GLUCOTROL Drug Patent Profile

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

Glucotrol is a drug marketed by Pfizer and is included in two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Glucotrol

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

Summary for GLUCOTROL

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	15
Patent Applications:	4,271
Drug Prices:	Drug price information for GLUCOTROL
What excipients (inactive ingredients) are in GLUCOTROL?	GLUCOTROL excipients list
DailyMed Link:	GLUCOTROL at DailyMed

See drug prices for GLUCOTROL

Recent Clinical Trials for GLUCOTROL

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 clinical trials

US Patents and Regulatory Information for GLUCOTROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	GLUCOTROL	glipizide	TABLET;ORAL	017783-003	May 11, 1993		DISCN	Yes	No
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-003	Aug 10, 1999		DISCN	Yes	No
Pfizer	GLUCOTROL	glipizide	TABLET;ORAL	017783-001	May 8, 1984		DISCN	Yes	No
Pfizer	GLUCOTROL	glipizide	TABLET;ORAL	017783-002	May 8, 1984		DISCN	Yes	No
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-002	Apr 26, 1994	AB	RX	Yes	No
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-001	Apr 26, 1994	AB	RX	Yes	No

Expired US Patents for GLUCOTROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	GLUCOTROL	glipizide	TABLET;ORAL	017783-001	May 8, 1984	3,669,966
Pfizer	GLUCOTROL	glipizide	TABLET;ORAL	017783-002	May 8, 1984	3,669,966

International Patents for GLUCOTROL

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

Country	Patent Number	Title	Estimated Expiration
Denmark	128320
Germany	2012138
Spain	377925
Cyprus	645	New pyrazine derivatives
Belgium	747405
Finland	52720

Market Dynamics and Financial Trajectory for Glucotrol (Glipizide)

Last updated: July 28, 2025

Introduction

Glucotrol, formulated as Glipizide, is a widely prescribed oral antidiabetic medication developed by Pfizer. Approved by the Food and Drug Administration (FDA) in the early 1980s, Glucotrol remains a cornerstone in managing type 2 diabetes mellitus (T2DM). Its market presence has persisted due to its efficacy, low cost, and extensive clinician familiarity. This analysis explores the evolving market dynamics and financial trajectory of Glucotrol, considering recent trends, competitive pressures, and regulatory factors shaping its future.

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Market Landscape and Demand Drivers

The global diabetes epidemic has escalated over the past decade, with the International Diabetes Federation reporting approximately 537 million adults living with diabetes in 2021, projected to reach 643 million by 2030 [1]. This rising prevalence bolsters demand for antidiabetic agents like Glucotrol, which is indicated for glycemic control in T2DM.

Key demand drivers include:

• Established Efficacy: Glipizide’s proven ability to improve glycemic control has preserved its clinical relevance, especially in resource-limited settings where cost-effective therapies are paramount.
• Physician Prescribing Habits: Glyburide and Glipizide remain frequently prescribed due to long-standing familiarity and insurance formulary coverage.
• Pricing and Reimbursement: As a generic medication, Glucotrol benefits from affordability, fostering steady utilization in public health programs and private insurance plans.

Competitive Dynamics

The pharmaceutical landscape for T2DM therapies is fiercely competitive, with newer drug classes entering the market and shifting prescribing patterns:

• Emergence of SGLT2 Inhibitors and GLP-1 Receptor Agonists: Agents like empagliflozin and liraglutide offer additional benefits—cardiovascular and renal protection—prompting a gradual shift away from sulfonylureas, including Glucotrol [2].
• Safety Profile Concerns: Risks of hypoglycemia and weight gain associated with sulfonylureas have led clinicians to favor alternative drugs, impacting market share.
• Generic Competition: The expiration of patent exclusivity has increased price competition, further compressing margins for Pfizer and other producers of Glucotrol.

Regulatory Factors and Market Access

Regulatory agencies prioritize safety updates, with the FDA issuing warnings about hypoglycemia risks linked to sulfonylureas, potentially constraining overall use [3]. Market access is also influenced by formulary decisions, especially in managed health systems seeking to optimize cost-effectiveness.

Financial Trajectory and Revenue Trends

Pfizer’s revenue from Glucotrol peaked during the 2000s, reflecting widespread adoption. Post-patent expiration, revenue declines have been inevitable due to generic competition and declining market share.

• Revenue Decline: Industry reports indicate that US sales of Glucotrol have decreased significantly post-2010, paralleling the expiration of patent protections on older formulations [4].
• Generic Price Erosion: Competition has driven prices down, limiting profit margins. The global footprint of Glucotrol sales remains impacted by low-cost generics, especially in developing regions.
• Strategic Shift: Pfizer has gradually phased out marketed formulations to allocate resources toward newer, high-margin therapies.

Future Outlook and Growth Potential

The future trajectory for Glucotrol suggests an ongoing decline in revenue. However, niche markets—such as low-income countries and clinical settings where cost constraints dominate—may sustain limited demand. Additionally, combination therapies that include sulfonylureas might prolong their clinical utility.

Potential growth avenues include:

• Optimized Formulations: Development of longer-acting or fixed-dose combinations could marginally extend commercial relevance.
• Market Differentiation: Positioning as an affordable alternative amidst escalating healthcare costs may sustain demand in certain markets.
• Lifecycle Management: Patent litigations, formulations reformulations, and positioning in combination therapies could optimize revenues temporarily but are unlikely to reverse downward trends long-term.

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Implications for Stakeholders

• Investors: Expect diminishing revenue streams from Glucotrol but opportunities exist in emerging markets or niche applications.
• Pharmaceutical Companies: Focus should shift towards innovation in new drug classes rather than incremental gains from aging molecules.
• Healthcare Providers: Consideration of patient safety profiles and emerging guidelines will influence prescribing behaviors.
• Regulators: Evidence-based policies may continue to marginalize older agents like Glucotrol in favor of safer, more effective options.

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Key Takeaways

• The global increase in T2DM prevalence sustains baseline demand for older agents like Glucotrol, especially in cost-sensitive markets.
• Competition from newer classes and safety concerns have accelerated market share erosion, contributing to declining revenues.
• Patent expirations and generic proliferation have led to significant price erosion, impacting Pfizer’s profitability.
• Future growth prospects are limited; market focus should pivot towards innovative therapies with better safety and efficacy profiles.
• Stakeholders must adapt strategies aligned with evolving treatment guidelines, safety considerations, and economic factors influencing market dynamics.

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FAQs

1. Is Glucotrol still a viable treatment option for T2DM patients?
Yes, particularly in resource-limited settings or for patients who tolerate sulfonylureas well. However, clinicians increasingly prefer newer agents with better safety profiles.

2. How has patent expiration affected Glucotrol's market?
Patent expiration led to generic entry, eroding profit margins and reducing the medication’s market share as price competition intensified.

3. Are there safety concerns associated with Glucotrol?
Yes, risks of hypoglycemia and weight gain are prominent concerns, influencing prescribing trends towards alternative therapies.

4. What is the outlook for the future sales of Glucotrol?
Sales are expected to decline gradually, with potential for niche market retention but limited growth opportunities overall.

5. Can Glucotrol's formulations be modified for extended market viability?
While reformulations such as extended-release formulations exist, they face stiff competition and may not significantly alter the drug’s declining trajectory.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas, 2021.
[2] American Diabetes Association. Standards of Medical Care in Diabetes—2022.
[3] FDA Drug Safety Communications. Hypoglycemia Risks Associated with Sulfonylureas, 2019.
[4] IQVIA. Global Pharmaceutical Market Reports, 2022.