AMARYL Drug Patent Profile

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

Amaryl is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in AMARYL is glimepiride. There are sixteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the glimepiride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Amaryl

A generic version of AMARYL was approved as glimepiride by CHARTWELL MOLECULAR on October 6^th, 2005.

Summary for AMARYL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	141
Clinical Trials:	69
Patent Applications:	4,275
Drug Prices:	Drug price information for AMARYL
What excipients (inactive ingredients) are in AMARYL?	AMARYL excipients list
DailyMed Link:	AMARYL at DailyMed

See drug prices for AMARYL

See drug sales revenues for AMARYL

Recent Clinical Trials for AMARYL

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

Sponsor	Phase
Damanhour University	N/A
PT Harsen Laboratories	N/A
PT Pharma Metric Labs	N/A

See all AMARYL clinical trials

US Patents and Regulatory Information for AMARYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	AMARYL	glimepiride	TABLET;ORAL	020496-001	Nov 30, 1995		DISCN	Yes	No
Sanofi Aventis Us	AMARYL	glimepiride	TABLET;ORAL	020496-002	Nov 30, 1995		DISCN	Yes	No
Sanofi Aventis Us	AMARYL	glimepiride	TABLET;ORAL	020496-003	Nov 30, 1995		DISCN	Yes	No

Expired US Patents for AMARYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AMARYL	glimepiride	TABLET;ORAL	020496-001	Nov 30, 1995
Sanofi Aventis Us	AMARYL	glimepiride	TABLET;ORAL	020496-003	Nov 30, 1995
Sanofi Aventis Us	AMARYL	glimepiride	TABLET;ORAL	020496-002	Nov 30, 1995

International Patents for AMARYL

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

Country	Patent Number	Title	Estimated Expiration
Denmark	540280
Spain	8202542
Denmark	156434

Supplementary Protection Certificates for AMARYL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1174135	SPC/GB10/011	United Kingdom		PRODUCT NAME: THE COMBINATION OF PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY THE HYDROCHLORIDE SALT, AND GLIMEPIRIDE.; REGISTERED: UK EU/1/06/366/001 20070108; UK EU/1/06/366/002 20070108; UK EU/1/06/366/003 20070108; UK EU/1/06/366/004 20070108; UK EU/1/06/366/005 20070108; UK EU/1/06/366/006 20070108; UK EU/1/06/366/019 20070108; UK EU/1/06/366/020 20070108; UK EU/1/06/366/021 20070108; UK EU/1/06/366/022 20070108; UK EU/1/06/366/013 20070108; UK EU/1/06/366/014 20070108; UK EU/1/06/366/015 20070108; UK EU/1/06/366/016 20070108; UK EU/1/06/366/017 20070108; UK EU/1/06/366/018 20070108; UK EU/1/06/366/007 20070108; UK EU/1/06/366/008 20070108; UK EU
0031058	98C0008	Belgium		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203
0031058	SPC/GB97/012	United Kingdom

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: AMARYL

Last updated: August 1, 2025

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Overview of AMARYL (Tolbutamide)

AMARYL (tolbutamide) is an oral sulfonylurea antidiabetic agent originally introduced in the 1950s. It functions by stimulating pancreatic beta-cell insulin secretion, thereby reducing blood glucose levels. Despite being one of the earliest oral hypoglycemics, its market presence has shifted owing to newer drug classes offering enhanced safety profiles.

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Market Evolution and Competitive Landscape

Initially, AMARYL capitalized on the burgeoning demand for oral hypoglycemics in the mid-20th century, particularly addressing Type 2 diabetes mellitus (T2DM). As the pharmaceutical industry progressed, newer agents—such as metformin, DPP-4 inhibitors, and SGLT2 inhibitors—offered superior efficacy, tolerability, and safety, gradually diminishing AMARYL's dominance.

The traditional market share of tolbutamide declined notably after the late 1980s, driven by concerns over hypoglycemia and cardiovascular risks associated with first-generation sulfonylureas. The shift was further accelerated by the advent of second- and third-generation sulfonylureas, including glimepiride and gliclazide, which provide longer duration of action and a more favorable side effect profile.

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Current Market Position and Usage

Today, AMARYL exists primarily in niche markets, often used in resource-constrained settings or in patients intolerant to newer agents. Its generic status underpins its affordability, making it relevant in lower-income regions. However, its prescription volume has sharply declined globally, with market data indicating minimal penetration in developed nations.

According to IQVIA data (2022), the global prescription volume of tolbutamide accounted for less than 0.1% of the total antidiabetic medication sales. The drug's usage persists mainly in countries with limited access to newer, more costly therapies.

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Market Drivers

• Cost-Effectiveness: AMARYL’s low price point acts as a significant driver in low-middle-income countries, where healthcare budgets restrict access to newer therapies.
• Existing Patent and Generic Status: The lack of patent protection has bolstered its availability as a low-cost generic, maintaining a degree of market presence.
• Provider Trust and Familiarity: Long-standing clinical familiarity promotes continued use among some healthcare providers, especially in areas with limited pharmaceutical innovation.

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Market Restraints

• Safety Concerns: Increased awareness of hypoglycemia risk and potential cardiovascular implications have led to reduced prescribing.
• Regulatory Withdrawal in Some Markets: Authorities like the FDA deprecated tolbutamide in the 1980s due to safety issues, leading to market discontinuation in certain regions.
• Emergence of Safer Alternatives: The superior safety profile of metformin and newer agents has reduced clinician reliance on sulfonylureas, including AMARYL.

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Financial Trajectory and Revenue Outlook

The financial outlook for AMARYL hinges on its global prescription volume, pricing dynamics, and the regulatory environment. Given its limited current use, revenue generated from AMARYLAL sales is minimal.

Forecasted Trends:

• Stagnation or Decline: In affluent markets, sales are expected to continue declining owing to phasing out of old sulfonylureas.
• Potential Niche Growth: In low-income settings, demand may slightly stabilize or grow marginally due to affordability and healthcare access limitations.
• Impact of Patent and Regulatory Status: If any regulatory bans or safety warnings tighten, market presence may further diminish.

Emerging Opportunities

Despite the overall declining trend, certain factors could influence the financial trajectory:

• Regulatory Re-approvals or Resurgence: If new safety data or formulations emerge, some regions might revisit AMARYL’s market status.
• Combination Formulations: Incorporation into fixed-dose combinations could renew interest, although currently, such formulations predominantly involve newer agents.
• Global Health Initiatives: International health organizations promoting affordable diabetes care could sustain or enhance uses in underserved markets.

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Market Risks and Challenges

• Regulatory Scrutiny: Increased oversight due to safety issues could lead to market withdrawal.
• Market Substitution: Healthcare providers’ preference for newer, safer drugs reduces demand.
• Manufacturing and Supply Chain: Obsolete manufacturing processes might raise costs, affecting affordability and competitiveness.

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Regulatory and Patent Considerations

Originally, tolbutamide held patents during its launch but lost patent exclusivity decades ago. The availability of generic versions has made AMARYL financially accessible but has also contributed to a commoditized market with low profit margins for manufacturers. Regulatory agencies continue to monitor safety data, which could influence future licensing or restrictions.

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Conclusion: Future Outlook

The financial trajectory of AMARYL remains subdued in developed healthcare markets due to safety concerns and therapeutic innovation shifting focus. However, in low-resource settings, it retains a niche role driven by cost considerations. The overall market for AMARYL is characterized by a declining trend, with limited upside unless new indications, formulations, or regulatory conditions favor its resurgence.

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Key Takeaways

• Declining Market: AMARYL's global prescription volume and revenue are in decline due to safety issues and competition.
• Niche Market Preservation: Its low cost sustains relevance in developing regions with limited access to newer therapies.
• Market Risks: Regulatory actions, safety concerns, and clinician preference favor safer, newer agents.
• Growth Opportunities: Niche applications, combination formulations, or re-evaluation by regulators could present minimal opportunities.
• Strategic Implication: Companies should focus on safer, innovative therapies but may consider AMARYL's role solely from a cost-focused, underserved market perspective.

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FAQs

1. Why has the prescription rate of AMARYL declined globally?
The decline is primarily due to safety concerns like hypoglycemia, cardiovascular risks, and the advent of newer, safer antidiabetic agents such as SGLT2 inhibitors and metformin, which offer better efficacy and safety profiles.

2. In which regions is AMARYL still actively used?
Its use persists mainly in low- and middle-income countries where affordability is critical and in healthcare systems with limited access to newer medications.

3. Are there ongoing regulatory efforts to restrict or withdraw AMARYL?
Certain regulatory agencies, including the FDA, historically deprecated tolbutamide due to safety concerns. Current regulatory actions vary by country, but the drug's market presence is limited globally.

4. Could AMARYL's role revitalize in the future?
Unlikely in developed markets; potential in niche markets hinges on regulatory re-evaluation or innovative formulations but remains highly uncertain.

5. How does patent status influence AMARYL's market?
Its patent expiration led to generic manufacturing, reducing costs and maintaining some market share in cost-sensitive regions but also limiting profitability for manufacturers.

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References

1. [1] IDF Diabetes Atlas, 9th edition, International Diabetes Federation, 2019.
2. [2] IQVIA Pharmaceuticals Data, 2022.
3. [3] US Food and Drug Administration, Drug Safety Communications, 1980s.
4. [4] World Health Organization, Access to Essential Medicines Report, 2020.
5. [5] European Medicines Agency, Safety updates on Sulfonylureas, 2018.