GLUCOTROL XL Drug Patent Profile

Which patents cover Glucotrol Xl, and what generic alternatives are available?

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

The generic ingredient in GLUCOTROL XL is glipizide. There are eighteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the glipizide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Glucotrol Xl

A generic version of GLUCOTROL XL was approved as glipizide by AUROBINDO PHARMA USA on May 10^th, 1994.

Summary for GLUCOTROL XL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	15
Patent Applications:	3,622
Drug Prices:	Drug price information for GLUCOTROL XL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLUCOTROL XL
What excipients (inactive ingredients) are in GLUCOTROL XL?	GLUCOTROL XL excipients list
DailyMed Link:	GLUCOTROL XL at DailyMed

See drug prices for GLUCOTROL XL

See drug sales revenues for GLUCOTROL XL

Recent Clinical Trials for GLUCOTROL XL

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

Sponsor	Phase
Memorial Sloan Kettering Cancer Center	Phase 2
Baylor College of Medicine	Phase 4
Novartis	Phase 2

See all GLUCOTROL XL clinical trials

Pharmacology for GLUCOTROL XL

Drug Class

Sulfonylurea

US Patents and Regulatory Information for GLUCOTROL XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-001	Apr 26, 1994		DISCN	Yes	No
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-002	Apr 26, 1994	AB	RX	Yes	Yes
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-003	Aug 10, 1999	AB	RX	Yes	No

Expired US Patents for GLUCOTROL XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-003	Aug 10, 1999	5,082,668
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-001	Apr 26, 1994	5,082,668
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-003	Aug 10, 1999	RE44459
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-002	Apr 26, 1994	4,612,008
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-002	Apr 26, 1994	5,091,190

International Patents for GLUCOTROL XL

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

Country	Patent Number	Title	Estimated Expiration
Australia	632859
Austria	397180
Norway	170834
South Africa	9006972
Switzerland	669329

Market Dynamics and Financial Trajectory for GLUCOTROL XL

Introduction

GLUCOTROL XL, an extended-release formulation of glipizide, is a significant player in the diabetes drug market, particularly for managing type 2 diabetes. This article delves into the market dynamics and financial trajectory of GLUCOTROL XL, highlighting its clinical efficacy, market size, and financial performance.

Clinical Efficacy and Usage

GLUCOTROL XL is designed to control blood sugar levels in patients with type 2 diabetes through the stimulation of insulin secretion. Clinical trials have demonstrated its effectiveness in reducing hemoglobin A1C, fasting plasma glucose, and postprandial glucose levels[1][4].

• Dosing and Administration: The drug is available in doses ranging from 5 mg to 60 mg, although doses above 20 mg are not recommended. It is administered once daily, and its extended-release formulation helps maintain effective plasma concentrations throughout the 24-hour dosing interval[1][4].
• Adverse Reactions: Common adverse effects include dizziness, diarrhea, nervousness, tremor, and flatulence. Hypoglycemia is a significant concern, affecting about 3.4% of patients in clinical trials[4].

Market Size and Growth

The global diabetes drug market is experiencing significant growth, driven by the increasing prevalence of type 2 diabetes.

• Global Market Size: The diabetes drug market was valued at USD 66 billion in 2023 and is projected to reach USD 132.36 billion by 2034, growing at a CAGR of 6.5% from 2024 to 2034. Type 2 diabetes, which accounts for 90% of all diabetes cases, is the primary driver of this growth[3].
• Segmentation: The oral segment, which includes GLUCOTROL XL, captured a 46% revenue share in 2023. Hospital pharmacies dominate the distribution channel, holding a 54% revenue share[3].

Financial Performance of GLUCOTROL XL

The financial performance of GLUCOTROL XL can be gauged from various market and sales data.

• Sales Figures: For the 12 months ending September 2003, GLUCOTROL XL generated sales of approximately $345 million, according to IMS data[5].
• Market Competition: The launch of generic versions of GLUCOTROL XL by companies like Watson Pharmaceuticals has impacted the market dynamics. Generic versions can reduce the market share of the branded drug but also indicate the drug's popularity and demand[5].

Pharmaceutical Industry Trends

The broader pharmaceutical industry trends also influence the financial trajectory of GLUCOTROL XL.

• Revenue Growth: Companies like Eli Lilly, which are involved in the diabetes drug market, have reported significant revenue growth. For example, Eli Lilly's worldwide revenue increased by 15% in 2021 compared to the previous year[2].
• Non-GAAP Measures: On a non-GAAP basis, many pharmaceutical companies, including those involved in diabetes treatments, have seen increases in gross margin and operating income. This indicates a healthy financial performance despite fluctuations in reported earnings[2].

Regional Stance

The demand for diabetes medications varies by region, influenced by demographic factors and healthcare infrastructure.

• Low-and-Middle-Income Countries: These regions are experiencing a rapid increase in diabetes cases, driven by rising obesity rates and demographic shifts. This trend is expected to further propel the demand for diabetes medications, including GLUCOTROL XL[3].

Challenges and Opportunities

The market for GLUCOTROL XL faces both challenges and opportunities.

• Challenges: The introduction of generic versions and the emergence of new diabetes treatments can pose challenges to the market share of GLUCOTROL XL. Additionally, the drug's side effects, such as hypoglycemia, need to be managed effectively[4].
• Opportunities: The growing prevalence of type 2 diabetes presents a significant opportunity for GLUCOTROL XL. Its efficacy in controlling blood glucose levels without deleterious changes in plasma lipoprotein profiles makes it a preferred choice for many patients[1].

Key Takeaways

• Clinical Efficacy: GLUCOTROL XL is effective in reducing blood glucose levels and is suitable for long-term use.
• Market Growth: The diabetes drug market is growing rapidly, driven by the increasing prevalence of type 2 diabetes.
• Financial Performance: GLUCOTROL XL has generated significant sales, although the introduction of generics may impact its market share.
• Regional Demand: The demand for diabetes medications is increasing globally, especially in low-and-middle-income countries.

FAQs

1. What is GLUCOTROL XL used for?

   • GLUCOTROL XL is used to control blood sugar levels in patients with type 2 diabetes.

2. How does GLUCOTROL XL work?

   • GLUCOTROL XL works by stimulating insulin secretion in response to meals, thereby reducing blood glucose levels.

3. What are the common side effects of GLUCOTROL XL?

   • Common side effects include dizziness, diarrhea, nervousness, tremor, and flatulence. Hypoglycemia is also a significant concern.

4. How big is the global diabetes drug market?

   • The global diabetes drug market was valued at USD 66 billion in 2023 and is expected to reach USD 132.36 billion by 2034.

5. What is the impact of generic versions on GLUCOTROL XL sales?

   • The introduction of generic versions can reduce the market share of the branded drug but also indicates the drug's popularity and demand.

Cited Sources

1. GLUCOTROL XL Label - FDA.
2. Lilly Reports Solid Fourth-Quarter and Full-Year 2021 Financial Results - Eli Lilly.
3. Diabetes Drug Market Size to Attain Around USD 132.36 Billion by 2034 - BioSpace.
4. Glucotrol XL (Glipizide Extended Release) - RxList.
5. Watson Pharmaceuticals, Inc. Launches Generic Glucotrol XL(R) 5 mg and 10 mg Tablets - BioSpace.