no specific post-marketing actions or phase 4 commitments required for this drug[4].

Financial Performance and Projections

The financial performance of Timolide 10-25 is tied to the overall sales of antihypertensive medications. The market for hypertension treatments is expected to grow, driven by increasing prevalence and the need for effective management options.

Sales and Revenue

The sales of Timolide 10-25 contribute to the broader revenue streams of pharmaceutical companies. For instance, companies like Eli Lilly, which have a strong presence in the diabetes and obesity markets, also benefit from their antihypertensive portfolios. The revenue from these drugs can be substantial, with estimates suggesting that the U.S. market alone for certain antihypertensive and related treatments could reach $100 billion to $150 billion annually[3].

Expenses and Profitability

The profitability of Timolide 10-25 is influenced by various factors, including research and development (R&D) expenses, sales and general administrative (SG&A) expenses, and the impact of foreign exchange rates. Companies may experience fluctuations in profitability due to these factors. For example, Santen Pharmaceutical noted an increase in SG&A and R&D expenses, which affected their operating profit despite growing sales[2].

Market Growth and Future Prospects

The market for antihypertensive drugs, including Timolide 10-25, is expected to grow due to several factors:

Increasing Prevalence of Hypertension

The global prevalence of hypertension is increasing, driven by demographic changes and lifestyle factors. This trend is expected to continue, driving demand for effective antihypertensive medications.

Advancements in Treatment Options

Continuous advancements in pharmaceutical research and development are likely to introduce new and improved treatment options. However, combination therapies like Timolide 10-25 remain a cornerstone in hypertension management due to their proven efficacy.

Economic Factors

The economic environment, including healthcare policies and reimbursement strategies, can significantly impact the market dynamics of antihypertensive drugs. Negotiated discounts and rebates can affect the net pricing of these medications, making them more accessible to a wider patient population[3].

Key Takeaways

• Competitive Market: Timolide 10-25 operates in a highly competitive antihypertensive market with numerous combination therapies.
• Pricing and Cost: The drug is priced competitively, with costs varying based on generic versions and market conditions.
• Safety Profile: Generally well-tolerated, with common side effects similar to other combination therapies.
• Regulatory Compliance: Approved with no specific post-marketing actions required.
• Financial Performance: Contributes to the broader revenue streams of pharmaceutical companies, influenced by R&D, SG&A expenses, and foreign exchange rates.
• Future Prospects: Expected to grow due to increasing prevalence of hypertension, advancements in treatment options, and economic factors.

FAQs

Q: What are the common side effects of Timolide 10-25?

A: Common side effects include dizziness, headache, and increased cough, with adverse metabolic effects more commonly associated with higher doses of hydrochlorothiazide[1].

Q: How does Timolide 10-25 compare to other antihypertensive combination therapies?

A: Timolide 10-25 competes with other beta blocker and diuretic combinations and is generally priced competitively within the market[1].

Q: What are the regulatory requirements for Timolide 10-25?

A: The drug has been approved with no specific post-marketing actions or phase 4 commitments required[4].

Q: How does the financial performance of Timolide 10-25 impact pharmaceutical companies?

A: The sales of Timolide 10-25 contribute to the broader revenue streams of pharmaceutical companies, influenced by R&D, SG&A expenses, and foreign exchange rates[2].

Q: What are the future prospects for the market of Timolide 10-25?

A: The market is expected to grow due to increasing prevalence of hypertension, advancements in treatment options, and economic factors[3].

Cited Sources

1. American Academy of Family Physicians - Combination Antihypertensive Drugs: Recommendations for Use[1].
2. Santen Pharmaceutical - Q3 FY2021 Financial Results[2].
3. Baron Capital Group - A Multi-Billion-Dollar Drug Market[3].
4. FDA - Timolol Clinical BPCA[4].