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-two 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
Malaysia	7300007	NEW PYRAZINE DERIVATIVE
United Kingdom	1249443
Netherlands	138933
France	2035890
Switzerland	547809	VERFAHREN ZUR HERSTELLUNG VON PYRAZINDERIVATEN.
U.S.S.R.	514570
Canada	952112	PYRAZINE DERIVATIVES AND PROCESS FOR THEIR PREPARATION

Market Dynamics and Financial Trajectory for Glucotrol

Last updated: February 27, 2026

What Is the Current Market Position of Glucotrol?

Glucotrol (glipizide) is a second-generation sulfonylurea used to treat type 2 diabetes. It was first approved by the FDA in 1984. The drug's market share has declined with the rise of other oral antidiabetics, such as SGLT2 inhibitors and GLP-1 receptor agonists. Nonetheless, it remains a component of some treatment guidelines due to its cost-effectiveness and longstanding clinical use.

The global diabetes drug market was valued at approximately USD 70 billion in 2022, with the oral antidiabetic segment accounting for roughly 65%. Glucotrol's primary competitors include metformin, newer sulfonylureas, DPP-4 inhibitors, and SGLT2 inhibitors.

What Are the Factors Influencing Glucotrol's Market Dynamics?

Patent and Regulatory Landscape

Glucotrol is off patent in many jurisdictions; the original patent expired in 2004. Generic versions dominate supply, exerting downward pressure on prices. Limited pipeline updates and absence of new formulations restrict attractive innovation pathways, affecting market growth potential.

Competition and Therapeutic Alternatives

The landscape favors agents with better safety profiles and clinical outcomes. SGLT2 inhibitors and GLP-1 receptor agonists outperform sulfonylureas on cardiovascular and renal endpoints. The rise of these drugs narrows Glucotrol’s market share.

Cost and Accessibility

Generics make Glucotrol a low-cost option—average retail price in the US stands around USD 10-20 per pill. Cost sensitivity persists in healthcare settings with constrained budgets. Nevertheless, newer therapies' higher prices limit their use in cost-dependent markets.

Prescriber Trends

Clinical guidelines increasingly recommend metformin as first-line therapy. Sulfonylureas like Glucotrol are now second-line options, used when other drugs are contraindicated or after failure of initial therapy.

Geographic Factors

In developing markets, Glucotrol remains more prevalent owing to affordability. Its distribution depends on local regulatory approvals and healthcare infrastructure.

What Is the Financial Trajectory Outlook for Glucotrol?

Revenue Trends

U.S. sales peaked around USD 150 million annually in the late 1990s but have declined to approximately USD 70 million in recent years, according to IQVIA data. Globally, revenues mirror this downward trend due to increased competition and generic availability.

Pricing and Profitability

Generic status caps prices, leading to thin margins. Major pharmaceutical companies have divested or reduced investments in Glucotrol, shifting focus towards innovative, patent-protected treatments.

R&D and Market Forecasts

Innovative reformulations or combination products involving Glucotrol are limited. The overall market for sulfonylureas is contracting at a CAGR of approximately 3% over the next five years, driven by the shift towards newer drug classes.

Market Exit Risks

If prescribing trends continue favoring new therapies, Glucotrol could face reduced manufacturing and distribution, impacting profitability margins. Companies may phase out low-margin products to reallocate resources.

How Do Patent Expirations Impact Future Planning?

Patent expiry in 2004 opened the market to generic competition, accelerating revenue decline. No significant patent extensions or new formulations have emerged since then. Future considerations include potential biosimilar or combination drug developments, yet these are unlikely to impact Glucotrol directly.

Summary of Key Financial Metrics

Metric	2022 Estimate	Trend
U.S. Revenue	Approx. USD 70 million	Declining
Global Revenue	Approx. USD 100 million	Declining
Market Share	< 3% among oral antidiabetics	Contracting
Average Price/Pill	USD 10-20	Stable due to generics

Key Drivers and Barriers

Drivers: Low cost, established safety profile, availability in developing markets.

Barriers: Competition from newer drugs, safety concerns like hypoglycemia risk, lack of innovation, patent expirations.

Key Takeaways

• Glucotrol remains available primarily as a low-cost generic, with declining market share due to competition from newer drugs offering improved outcomes and safety profiles.
• Revenue has declined significantly since patent expiration in 2004, with US sales around USD 70 million in 2022.
• The shift in prescribing habits favors metformin as first-line, with sulfonylureas relegated to second-line use.
• Future profitability is limited unless innovative formulations or combination therapies are developed.
• Market contraction is expected at a CAGR of 3% over the next five years, influenced by the broader move toward novel antidiabetic agents.

FAQs

1. Will Glucotrol regain market share with new formulations?
Likely not, given the dominance of newer agents with better safety and efficacy profiles.

2. How does pricing of generics impact future revenues?
Pricing remains low; profit margins are thin, reducing incentives for sustained investment.

3. Can Glucotrol's niche markets expand?
Potentially in emerging markets where affordability influences prescribing habits.

4. Are there ongoing R&D efforts to update Glucotrol?
No significant pipeline developments are publicly announced; focus has shifted to other drug classes.

5. How will regulatory changes impact Glucotrol?
Stringent safety standards may reduce off-label use; approvals for new indications are unlikely unless reformulated as combination medications.

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References

[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] U.S. Food and Drug Administration. (2020). Glipizide Approval and Patent Status.
[3] European Medicines Agency. (2021). Generic Drug Market Overview.
[4] MarketWatch. (2022). Diabetes Drugs Market Forecast.
[5] World Health Organization. (2022). Global Diabetes Statistics.