MONOPRIL-HCT Drug Patent Profile

Which patents cover Monopril-hct, and when can generic versions of Monopril-hct launch?

Monopril-hct is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in MONOPRIL-HCT is fosinopril sodium; hydrochlorothiazide. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Monopril-hct

A generic version of MONOPRIL-HCT was approved as fosinopril sodium; hydrochlorothiazide by SANDOZ on September 28^th, 2005.

Summary for MONOPRIL-HCT

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	5
DailyMed Link:	MONOPRIL-HCT at DailyMed

Recent Clinical Trials for MONOPRIL-HCT

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

Sponsor	Phase
University of Nebraska	Phase 4
Ranbaxy Laboratories Limited	N/A

See all MONOPRIL-HCT clinical trials

US Patents and Regulatory Information for MONOPRIL-HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994		DISCN	Yes	No
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994		DISCN	Yes	No

Expired US Patents for MONOPRIL-HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994	4,384,123
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994	4,337,201*PED
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994	5,006,344*PED
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994	4,337,201*PED
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994	5,006,344*PED
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994	4,384,123

International Patents for MONOPRIL-HCT

See the table below for patents covering MONOPRIL-HCT around the world.

Country	Patent Number	Title	Estimated Expiration
Ireland	51876	PHOSPHINYLALKANOYL SUTSTITUTED PROLINES
Denmark	0408273
Japan	2965633
Hungary	187381	PROCESS FOR PRODUCING PHOSPHYNIL-ALKANOYL-SUBSTITUTED PROLINE DERIVATIVES
Canada	1169073	PROLINES A SUBSTITUTION PAR DES PHOSPHINYLALCANOYLES (PHOSPHINYLALKANOYL SUBSTITUTED PROLINES)
Luxembourg	88295

Supplementary Protection Certificates for MONOPRIL-HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0053902	SPC/GB93/028	United Kingdom		SPC/GB93/028, EXPIRES: 20050702
0053902	96C0036	Belgium		PRODUCT NAME: FAMCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21325 19960708; FIRST REGISTRATION: GB - 10592/0035 19931210
0053902	SPC/GB96/024	United Kingdom		SPC/GB96/024:, EXPIRES: 20061126

MONOPRIL-HCT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MONOPRIL-HCT

Introduction

MONOPRIL-HCT, a combination of fosinopril sodium and hydrochlorothiazide, is a medication used to treat hypertension. Understanding its market dynamics and financial trajectory involves examining several key factors, including its efficacy, side effects, market competition, and the impact of generic entries.

Efficacy and Clinical Use

MONOPRIL-HCT is indicated for the treatment of hypertension and is available in two tablet strengths: 10/12.5 mg and 20/12.5 mg of fosinopril sodium and hydrochlorothiazide, respectively[1][5].

• Clinical Benefits: The combination of an ACE inhibitor (fosinopril) and a thiazide diuretic (hydrochlorothiazide) provides a synergistic effect in lowering blood pressure and relieving symptoms of fluid retention. This fixed-dose combination (FDC) is particularly beneficial as it increases medication adherence and persistence, reduces clinical inertia, and decreases the time to achieve blood pressure control[4].

Side Effects and Safety Profile

While MONOPRIL-HCT has been evaluated for safety in over 660 patients and is generally well-tolerated, it does come with potential side effects.

• Common Side Effects: Headache, cough, fatigue, dizziness, and upper respiratory infections are among the most common side effects reported[1][5].
• Serious Side Effects: These include signs of allergic reactions, high or low potassium levels, low sodium levels, and severe skin reactions. The risk of agranulocytosis and angioedema, particularly in certain patient groups, is also a consideration[1][5].

Market Competition

The hypertension market is highly competitive, with numerous antihypertensive medications available.

• Fixed-Dose Combinations: There are 29 FDA-approved FDCs for hypertension in the U.S., each with varying levels of coverage by Medicaid and other health insurance programs. This competition can affect the market share of MONOPRIL-HCT[4].

Generic Entries and Their Impact

Generic entries have significantly impacted the financial trajectory of branded hypertension medications, including MONOPRIL-HCT.

• Generic Equivalents: Although the MONOPRIL-HCT brand has been discontinued in the U.S., generic versions of this product are available. This transition to generic equivalents typically reduces the revenue for the original brand[5].
• Consumer Welfare: Studies have shown that early generic entry, facilitated by Paragraph IV certifications, results in substantial consumer welfare gains. For the hypertension market, this translated to approximately $92 billion in consumer savings between 1997 and 2008[3].

Financial Trajectory

The financial performance of MONOPRIL-HCT has been influenced by several factors:

• Revenue Decline: The discontinuation of the brand name and the availability of generic equivalents have likely led to a decline in revenue for MONOPRIL-HCT. Generic competition often reduces the market share and pricing power of the original branded product[5].
• Cost Savings: From a healthcare system perspective, the use of FDCs like MONOPRIL-HCT can lead to cost savings due to improved adherence and reduced need for multiple prescriptions. However, this does not directly benefit the manufacturer of the branded product[4].

Impact of Regulatory Changes

Regulatory changes and guidelines also play a crucial role in the market dynamics of antihypertensive medications.

• Guideline Recommendations: The 2017 American Heart Association/American College of Cardiology blood pressure guidelines recommend initial combination therapy for most people with hypertension. This can increase the demand for FDCs like MONOPRIL-HCT, but the benefit is more likely to be seen in the generic market[4].

Cross-Molecular Substitution

The hypertension market experiences significant cross-molecular substitution, where patients switch from one branded product to the generic of another branded product. This phenomenon further complicates the financial trajectory of branded medications like MONOPRIL-HCT[3].

Conclusion

MONOPRIL-HCT, as a fixed-dose combination antihypertensive medication, has a complex market and financial trajectory. While it offers clinical benefits and improves patient adherence, its financial performance is heavily influenced by generic competition, regulatory changes, and market dynamics.

Key Takeaways

• Efficacy and Safety: MONOPRIL-HCT is effective in treating hypertension but comes with potential side effects.
• Market Competition: The hypertension market is highly competitive, with numerous FDCs available.
• Generic Entries: Generic equivalents have significantly reduced the revenue for the branded product.
• Financial Impact: The financial trajectory of MONOPRIL-HCT has declined due to generic competition and regulatory changes.
• Regulatory Changes: Guidelines recommending combination therapy can increase demand for FDCs but benefit the generic market more.

FAQs

Q: What is MONOPRIL-HCT used for? A: MONOPRIL-HCT is used to treat hypertension (high blood pressure).

Q: What are the common side effects of MONOPRIL-HCT? A: Common side effects include headache, cough, fatigue, dizziness, and upper respiratory infections.

Q: Why has the revenue for MONOPRIL-HCT likely declined? A: The revenue has likely declined due to the discontinuation of the brand name and the availability of generic equivalents.

Q: How do regulatory changes impact the market for MONOPRIL-HCT? A: Regulatory changes, such as guidelines recommending combination therapy, can increase demand for FDCs but primarily benefit the generic market.

Q: What is the impact of cross-molecular substitution on MONOPRIL-HCT? A: Cross-molecular substitution, where patients switch to generics of other branded products, further complicates the financial trajectory of MONOPRIL-HCT.

Sources

1. RxList: Monopril HCT (Fosinopril Sodium-Hydrochlorothiazide Tablets)
2. CDC: 2016 NHAMCS Micro-Data File Documentation
3. NBER: Regulation and Welfare: Evidence from Paragraph IV Generic Entry
4. Million Hearts: Fixed-Dose Combination Antihypertensive Medication Coverage by State Medicaid Programs
5. Drugs.com: Monopril HCT Uses, Side Effects & Warnings