ACETOHEXAMIDE Drug Patent Profile

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Which patents cover Acetohexamide, and what generic alternatives are available?

Acetohexamide is a drug marketed by Ani Pharms, Usl Pharma, and Watson Labs Teva. and is included in five NDAs.

The generic ingredient in ACETOHEXAMIDE is acetohexamide. There is one drug master file entry for this compound. Additional details are available on the acetohexamide profile page.

Summary for ACETOHEXAMIDE

US Patents:	0
Applicants:	3
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	4
Patent Applications:	4,435
DailyMed Link:	ACETOHEXAMIDE at DailyMed

Recent Clinical Trials for ACETOHEXAMIDE

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

Sponsor	Phase
Drug Safety and Effectiveness Network, Canada
Canadian Institutes of Health Research (CIHR)
Canadian Network for Observational Drug Effect Studies, CNODES

See all ACETOHEXAMIDE clinical trials

Medical Subject Heading (MeSH) Categories for ACETOHEXAMIDE

Hypoglycemic Agents

Anatomical Therapeutic Chemical (ATC) Classes for ACETOHEXAMIDE

A10BB	Sulfonylureas
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for ACETOHEXAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	ACETOHEXAMIDE	acetohexamide	TABLET;ORAL	070870-002	Feb 9, 1987		DISCN	No	No
Usl Pharma	ACETOHEXAMIDE	acetohexamide	TABLET;ORAL	070754-001	Nov 3, 1986		DISCN	No	No
Ani Pharms	ACETOHEXAMIDE	acetohexamide	TABLET;ORAL	070870-001	Feb 9, 1987		DISCN	No	No
Usl Pharma	ACETOHEXAMIDE	acetohexamide	TABLET;ORAL	070753-001	Nov 3, 1986		DISCN	No	No
Watson Labs Teva	ACETOHEXAMIDE	acetohexamide	TABLET;ORAL	071894-001	Nov 25, 1987		DISCN	No	No

Acetohexamide Market Dynamics, Patent Status, and Financial Trajectory

Last updated: September 8, 2026

Acetohexamide is a first-generation sulfonylurea for type 2 diabetes that has effectively exited the commercial pharmaceutical market. Its historical brand, Dymelor, and generic products lost relevance as newer sulfonylureas, metformin, insulin analogs, DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors displaced older therapies. No meaningful current U.S. revenue base, active branded franchise, or visible generic competition exists. The financial trajectory is therefore one of completed lifecycle erosion rather than continuing market decline.

What is acetohexamide and how was it commercialized?

Acetohexamide is an oral hypoglycemic agent in the sulfonylurea class. It stimulates pancreatic beta cells to release insulin and was used for adults with type 2 diabetes when diet and exercise were insufficient.

Attribute	Acetohexamide
Active ingredient	Acetohexamide
Drug class	First-generation sulfonylurea
Historical brand	Dymelor
Dosage form	Oral tablets
Historical strength	Commonly 250 mg and 500 mg tablets
Primary indication	Type 2 diabetes mellitus
Regulatory era	Approved before the modern NDA system was fully standardized
Current commercial position	No meaningful U.S. commercial presence
Current treatment role	Obsolete or rarely used
Main historical competitors	Tolbutamide, chlorpropamide, tolazamide, glibenclamide/glyburide, glipizide, glimepiride

Acetohexamide was part of the first generation of insulin secretagogues. These products had low manufacturing complexity, but their commercial value depended on broad use in primary-care diabetes treatment. That market changed materially after metformin became the dominant first-line oral therapy and newer drug classes gained market share.

When did acetohexamide lose exclusivity?

Acetohexamide’s meaningful exclusivity expired decades ago. The product was introduced in the 1950s, before the Hatch-Waxman framework created the modern patent-and-regulatory exclusivity system. Any original composition-of-matter protection would have expired long before the current market period.

There is no credible basis for identifying a live U.S. market exclusivity period for acetohexamide. The commercial barriers that remain are not patent barriers. They are demand, regulatory maintenance, manufacturing economics, reimbursement, and clinical substitution.

Historical exclusivity timeline

Period	Commercial development
1950s	Acetohexamide entered the first-generation sulfonylurea market
1960s-1970s	Used as an oral treatment for type 2 diabetes
1980s-1990s	Generic competition and newer sulfonylureas reduced differentiation
1990s-2000s	Metformin and second-generation sulfonylureas increased pressure
2010s	DPP-4, GLP-1, and SGLT2 products further reduced clinical relevance
Current period	No material branded market and no identifiable high-value exclusivity

What patents protect acetohexamide?

No active, commercially significant U.S. patent estate has been identified for acetohexamide as an active ingredient, formulation, method of use, or manufacturing process.

The relevant intellectual-property position is best characterized as expired or commercially inactive:

• Original compound protection, if any, expired many decades ago.
• Historical formulation and manufacturing patents would also be outside their ordinary enforceable terms.
• No current Orange Book patent strategy is associated with acetohexamide.
• No meaningful patent-based barrier prevents manufacture of the active ingredient or conventional tablets.
• No known modern formulation franchise has created renewed exclusivity.

Because acetohexamide has no active branded U.S. product, there is no current patent estate comparable with those supporting modern diabetes products such as semaglutide, tirzepatide, empagliflozin, or linagliptin.

What is the Orange Book status of acetohexamide?

Acetohexamide does not have a meaningful current Orange Book position in the U.S. Orange Book listings are tied to approved drug products and their regulatory status. A discontinued or commercially inactive product does not create a practical reference-product franchise for current generic entry.

The key distinction is between:

1. A drug that has an approved reference listed drug with active commercial sales; and
2. A legacy active ingredient with no viable current market.

Acetohexamide falls into the second category. There is no visible current market in which an ANDA sponsor could create material value by challenging listed patents or launching against an established acetohexamide brand.

Are there Paragraph IV challenges or generic litigation?

No material current Paragraph IV litigation or generic patent challenge is associated with acetohexamide.

A Paragraph IV strategy normally requires a commercial opportunity large enough to justify formulation work, bioequivalence studies, regulatory filing costs, legal expenses, and launch risk. Acetohexamide does not offer that opportunity in the United States because:

• There is no significant branded product revenue to capture.
• No active patent estate appears to block entry.
• Physician use is minimal.
• Payer demand is weak.
• Competing diabetes medicines have stronger clinical and commercial positions.
• Manufacturing and distribution costs would be difficult to recover at low volumes.

Any historic generic entry would have occurred after the expiration of the relevant legacy exclusivity. Current litigation risk is therefore negligible.

What is the FDA regulatory status of acetohexamide?

Acetohexamide is a legacy FDA-approved diabetes medicine, but its current commercial and regulatory status is inactive or effectively discontinued in the U.S. The FDA’s Drugs@FDA and Orange Book systems distinguish between approval history and active marketing. Historical approval does not establish that a product remains commercially available.

The regulatory position has several implications:

• Historical approval does not guarantee current supply.
• A company seeking to reintroduce the product could face regulatory maintenance and manufacturing obligations.
• A new sponsor would need to assess whether an existing approved pathway remains usable or whether a new application would be required.
• A reintroduction would need current controls for identity, strength, purity, dissolution, stability, labeling, and manufacturing compliance.
• The absence of current demand would make the regulatory investment difficult to justify.

The FDA has not created modern exclusivity around acetohexamide comparable with orphan-drug, pediatric, qualified infectious-disease, or new chemical entity protections.

How has the diabetes market affected acetohexamide?

The diabetes market shifted away from first-generation sulfonylureas because of safety, tolerability, and clinical-practice considerations.

Clinical displacement

Acetohexamide has been displaced by:

• Metformin as the standard initial oral therapy for many patients.
• Second-generation sulfonylureas such as glipizide and glimepiride.
• DPP-4 inhibitors with lower hypoglycemia concerns in some populations.
• GLP-1 receptor agonists with weight-loss and cardiovascular positioning.
• SGLT2 inhibitors with cardiovascular, renal, and heart-failure benefits.
• Basal insulin and newer insulin delivery systems for patients requiring injectable therapy.

Sulfonylureas remain inexpensive, but acetohexamide lacks the price, availability, evidence base, and prescribing familiarity of the surviving members of the class.

Competitive comparison

Product or class	Market position versus acetohexamide	Main advantage
Metformin	Strongly superior commercial position	Low cost and guideline prominence
Glipizide	Strongly superior	Continued generic availability and clinical familiarity
Glimepiride	Strongly superior	Broad generic use and once-daily dosing
Glyburide	Superior but declining	Historical familiarity
DPP-4 inhibitors	Superior commercial relevance	Modern labeling and lower hypoglycemia positioning
GLP-1 receptor agonists	Far superior revenue profile	Weight and cardiometabolic benefits
SGLT2 inhibitors	Far superior revenue profile	Cardiovascular and renal outcomes
Acetohexamide	Marginal or absent	No current differentiation

What is the financial trajectory for acetohexamide?

Acetohexamide has no identifiable current revenue trajectory comparable with an active pharmaceutical product. Its financial lifecycle can be divided into four stages.

Launch and early adoption

The product entered a market in which oral sulfonylureas were important tools for treating type 2 diabetes. Early revenues were supported by limited therapeutic competition and the absence of modern alternatives.

Mature branded period

Dymelor and other acetohexamide products competed with first-generation sulfonylureas. Revenue depended primarily on prescribing volume rather than premium pricing. The product was an established therapy, but it had limited long-term differentiation.

Generic erosion

Once generic products became available, price competition reduced branded value. The active ingredient had low technical complexity, so manufacturing did not support a durable premium. Product economics became dependent on scale and distribution efficiency.

Commercial exit

The combination of low price, declining prescriptions, supply-chain complexity, and therapeutic substitution removed the economic rationale for continued promotion. The likely outcome was product withdrawal or near-total commercial abandonment.

No reliable public company filings provide current acetohexamide revenue, operating profit, market share, or prescription-volume data. Any numerical estimate of current sales would be speculative.

Are there licensing deals involving acetohexamide?

No significant current licensing, co-development, or commercialization agreement involving acetohexamide is publicly evident.

The asset does not present the characteristics that usually support a licensing transaction:

• No enforceable patent position.
• No differentiated formulation.
• No regulatory exclusivity.
• No growing patient population.
• No strategic fit with current diabetes portfolios.
• No pricing power.
• No clinical-development opportunity with an obvious return profile.

A historical manufacturing, distribution, or trademark arrangement may have existed during the product’s commercial life, but such arrangements would not represent a current platform opportunity.

What manufacturing and intellectual-property barriers exist?

The technical barrier to producing conventional acetohexamide tablets is low compared with complex biologics, modified-release products, sterile injectables, or device-based therapies.

Manufacturing considerations

A potential manufacturer would need to manage:

• Active pharmaceutical ingredient sourcing.
• Impurity and stability specifications.
• Tablet compression and content uniformity.
• Dissolution performance.
• Packaging and shelf-life validation.
• Good manufacturing practice compliance.
• Pharmacovigilance and product-quality reporting.
• Low-volume inventory economics.

The main barrier is commercial, not technical. A manufacturer could face minimum-order constraints, weak supplier interest, limited pharmacy demand, and an inability to achieve efficient production scale.

Intellectual-property considerations

The principal IP risk is not infringement. It is the absence of protectable differentiation. A company could potentially develop a new formulation or delivery system, but that would require clinical, regulatory, and commercial investment disproportionate to the market opportunity.

What generic launch scenarios exist?

Three launch scenarios can be identified.

Scenario	Probability assessment	Commercial outcome
Conventional tablet reintroduction	Low	Limited demand and weak returns
Specialty or shortage-driven supply	Low and episodic	Possible short-term supply sales, but limited franchise value
Reformulated or combination product	Very low	Development cost would exceed likely market value

A conventional generic launch would not face meaningful patent litigation, but it would face weak demand. The absence of patent barriers does not create an attractive market when the reference product has little or no commercial base.

How strong is the acetohexamide patent estate?

The current patent estate is effectively non-existent from a commercial strategy perspective.

Patent-estate factor	Assessment
Active composition patent	None of practical relevance
Active formulation patent	None of practical relevance
Method-of-use protection	None of practical relevance
Orange Book patent leverage	None of practical relevance
Paragraph IV exposure	Minimal
Freedom-to-operate risk	Low
Ability to support premium pricing	Very low
Licensing value	Very low

What is the outlook for acetohexamide?

The outlook is continued commercial irrelevance in the United States and other highly developed diabetes markets. The active ingredient may retain historical or limited reference value, but it has no evident pathway to regain material share without a new clinical positioning or formulation strategy.

That strategy would be difficult to finance. Modern diabetes development is concentrated in therapies that offer improved glycemic control, reduced hypoglycemia, weight reduction, cardiovascular benefit, renal benefit, or convenient delivery. Acetohexamide does not have a clear advantage in those categories.

Key Takeaways

• Acetohexamide is a legacy first-generation sulfonylurea with no meaningful current U.S. commercial market.
• Dymelor’s historical brand value has been eliminated by generic erosion and therapeutic substitution.
• Original patent and regulatory exclusivity expired decades ago.
• No active, commercially significant Orange Book patent estate is associated with the product.
• No material current Paragraph IV litigation, generic challenge, or settlement agreement is evident.
• Current revenue, market share, and prescription data are not publicly available at a meaningful level.
• The principal barriers to re-entry are weak demand and poor economics, not patents.
• Metformin, newer sulfonylureas, GLP-1 receptor agonists, and SGLT2 inhibitors have stronger clinical and commercial positions.
• A conventional generic launch would face low legal risk but unattractive returns.
• Acetohexamide has negligible licensing, acquisition, or investment value absent a major reformulation or new clinical strategy.

FAQs

Is acetohexamide still prescribed?

Acetohexamide is rarely prescribed in current U.S. clinical practice. Its use has been displaced by metformin, newer sulfonylureas, insulin, and newer cardiometabolic therapies.

Is Dymelor still available?

Dymelor is not a meaningful current U.S. commercial product. Historical approval and brand recognition do not establish present availability.

Can a company launch a generic acetohexamide product?

A company could evaluate a regulatory pathway, but commercial viability would be poor because the product has little apparent demand and no substantial branded market to target.

Does acetohexamide have patent protection outside the United States?

Any original international patent protection would have expired long ago. Country-specific regulatory registrations and product availability may differ, but they do not create a modern global exclusivity position.

Is acetohexamide an attractive pharmaceutical investment?

No. The asset has no visible revenue growth, limited clinical relevance, no meaningful patent moat, no evident licensing demand, and weak prospects for a profitable relaunch.

References

1. 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

2. DailyMed. (n.d.). Acetohexamide tablet. National Library of Medicine. https://dailymed.nlm.nih.gov/

3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/

4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

5. U.S. Food and Drug Administration. (n.d.). Drug patent and exclusivity information. https://www.fda.gov/drugs/development-approval-process-drugs/drug-patents-and-exclusivity

6. U.S. National Library of Medicine. (n.d.). Acetohexamide. MedlinePlus. https://medlineplus.gov/druginfo/meds/ a692018.html