MINIPRESS XL Drug Patent Profile

Which patents cover Minipress Xl, and when can generic versions of Minipress Xl launch?

Minipress Xl is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in MINIPRESS XL is prazosin hydrochloride. There are seventeen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the prazosin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Minipress Xl

A generic version of MINIPRESS XL was approved as prazosin hydrochloride by TEVA PHARMS on September 12^th, 1988.

Summary for MINIPRESS XL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	27
Patent Applications:	1,850
DailyMed Link:	MINIPRESS XL at DailyMed

Recent Clinical Trials for MINIPRESS XL

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

Sponsor	Phase
Yale University	Phase 1/Phase 2
University of Washington	Phase 4
Fast Grants	Phase 2

See all MINIPRESS XL clinical trials

US Patents and Regulatory Information for MINIPRESS XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	MINIPRESS XL	prazosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019775-001	Jan 29, 1992		DISCN	No	No
Pfizer	MINIPRESS XL	prazosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019775-002	Jan 29, 1992		DISCN	No	No

Expired US Patents for MINIPRESS XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	MINIPRESS XL	prazosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019775-002	Jan 29, 1992	4,327,725
Pfizer	MINIPRESS XL	prazosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019775-001	Jan 29, 1992	4,092,315
Pfizer	MINIPRESS XL	prazosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019775-001	Jan 29, 1992	4,783,337
Pfizer	MINIPRESS XL	prazosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019775-001	Jan 29, 1992	5,082,668
Pfizer	MINIPRESS XL	prazosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019775-002	Jan 29, 1992	5,082,668

International Patents for MINIPRESS XL

See the table below for patents covering MINIPRESS XL around the world.

Country	Patent Number	Title	Estimated Expiration
Belgium	900817
Belgium	898819
Canada	1222950	DISPOSITIF OSMOTIQUE A DOUBLE ACTIVITE THERMODYNAMIQUE (OSMOTIC DEVICE WITH DUAL THERMODYNAMIC ACTIVITY)
Switzerland	669329
Yugoslavia	49977

Market Dynamics and Financial Trajectory for Minipress XL

Introduction to Minipress XL

Minipress XL, a once-a-day formulation of prazosin, is a significant player in the hypertension treatment market. Developed as a gastro-intestinal therapeutic system (GITS), it offers extended-release benefits, making it a preferred choice for managing mild and moderate essential hypertension.

Efficacy and Safety

Minipress XL has been proven to be highly effective in reducing both sitting and standing systolic and diastolic blood pressure. Clinical trials have shown that doses of 10 or 20 mg significantly lower blood pressure compared to placebo, with minimal changes in heart rate[1].

Market Performance

Minipress XL has consistently demonstrated strong market performance. It is one of Pfizer's key brands, contributing to the company's remarkable double-digit growth. The drug has led its respective market segment through continuous awareness and engagement initiatives[2][5].

Volume Growth and Price Adjustments

Despite the revision of the National List of Essential Medicines (NELM) in February 2023, which led to price reductions for essential drugs, Minipress XL has managed to convert these price reductions into volume growth opportunities. This is evident from the positive performance in Q4 FY 2023-24 compared to Q3 2023-24[2][5].

Global Import Dynamics

The global import data for prazosin, the active ingredient in Minipress XL, shows a significant growth rate. Between March 2023 and February 2024, there was a 59% growth in imports compared to the preceding twelve months. This indicates a strong demand for the drug worldwide[4].

Financial Trajectory

Pfizer Limited, the manufacturer of Minipress XL, has seen a robust financial performance driven in part by this drug. Here are some key financial highlights:

• Net Revenue: Pfizer has reported steady net revenue growth, with figures such as ₹2,096 crore in FY20, ₹2,530 crore in FY22, and ₹2,338 crore in FY23. The company has managed to sustain growth despite market challenges[2][5].
• EBITDA Margin: The EBITDA margin has remained stable, ranging from 27% to 33% across different financial years, indicating efficient operations and cost management[2][5].
• Profit After Tax: The profit after tax has also shown a positive trend, with ₹509 crore in FY20, ₹613 crore in FY22, and ₹624 crore in FY23. This reflects the company's ability to maintain profitability[2][5].
• Dividend Per Share: Pfizer has consistently paid dividends, with amounts such as ₹330 per share in FY20 and ₹35 per share in FY23, demonstrating financial stability and shareholder value[2][5].

Marketing and Distribution Strategies

Pfizer has implemented several strategies to enhance the market performance of Minipress XL:

• Expanding Sales Footprint: The company has focused on expanding its sales and distribution footprint to reach more doctors and patients[5].
• Marketing Initiatives: Sharpened marketing initiatives have been crucial in maintaining the drug's market lead. This includes creating focused teams for adult vaccination awareness and other targeted marketing efforts[5].
• Product Innovations: Launching new SKUs and innovations within the established portfolio has helped in sustaining growth momentum[5].

Regulatory and Market Challenges

Despite the strong performance, the pharmaceutical industry, including Pfizer, faces several challenges:

• Price Control: The revision of the National List of Essential Medicines (NELM) and subsequent price reductions have required strategic adjustments to maintain volume growth[2][5].
• Regulatory Changes: Changes such as the Goods and Services Tax (GST) implementation and guidelines on generic prescriptions have posed short-term revenue impacts and required adaptability[3].

Global Reach and Import Data

Minipress XL is imported and distributed globally, with significant imports noted in countries such as India, the United States, Italy, Canada, and Germany. The import data highlights the drug's global demand and the extensive supply chain network[4].

Conclusion

Minipress XL has established itself as a leading treatment for hypertension, driven by its efficacy, safety, and strategic marketing efforts. Pfizer's financial performance, despite regulatory and market challenges, underscores the drug's importance in the company's portfolio.

Key Takeaways

• Efficacy and Safety: Minipress XL is highly effective in reducing blood pressure with minimal side effects.
• Market Performance: The drug has led its market segment with double-digit growth.
• Financial Trajectory: Pfizer has maintained strong financials, including net revenue, EBITDA margin, and profit after tax.
• Marketing Strategies: Expanding sales footprint, sharpened marketing initiatives, and product innovations have been key.
• Global Reach: The drug is widely imported and distributed globally.

FAQs

Q: What is Minipress XL used for? A: Minipress XL is used to treat mild and moderate essential hypertension.

Q: How does Minipress XL work? A: It works by reducing blood pressure through its extended-release formulation of prazosin.

Q: What are the common side effects of Minipress XL? A: Common side effects include headache, dizziness, and fatigue, which are generally mild to moderate in severity[1].

Q: How has the price reduction of essential drugs affected Minipress XL? A: Despite price reductions, Minipress XL has seen volume growth opportunities, contributing to positive performance in recent financial quarters[2][5].

Q: What are Pfizer's strategies to maintain market lead for Minipress XL? A: Pfizer focuses on expanding sales footprint, sharpening marketing initiatives, and launching new SKUs to sustain growth momentum[5].