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-two 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:	154
Clinical Trials:	69
Patent Applications:	4,359
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 Pharma Metric Labs	N/A
PT Harsen Laboratories	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	AB	RX	Yes	Yes
Sanofi Aventis Us	AMARYL	glimepiride	TABLET;ORAL	020496-002	Nov 30, 1995	AB	RX	Yes	No
Sanofi Aventis Us	AMARYL	glimepiride	TABLET;ORAL	020496-003	Nov 30, 1995	AB	RX	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	020496-002	Nov 30, 1995
Sanofi Aventis Us	AMARYL	glimepiride	TABLET;ORAL	020496-003	Nov 30, 1995

International Patents for AMARYL

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

Country	Patent Number	Title	Estimated Expiration
Germany	3067390
Portugal	72226	SULFONYLHARNSTOFFE VERFAHREN ZU IHRER HERSTELLUNG PHARMAZEUTISCHE PRAPARATE AUF BASIS DIESER VERBINDUNGEN UND IHRE VERWENDUNG
Spain	8202798

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

AMARYL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AMARYL (Glimepiride)

Introduction

AMARYL, known generically as glimepiride, is a third-generation sulfonylurea used to manage type 2 diabetes. The market for glimepiride tablets is influenced by several key factors, including the increasing prevalence of diabetes, advancements in pharmaceutical technology, and the competitive landscape of the generic drug market.

Increasing Prevalence of Type 2 Diabetes

The global incidence of type 2 diabetes is on the rise, driven by factors such as aging populations, changing lifestyles, and increasing urbanization. This trend is a significant driver for the demand of glimepiride tablets, as they are an effective treatment for managing blood sugar levels[1].

Technological Advancements and Generic Versions

The availability of generic versions of glimepiride has made the drug more accessible and affordable. Technological advancements in medication formulation have also contributed to the market growth by improving the efficacy and safety profile of the drug. Generic versions, in particular, have reduced the cost, making glimepiride more appealing to a broader patient base[1].

Regional Market Analysis

North America

North America, particularly the United States and Canada, is a major contributor to the global glimepiride tablet market. The region's robust economy, technological advancements, and strong consumer base with high purchasing power support the market's growth[1].

Europe

Europe is another significant region, characterized by a mature market with well-established infrastructure and consumer preferences. Countries like the UK, Germany, France, and Italy are key players in this region[1].

Asia-Pacific

The Asia-Pacific region is experiencing rapid growth, driven by countries such as China, Japan, India, and South Korea. The large population, rising disposable income, and increasing urbanization in this region are boosting the demand for glimepiride tablets[1].

Latin America

Latin America presents both opportunities and challenges. Countries like Brazil, Mexico, and Argentina are key players, but economic fluctuations and political instability can impact market dynamics and consumer behavior[1].

Middle East and Africa

The Middle East and Africa are emerging markets with promising growth potential. Countries such as the UAE, Saudi Arabia, South Africa, and Nigeria are driving demand due to economic diversification efforts, urbanization, and a young population[1].

Competitive Landscape

The glimepiride tablet market is highly competitive, with several key players including:

• The Perrigo Company
• Hoechst Marion Roussel
• Elikem Pharmaceuticals Private Limited
• Sanofi
• Physicians Total Care, Inc.
• Apotex
• Sandoz
• Avera
• St. Marys
• RemedyRepack
• CorePharma LLC
• Glaxosmithkline Inc[1].

Financial Trajectory

Market Size and Growth

The global glimepiride tablet market is anticipated to witness significant growth, with a compound annual growth rate (CAGR) of 15.06% from 2024 to 2031. The market is expected to transition from a valuation of USD 9.65 billion in 2024 to USD 25.77 billion by 2031[1].

Impact of Generic Competition

The introduction of generic versions has a substantial impact on the market. Authorized generic drugs, in particular, reduce retail generic prices by 4-8% and wholesale generic prices by 7-14% during the 180-day exclusivity period. This competition also reduces the revenues of the first-filer generic manufacturer by 40-52% during this period[3].

Revenue and Pricing

The presence of authorized generics significantly affects the revenue of generic firms. However, it does not appear to reduce the incentives for generic firms to challenge patents, except in small markets or situations with low chances of winning the patent suit[3].

Clinical Efficacy and Safety

Efficacy

Glimepiride has been shown to be effective in reducing HbA1c levels and improving glycemic control. In clinical trials, glimepiride therapy resulted in a significant reduction in fasting plasma glucose and HbA1c levels, with 75% of patients achieving and maintaining control of blood glucose and HbA1c[5].

Safety Profile

The safety profile of glimepiride includes potential adverse effects such as hypoglycemia, weight gain, and allergic reactions. The overall incidence of hypoglycemia with glimepiride was approximately 14% in placebo-controlled trials. Other frequent adverse events include dizziness, asthenia, headache, and nausea[2][4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of glimepiride. The FDA approval and subsequent generic approvals have shaped the competitive landscape. The use of authorized generics as a form of consideration in patent litigation settlement agreements also influences market behavior[3].

Consumer Awareness and Healthcare Trends

Increased health consciousness and better diabetes treatment guidelines are driving the use of glimepiride tablets. Both patients and healthcare professionals are emphasizing the management of chronic diseases and preventive healthcare, further boosting market expansion[1].

Key Takeaways

• The glimepiride tablet market is driven by the increasing prevalence of type 2 diabetes and advancements in pharmaceutical technology.
• Generic versions have made the drug more accessible and affordable.
• Regional markets such as North America, Europe, and Asia-Pacific are significant contributors to the global market.
• The competitive landscape is dominated by several key players.
• The market is expected to grow significantly, with a CAGR of 15.06% from 2024 to 2031.
• Clinical efficacy and safety profiles are crucial for the drug's continued use.
• Regulatory and consumer trends continue to shape the market.

FAQs

1. What is the current market size and future growth prospects of the glimepiride tablet market?

   • The glimepiride tablet market is anticipated to grow from USD 9.65 billion in 2024 to USD 25.77 billion by 2031, with a CAGR of 15.06%[1].

2. Who are the key players in the glimepiride tablet market?

   • Key players include The Perrigo Company, Hoechst Marion Roussel, Elikem Pharmaceuticals Private Limited, Sanofi, and others[1].

3. What are the main factors driving the growth of the glimepiride tablet market?

   • The growth is driven by the increasing prevalence of type 2 diabetes, technological advancements, and the availability of generic versions[1].

4. What are the potential challenges affecting the glimepiride tablet market?

   • Challenges include competition from other generic drugs, regulatory hurdles, and economic factors such as fluctuations in Latin American markets[1][3].

5. How does the introduction of generic versions impact the market?

   • The introduction of generic versions, especially authorized generics, reduces prices and affects the revenues of first-filer generic manufacturers[3].

Sources

1. Glimepiride Tablet Market Size, Share and Forecast By Key Players - OpenPR
2. Amaryl: Package Insert / Prescribing Information - Drugs.com
3. Authorized Generic Drugs: Short-Term Effects and Long-Term Impact - Federal Trade Commission
4. Amaryl (glimepiride) - E-lactancia
5. AMARYL (glimepiride tablets) 1, 2, and 4 mg DESCRIPTION - FDA.gov