INSPRA Drug Patent Profile

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

Inspra is a drug marketed by Upjohn and is included in one NDA.

The generic ingredient in INSPRA is eplerenone. There are five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the eplerenone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Inspra

A generic version of INSPRA was approved as eplerenone by CHARTWELL RX on July 30^th, 2008.

Summary for INSPRA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	33
Patent Applications:	3,605
Drug Prices:	Drug price information for INSPRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INSPRA
What excipients (inactive ingredients) are in INSPRA?	INSPRA excipients list
DailyMed Link:	INSPRA at DailyMed

See drug prices for INSPRA

Recent Clinical Trials for INSPRA

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

Sponsor	Phase
ACDIMA Biocenter	Phase 1
Darnitsa Pharmaceutical Company	Phase 1
University of Cincinnati	Phase 4

See all INSPRA clinical trials

Pharmacology for INSPRA

Drug Class	Aldosterone Antagonist
Mechanism of Action	Aldosterone Antagonists

Paragraph IV (Patent) Challenges for INSPRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INSPRA	Injection	eplerenone	0.75 mg/mL, 100 mL vial	021437	1	2009-06-05
INSPRA	Tablets	eplerenone	25 mg and 50 mg	021437	2	2006-09-27

US Patents and Regulatory Information for INSPRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-001	Sep 27, 2002	AB	RX	Yes	No
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-002	Sep 27, 2002	AB	RX	Yes	Yes
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-003	Sep 27, 2002		DISCN	No	No

Expired US Patents for INSPRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-003	Sep 27, 2002
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-002	Sep 27, 2002
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-002	Sep 27, 2002

International Patents for INSPRA

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

Country	Patent Number	Title	Estimated Expiration
Indonesia	29778
Taiwan	I238716
Germany	60005159

Supplementary Protection Certificates for INSPRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1135139	C01135139/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0122232	300144	Netherlands		300144, 20040410, EXPIRES: 20090409
0122232	2004C/008	Belgium		PRODUCT NAME: EPLERENONE; NATIONAL REGISTRATION NO/DATE: 241 IS 188 F3 20041220; FIRST REGISTRATION: NL RVG 29963 20040316

INSPRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Inspra (Eplerenone)

Introduction to Inspra (Eplerenone)

Inspra, also known by its generic name eplerenone, is a medication used in the treatment of chronic heart failure and hypertension. It belongs to the class of antimineralocorticoid receptor antagonists (MRAs), which play a crucial role in managing conditions associated with excessive aldosterone levels.

Market Segmentation and Product Positioning

Inspra is part of the broader chronic heart failure drugs market, which is segmented by various drug classes. Within this market, Inspra falls under the antimineralocorticoid/MRAs category, alongside other drugs like spironolactone (Aldactone) and finerenone (Kerendia)[1].

Clinical Use and Efficacy

Inspra is used as an adjunct to standard optimal therapy, which typically includes ACE inhibitors and/or ARBs, and beta blockers. The drug has been shown to reduce the risk of hospitalization and mortality in adult patients with New York Heart Association (NYHA) class II chronic heart failure and left ventricular systolic dysfunction. Studies have indicated that eplerenone can reduce the number of initial hospitalizations for these patients[4].

Cost-Effectiveness and Pharmacoeconomic Analysis

The cost-effectiveness of Inspra has been evaluated in several pharmacoeconomic studies. A report by the Common Drug Review (CDR) analyzed the cost-utility and cost-effectiveness of eplerenone as an adjunct to standard therapy. The study found that, at the submitted price, eplerenone costs approximately $955 annually, and it appears to reduce the number of hospitalizations for patients with NYHA class II heart failure. However, the CDR noted some limitations in the manufacturer's economic evaluation, suggesting that a Markov model could have provided a more transparent and comprehensive analysis[4].

Market Size and Growth Trends

The global chronic heart failure drugs market, which includes Inspra, is expected to grow significantly over the forecast period from 2024 to 2031. This growth is driven by increasing prevalence of heart failure, advancements in treatment options, and an aging population. While specific market size data for Inspra alone is not readily available, the overall market for chronic heart failure drugs is projected to see substantial growth, with various drug classes contributing to this trend[1].

Key Players and Market Competition

Inspra is marketed by Pfizer, one of the major players in the global chronic heart failure drugs market. Other key players in this market include AstraZeneca, Bayer AG, Boehringer Ingelheim, and Novartis AG, among others. The competitive landscape is characterized by a diverse range of drug classes and brands, each with its own market share and growth trajectory[1].

Financial Performance and Revenue

While specific financial data for Inspra is not detailed in the available sources, the overall revenue from chronic heart failure drugs is significant. For instance, the global market for these drugs is expected to grow, driven by the increasing demand for effective treatments. Companies like Pfizer, which market Inspra, report substantial revenues from their cardiovascular portfolios, although the exact contribution from Inspra would need to be extracted from detailed financial reports[1].

Regulatory and Clinical Developments

Inspra has received regulatory approvals for its use in heart failure and hypertension. The drug continues to be part of clinical guidelines and treatment protocols. Any updates or new clinical data on Inspra would be closely monitored by regulatory bodies and could impact its market position. For example, feedback from regulatory agencies, such as the FDA, on patient-reported outcome data can influence the drug's usage and market dynamics[4].

Patient Access and Pricing

The pricing of Inspra is a critical factor in its market dynamics. The drug is priced at approximately $2.61 per day, or around $955 annually, which can affect patient access and adherence. Pharmaceutical companies often engage in pricing strategies and negotiations with healthcare providers and insurance companies to ensure broader access to their medications[4].

Future Outlook and Market Projections

The future outlook for Inspra is tied to the overall growth of the chronic heart failure drugs market. As new clinical trials and data become available, the market position of Inspra could be reinforced or challenged. The drug's continued inclusion in treatment guidelines and its cost-effectiveness will be key factors in its market trajectory.

Key Takeaways

• Clinical Efficacy: Inspra reduces hospitalization and mortality in patients with NYHA class II chronic heart failure.
• Cost-Effectiveness: The drug is cost-effective as an adjunct to standard therapy, reducing hospitalizations and associated costs.
• Market Competition: Inspra competes within a diverse market of chronic heart failure drugs, including ACE inhibitors, ARBs, and other MRAs.
• Financial Performance: Part of a larger and growing market for chronic heart failure treatments.
• Regulatory and Clinical Developments: Ongoing clinical trials and regulatory feedback can impact its market position.
• Patient Access and Pricing: Priced at around $955 annually, with pricing strategies influencing patient access.

FAQs

Q: What is Inspra used for? Inspra (eplerenone) is used to treat chronic heart failure and hypertension, particularly as an adjunct to standard optimal therapy.

Q: How does Inspra compare to other MRAs? Inspra is compared to other MRAs like spironolactone (Aldactone) and finerenone (Kerendia) in terms of efficacy and cost-effectiveness. Each has its own clinical profile and market position.

Q: What is the cost of Inspra? Inspra costs approximately $2.61 per day or around $955 annually.

Q: Is Inspra cost-effective? Yes, Inspra has been shown to be cost-effective by reducing the number of hospitalizations for patients with NYHA class II heart failure.

Q: Who markets Inspra? Inspra is marketed by Pfizer, a major player in the global pharmaceutical industry.