MODURETIC 5-50 Drug Patent Profile

Which patents cover Moduretic 5-50, and what generic alternatives are available?

Moduretic 5-50 is a drug marketed by Merck and is included in one NDA.

The generic ingredient in MODURETIC 5-50 is amiloride hydrochloride; hydrochlorothiazide. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amiloride hydrochloride; hydrochlorothiazide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Moduretic 5-50

A generic version of MODURETIC 5-50 was approved as amiloride hydrochloride; hydrochlorothiazide by BARR on May 10^th, 1988.

Summary for MODURETIC 5-50

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	2
Patent Applications:	114
DailyMed Link:	MODURETIC 5-50 at DailyMed

Recent Clinical Trials for MODURETIC 5-50

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
Centre Hospitalier Universitaire de Saint Etienne	Phase 4

See all MODURETIC 5-50 clinical trials

US Patents and Regulatory Information for MODURETIC 5-50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	MODURETIC 5-50	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	018201-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for MODURETIC 5-50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	MODURETIC 5-50	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	018201-001	Approved Prior to Jan 1, 1982

International Patents for MODURETIC 5-50

See the table below for patents covering MODURETIC 5-50 around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	1087875
Switzerland	457437	Verfahren zur Herstellung von 3-Indolyl-niederaliphatischen Säuren
Norway	122247
Finland	47098
Denmark	112239
Norway	124641

MODURETIC 5-50 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MODURETIC 5-50

Introduction to MODURETIC 5-50

MODURETIC 5-50, a combination drug consisting of amiloride and hydrochlorothiazide, is used to treat high blood pressure (hypertension) and fluid retention (edema) in various conditions, including cardiac origin and hepatic cirrhosis with ascites[2][4][5].

Market Position and Indications

MODURETIC 5-50 is positioned as a secondary treatment option for hypertension and edema, particularly in cases where potassium depletion is a concern. It is not indicated for initial therapy of edema or hypertension unless the risk of hypokalemia cannot be tolerated[1][4].

Competitive Landscape

The market for antihypertensive and diuretic medications is highly competitive, with numerous branded and generic options available. MODURETIC 5-50 competes with other potassium-sparing diuretics and thiazide combinations. However, its unique combination of amiloride and hydrochlorothiazide provides a specific advantage in maintaining potassium balance, which can be a differentiator in certain patient populations[2][4].

Regulatory Status

The brand name MODURETIC 5-50 has been discontinued in the U.S., but generic versions of this product may still be available if approved by the FDA. This change can impact the drug's market dynamics, as generic alternatives often reduce the market share and revenue of the original branded product[2][4].

Usage and Dosage

The drug is administered orally, typically starting with one tablet a day, which can be increased to two tablets if necessary. The dosage should not exceed four tablets per day. This dosage flexibility can influence prescribing patterns and patient compliance, affecting the drug's market performance[1][5].

Side Effects and Safety Profile

MODURETIC 5-50 has a generally well-tolerated safety profile, but it can cause significant side effects such as hyperkalemia, especially in patients with renal impairment or diabetes mellitus. Monitoring serum potassium levels is crucial, which may impact the drug's usage and market acceptance[1][2][4].

Financial Performance

Revenue Trends

The financial trajectory of MODURETIC 5-50 has likely been impacted by its discontinuation as a branded product. Generic competition typically leads to a decline in revenue for the original product. However, the continued availability of generic versions can maintain some level of market presence and revenue, albeit at a lower margin.

Cost and Pricing

The cost of MODURETIC 5-50, especially in its generic form, is generally lower compared to other antihypertensive medications. This pricing strategy can make it more accessible to a broader patient population, influencing its market share and financial performance.

Market Share

Given the competitive nature of the antihypertensive market and the availability of alternative treatments, MODURETIC 5-50's market share has likely decreased since its brand discontinuation. However, its unique formulation and the continued need for potassium-sparing diuretics ensure it retains a niche market presence.

Impact of Generic Competition

The introduction of generic versions of MODURETIC 5-50 has significantly altered its financial trajectory. Generic drugs typically capture a substantial portion of the market share due to their lower prices, leading to reduced revenue for the original branded product. This shift has likely resulted in a decline in the drug's overall revenue and profitability.

Patient and Prescriber Preferences

Patient and prescriber preferences play a crucial role in the market dynamics of MODURETIC 5-50. The drug's ability to maintain potassium balance is a key selling point, especially for patients at risk of hypokalemia. However, the availability of other treatment options and the influence of formulary decisions can affect prescribing patterns and patient adherence.

Regulatory and Healthcare Policy Impact

Regulatory changes and healthcare policies can significantly impact the financial trajectory of MODURETIC 5-50. For instance, formulary inclusion and reimbursement policies can influence the drug's accessibility and affordability, thereby affecting its market performance.

Future Outlook

The future outlook for MODURETIC 5-50 is likely to be stable but modest. While it will continue to serve a niche market due to its unique formulation, the presence of generic competition and other antihypertensive treatments will limit its growth potential. Continuous monitoring of side effects, especially hyperkalemia, and adherence to dosage guidelines will remain critical for maintaining patient safety and market trust.

Key Takeaways

• Market Position: MODURETIC 5-50 is a secondary treatment option for hypertension and edema, particularly where potassium balance is crucial.
• Regulatory Status: The brand name has been discontinued, but generic versions may still be available.
• Financial Performance: Revenue has likely declined due to generic competition.
• Safety Profile: Monitoring for hyperkalemia is essential, especially in patients with renal impairment or diabetes.
• Future Outlook: Stable but modest, with a niche market presence due to its unique formulation.

FAQs

Q: What is MODURETIC 5-50 used for?

A: MODURETIC 5-50 is used to treat high blood pressure (hypertension) and fluid retention (edema) in conditions such as cardiac origin and hepatic cirrhosis with ascites.

Q: Why has the brand name MODURETIC 5-50 been discontinued?

A: The brand name MODURETIC 5-50 has been discontinued in the U.S., but generic versions may still be available if approved by the FDA.

Q: What are the potential side effects of MODURETIC 5-50?

A: MODURETIC 5-50 can cause significant side effects such as hyperkalemia, especially in patients with renal impairment or diabetes mellitus. Other side effects include nausea, abdominal pain, and mild skin rash.

Q: How does MODURETIC 5-50 differ from other antihypertensive medications?

A: MODURETIC 5-50 combines a potassium-sparing diuretic (amiloride) with a thiazide diuretic (hydrochlorothiazide), which helps maintain potassium balance, a unique advantage in certain patient populations.

Q: What is the typical dosage of MODURETIC 5-50?

A: The typical dosage is one to two tablets per day, not exceeding four tablets per day, depending on the patient's response and serum potassium levels.

Cited Sources

1. RxList: Moduretic (Amiloride and Hydrochlorothiazide): Side Effects, Uses ...
2. Drugs.com: Moduretic 5-50 Advanced Patient Information
3. AHAJournals: Seventh Report of the Joint National Committee on Prevention ...
4. Drugs.com: Moduretic 5-50 Uses, Side Effects & Warnings
5. Medsafe: New Zealand Data Sheet - MODURETIC 50mg/5mg Tablet