METAGLIP Drug Patent Profile

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

Metaglip is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in METAGLIP is glipizide; metformin hydrochloride. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the glipizide; metformin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Metaglip

A generic version of METAGLIP was approved as glipizide; metformin hydrochloride by EPIC PHARMA LLC on October 27^th, 2005.

Summary for METAGLIP

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	4
Drug Prices:	Drug price information for METAGLIP
DailyMed Link:	METAGLIP at DailyMed

See drug prices for METAGLIP

Recent Clinical Trials for METAGLIP

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

Sponsor	Phase
Mylan Pharmaceuticals	Phase 1
Teva Pharmaceuticals USA	Phase 1

See all METAGLIP clinical trials

US Patents and Regulatory Information for METAGLIP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	METAGLIP	glipizide; metformin hydrochloride	TABLET;ORAL	021460-001	Oct 21, 2002		DISCN	Yes	No
Bristol Myers Squibb	METAGLIP	glipizide; metformin hydrochloride	TABLET;ORAL	021460-002	Oct 21, 2002		DISCN	Yes	No
Bristol Myers Squibb	METAGLIP	glipizide; metformin hydrochloride	TABLET;ORAL	021460-003	Oct 21, 2002		DISCN	Yes	No

METAGLIP Market Dynamics and Financial Trajectory: Generic Erosion, Discontinuation, and Commercial Outlook

Last updated: October 23, 2026

Metaglip, the fixed-dose combination of glipizide and metformin hydrochloride, is a mature type 2 diabetes product with limited remaining commercial value. U.S. brand exclusivity expired years ago, generic versions entered the market, and the branded product is listed by FDA as discontinued. Current revenue is therefore generated, if at all, through low-priced generic supply rather than through an active Metaglip brand franchise. Metaglip has no biosimilar exposure because it is a small-molecule drug, not a biologic. (FDA, 2002; FDA, 2024a)

What is Metaglip and how does it work?

Metaglip combines two established oral antidiabetic agents:

Attribute	Metaglip detail
Active ingredients	Glipizide and metformin hydrochloride
Therapeutic area	Type 2 diabetes
Drug class	Sulfonylurea plus biguanide
Dosage form	Oral immediate-release tablet
Original U.S. sponsor	Bristol-Myers Squibb
U.S. regulatory pathway	New drug application
FDA approval	2002
Current branded status	Discontinued in the United States
Biosimilar relevance	None
Generic status	Generic versions authorized and marketed historically

Glipizide stimulates pancreatic insulin secretion. Metformin reduces hepatic glucose production and improves insulin sensitivity. The combination was intended for patients inadequately controlled on either component alone, or for patients who would otherwise take the two medicines separately. (FDA, 2002)

Metaglip was an immediate-release product. It did not use an extended-release delivery system, an injectable formulation, or a device-based delivery platform. That limited its formulation differentiation relative to newer oral and injectable diabetes products.

When did Metaglip lose exclusivity?

Metaglip lost meaningful U.S. market exclusivity after the expiration of its initial regulatory protection and the entry of generic glipizide/metformin products.

The FDA approved Metaglip in 2002. As a new combination of previously known active ingredients, the product received limited regulatory exclusivity rather than the longer exclusivity associated with a new chemical entity. The principal commercial protection therefore depended on formulation, regulatory exclusivity, trademarks, and any listed patents rather than on protection for a new active ingredient. (FDA, 2002; FDA, 2024b)

Milestone	Approximate timing	Commercial effect
U.S. approval	2002	Brand launch
Initial three-year new-drug exclusivity period	Approximately through 2005	Delayed certain generic approvals based on the same combination
Generic approvals	Mid-2000s onward	Price and share erosion
Mature generic competition	Late 2000s and 2010s	Brand economics deteriorated
Brand discontinuation listing	Later commercial period	No active branded growth platform

The precise date of commercial discontinuation is less important than the market consequence: Metaglip moved from a branded combination product to a generic, low-margin product category. FDA’s Orange Book identifies the branded product as discontinued and distinguishes discontinued products from currently marketed products. (FDA, 2024a)

What patents protect Metaglip?

Metaglip has a weak current patent position because its active ingredients are old, widely available generic molecules and the branded product is no longer an active commercial franchise.

The principal intellectual-property categories were:

1. Combination-product claims covering glipizide and metformin in a single dosage form.
2. Formulation claims covering tablet composition and manufacturing.
3. Method-of-use claims covering treatment of type 2 diabetes.
4. Trademark rights covering the Metaglip name.

The active ingredients did not provide meaningful composition-of-matter exclusivity. Glipizide was approved decades before Metaglip, and metformin has an even longer clinical history. Any protection specific to the combination had to overcome the prior use of both molecules and the availability of the two products as separate tablets.

Public FDA records do not indicate a current, commercially significant Orange Book patent barrier for Metaglip. The product’s present status is consistent with ordinary generic erosion rather than continuing patent enforcement. (FDA, 2024a)

How strong is the Metaglip patent estate?

The estate is commercially weak for four reasons:

Factor	Assessment
New chemical entity protection	None
Current Orange Book blocking patent	No material active barrier identified
Formulation differentiation	Limited; immediate-release tablet
Manufacturing complexity	Low relative to biologics or modified-release products
Substitution risk	High
Litigation value	Low

A generic manufacturer does not face the technical barriers associated with sterile injectables, monoclonal antibodies, complex inhalers, or long-acting delivery systems. Glipizide and metformin are conventional oral solid-dose ingredients with established manufacturing processes.

What is the Orange Book status of Metaglip?

Metaglip is listed by FDA as a discontinued drug product. A discontinued listing does not itself establish that every generic version has stopped marketing. It indicates that the branded product is no longer marketed as an active product in the FDA drug-product database. (FDA, 2024a)

The Orange Book distinguishes among:

• Active marketed products;
• Discontinued products;
• Products with patent and exclusivity listings;
• Generic products approved through abbreviated new drug applications.

For Metaglip, the commercial relevance of Orange Book data is limited because the branded product no longer controls a growing market. The key competitive question is whether generic glipizide/metformin products remain available and whether prescribers and payers prefer separate generic tablets or newer combination therapies.

Which companies challenged Metaglip and supplied generic versions?

Generic competition came through abbreviated new drug application pathways rather than through a high-value patent contest. FDA product records identify multiple historical and current manufacturers across the glipizide/metformin category, including large generic suppliers and regional manufacturers. Availability has varied by strength, package size, wholesaler inventory, and manufacturing decisions. (FDA, 2024b)

The market structure is typical of mature oral generics:

• Initial generic entrants capture the largest price opportunity.
• Additional suppliers increase price pressure.
• Wholesalers and pharmacy-benefit managers shift volume to lower-cost sources.
• Some manufacturers discontinue low-margin presentations.
• Supply can become concentrated despite a nominally broad approval base.

The relevant competitive set is not limited to a product called “generic Metaglip.” Physicians can substitute the two active ingredients as separate generic tablets. This therapeutic substitution weakens the commercial value of a fixed-dose combination.

What generic entry risks exist for Metaglip?

Generic entry risk is effectively realized rather than prospective. The brand has already experienced the central loss-of-exclusivity events that determine its financial trajectory.

Price erosion

Generic glipizide and metformin are inexpensive, high-volume products. A fixed-dose combination can command a modest convenience premium in some channels, but that premium is constrained by:

• The low cost of the separate components;
• Broad payer coverage for generic metformin;
• Availability of glipizide as a low-cost generic;
• The ability of pharmacies to substitute or dispense alternatives;
• Competition from other diabetes combinations.

Volume erosion

Volume migrated away from the branded product for several reasons:

1. Generic substitution reduced branded prescriptions.
2. Physicians increasingly favored metformin-centered treatment algorithms.
3. Sulfonylureas lost share to DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, and insulin products in appropriate patients.
4. Fixed-dose combination use was divided among competing products and separate tablets.

The American Diabetes Association treatment framework increasingly emphasizes cardiovascular, kidney, weight, and hypoglycemia considerations. Those factors have reduced the strategic position of sulfonylurea-based combinations in many treatment pathways, especially where newer agents provide outcome benefits or weight-loss advantages. (American Diabetes Association Professional Practice Committee, 2024)

How does Metaglip compare with newer diabetes combinations?

Metaglip competes on price, not clinical differentiation.

Product or category	Main components	Commercial positioning	Relative Metaglip pressure
Metaglip	Glipizide/metformin	Low-cost immediate-release combination	Baseline
Separate generic tablets	Glipizide plus metformin	Lowest-cost flexible therapy	High
Janumet	Sitagliptin/metformin	Branded and later generic DPP-4 combination	Clinical and commercial substitute
Kombiglyze XR	Saxagliptin/metformin extended release	Modified-release DPP-4 combination	Convenience and class substitution
Synjardy	Empagliflozin/metformin	SGLT2 combination	Outcome and metabolic differentiation
Xigduo XR	Dapagliflozin/metformin	Extended-release SGLT2 combination	Outcome and convenience differentiation
GLP-1 receptor agonists	Various agents	Weight and glycemic efficacy	Strong class substitution
Insulin combinations	Various agents	Advanced glycemic control	Patient-segment substitution

Metaglip retains a narrow role where low acquisition cost and familiarity dominate. It lacks the cardiovascular, renal, weight-management, and hypoglycemia profile that supports premium pricing for several newer diabetes categories.

What was Metaglip’s financial trajectory?

No reliable public source provides a current standalone revenue series for Metaglip. Bristol-Myers Squibb historically reported revenue at company and portfolio levels rather than disclosing detailed annual sales for every mature product. Once generic competition developed, Metaglip revenue would have become immaterial relative to the company’s major products.

The financial trajectory can be characterized as follows:

Period	Revenue profile	Primary driver
2002 to early generic period	Launch and early growth	Combination convenience and brand promotion
Generic-entry period	Rapid decline	ANDA competition and substitution
Mature generic period	Low branded revenue	Price compression and reduced promotion
Discontinuation period	Minimal or zero branded revenue	Commercial withdrawal
Current period	Generic-category revenue only	Commodity demand and manufacturing economics

The absence of publicly reported product-level revenue is itself commercially relevant. A product with meaningful continuing sales would ordinarily appear in investor disclosures, transaction materials, or portfolio reporting. Metaglip does not have the profile of an active growth asset.

What FDA regulatory status does Metaglip have?

Metaglip was approved for adults with type 2 diabetes who required combination therapy with glipizide and metformin. It was not approved for type 1 diabetes or diabetic ketoacidosis. Its regulatory profile was conventional for an oral antidiabetic combination. (FDA, 2002)

There is no biologic license application, biosimilar pathway, or interchangeable-biologic issue associated with the product. Regulatory competition occurs through ANDAs and the substitution of separately administered generic ingredients.

The product also has limited lifecycle-management potential because:

• The active ingredients are old;
• The dosage form is conventional;
• Newer combinations have stronger commercial differentiation;
• A new formulation would face substantial competition from established diabetes products;
• The clinical market has moved toward therapies with outcome and weight-management advantages.

What patent litigation and Paragraph IV challenges affected Metaglip?

Metaglip did not develop into a major patent-litigation asset comparable to high-revenue branded diabetes products. Publicly visible commercial history points to generic approval and market substitution rather than sustained, high-value patent litigation.

Paragraph IV certifications may have been relevant to individual abbreviated applications depending on the patents listed at the time. A Paragraph IV certification asserts that a listed patent is invalid, unenforceable, or not infringed. It can trigger litigation and a potential 30-month stay under the Hatch-Waxman framework. There is no current litigation posture indicating that Metaglip retains a meaningful barrier to generic entry. (FDA, 2024b)

No major settlement agreement is central to the current commercial assessment of Metaglip. The product’s market outcome was determined primarily by age, generic availability, low manufacturing complexity, and therapeutic substitution.

What licensing deals shaped Metaglip’s commercial history?

There is no widely reported current licensing transaction that materially changes the Metaglip outlook. The product was associated with Bristol-Myers Squibb’s diabetes portfolio, but it did not become a platform asset with a continuing licensing or royalty stream comparable to newer branded medicines.

Any historical manufacturing, distribution, or commercialization arrangements would have limited residual value after brand discontinuation. A buyer evaluating Metaglip today would focus on generic approvals, manufacturing rights, inventories, trademarks, and regulatory files rather than on brand growth.

What geographic markets still matter for Metaglip?

The United States is the most relevant market for Orange Book, ANDA, and Hatch-Waxman analysis. Outside the United States, equivalent glipizide/metformin products may be marketed under different brand names, by different manufacturers, or as unbranded generics.

Geographic value is constrained by the global maturity of both active ingredients:

• Patent barriers are generally weak or expired.
• Local registration and manufacturing compliance remain necessary.
• Pricing is controlled by public reimbursement systems in many countries.
• Fixed-dose combination demand depends on national treatment guidelines.
• The same therapeutic substitution pressure exists in markets with broad access to metformin and sulfonylureas.

International sales cannot be inferred from the U.S. Metaglip brand status. A foreign product using the same active ingredients may have separate ownership, regulatory status, and commercial performance.

What manufacturing and intellectual-property barriers remain?

Manufacturing barriers are modest. The product is a conventional oral tablet and does not require:

• Recombinant-cell production;
• Aseptic filling;
• Cold-chain distribution;
• Complex device assembly;
• Specialized conjugation;
• Long-acting depot technology.

The main operational risks are ordinary generic-drug risks:

• Active pharmaceutical ingredient sourcing;
• Content uniformity and dissolution;
• Facility compliance;
• Batch release;
• Product availability by strength;
• Low-margin economics.

The strongest remaining protection is likely operational rather than legal. A manufacturer with reliable low-cost supply can compete, but it cannot expect meaningful brand-like pricing power.

What is the outlook for Metaglip revenue and generic launch scenarios?

The base case is continued commercial decline of the branded product with stable but low-value generic demand.

Scenario	Expected result
Base case	Generic supply continues; brand revenue remains negligible
Upside case	Temporary demand from low-cost diabetes treatment or supply shortages
Downside case	Further manufacturer exits and substitution to separate tablets or newer combinations
Strategic value case	Limited value in an acquisition of regulatory files or manufacturing rights
Litigation case	Low probability of economically significant patent enforcement

A generic manufacturer could obtain short-term volume during supply disruptions affecting separate glipizide or metformin products. That would be a supply-driven event, not evidence of durable market expansion.

Key Takeaways

• Metaglip is an immediate-release glipizide/metformin combination for type 2 diabetes.
• Bristol-Myers Squibb launched the product in the United States after FDA approval in 2002.
• Its regulatory exclusivity expired years ago, and generic competition is established.
• FDA lists the branded product as discontinued.
• No current Orange Book patent barrier appears to support meaningful brand exclusivity.
• The product has no biosimilar risk because it is a small-molecule oral drug.
• Revenue shifted from a branded prescription franchise to a low-margin generic category.
• Separate generic glipizide and metformin are major substitutes for the fixed-dose combination.
• Newer DPP-4, SGLT2, GLP-1, and insulin therapies weakened Metaglip’s clinical and commercial position.
• Residual value lies in generic manufacturing and supply reliability, not in patent protection or branded growth.

FAQs

Is Metaglip still available in the United States?

The branded Metaglip product is listed by FDA as discontinued. Equivalent glipizide/metformin products may remain available from generic manufacturers, subject to manufacturer and supply status. (FDA, 2024a)

Does Metaglip have an active U.S. patent?

No material current patent barrier is evident from the product’s discontinued status and established generic competition. Historical formulation or combination patents do not provide current brand protection once expired or no longer commercially blocking.

Can a generic company launch Metaglip without developing new clinical trials?

Generally, an applicant can rely on the ANDA pathway and demonstrate pharmaceutical equivalence and bioequivalence rather than repeat the full clinical development program required for a new drug. FDA requirements depend on the specific product and reference listing. (FDA, 2024b)

Is Metaglip safer than taking glipizide and metformin separately?

The fixed-dose combination uses the same active ingredients as separate tablets. The principal potential advantage is dosing convenience, while dose flexibility can be greater when the ingredients are prescribed separately. Clinical suitability depends on the patient’s treatment plan.

Why did Metaglip lose market share to newer diabetes drugs?

Metaglip faced low-cost generic competition and lacked the newer classes’ differentiation in weight reduction, cardiovascular outcomes, kidney protection, and reduced hypoglycemia risk in appropriate patient populations. (American Diabetes Association Professional Practice Committee, 2024)

References

American Diabetes Association Professional Practice Committee. (2024). 9. Pharmacologic approaches to glycemic treatment: Standards of care in diabetes - 2024. Diabetes Care, 47(Supplement 1), S158-S178. https://doi.org/10.2337/dc24-S009

U.S. Food and Drug Administration. (2002). Metaglip prescribing information. Bristol-Myers Squibb.

U.S. Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov

U.S. Food and Drug Administration. (2024b). Approved drug products and abbreviated new drug application database. https://www.fda.gov/drugs/drug-approvals-and-databases