GLIMEPIRIDE - Generic Drug Details

What are the generic drug sources for glimepiride and what is the scope of patent protection?

Glimepiride is the generic ingredient in six branded drugs marketed by Sanofi Aventis Us, Accord Hlthcare, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Carlsbad, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Pharms, Indoco Remedies, Micro Labs, Mylan, Norvium Bioscience, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Teva, Watson Labs, Takeda Pharms Usa, Sandoz, Sb Pharmco, and Teva Pharms Usa, and is included in twenty-two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for glimepiride. Thirty-two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for GLIMEPIRIDE

US Patents:	2
Tradenames:	6
Applicants:	22
NDAs:	22
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	32
Raw Ingredient (Bulk) Api Vendors:	154
Clinical Trials:	231
Patent Applications:	6,989
Drug Prices:	Drug price trends for GLIMEPIRIDE
Drug Sales Revenues:	Drug sales revenues for GLIMEPIRIDE
What excipients (inactive ingredients) are in GLIMEPIRIDE?	GLIMEPIRIDE excipients list
DailyMed Link:	GLIMEPIRIDE at DailyMed

See drug prices for GLIMEPIRIDE

See drug sales revenues for GLIMEPIRIDE

Recent Clinical Trials for GLIMEPIRIDE

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

Sponsor	Phase
Peking University First Hospital	Phase 4
Jiangsu Province Geriatric Institute	Phase 4
Peking University People's Hospital	Phase 4

See all GLIMEPIRIDE clinical trials

Generic filers with tentative approvals for GLIMEPIRIDE

Applicant	Application No.	Strength	Dosage Form
		8MG	TABLET;ORAL
		4MG	TABLET;ORAL
		2MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for GLIMEPIRIDE

Drug Class

Sulfonylurea

Anatomical Therapeutic Chemical (ATC) Classes for GLIMEPIRIDE

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 GLIMEPIRIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	GLIMEPIRIDE	glimepiride	TABLET;ORAL	202759-001	Jun 29, 2012	AB	RX	No	No
Ranbaxy Labs Ltd	GLIMEPIRIDE	glimepiride	TABLET;ORAL	076875-001	Oct 6, 2005		DISCN	No	No
Hikma Pharms	GLIMEPIRIDE	glimepiride	TABLET;ORAL	078952-002	Aug 1, 2013		DISCN	No	No
Dr Reddys Labs Ltd	GLIMEPIRIDE	glimepiride	TABLET;ORAL	077091-003	Oct 6, 2005	AB	RX	No	No
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-002	Nov 23, 2005		DISCN	Yes	No
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006	AB	RX	Yes	No	8,071,130		Y

Expired US Patents for GLIMEPIRIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AMARYL	glimepiride	TABLET;ORAL	020496-001	Nov 30, 1995	4,379,785*PED
Sanofi Aventis Us	AMARYL	glimepiride	TABLET;ORAL	020496-002	Nov 30, 1995	4,379,785*PED
Sanofi Aventis Us	AMARYL	glimepiride	TABLET;ORAL	020496-003	Nov 30, 1995	4,379,785*PED

GLIMEPIRIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Glimepiride

Introduction to Glimepiride

Glimepiride, a sulfonylurea, is a prescription drug used to treat type 2 diabetes. It is available in both brand-name (Amaryl) and generic forms. Understanding the market dynamics and financial trajectory of glimepiride is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Size and Growth Projections

The glimepiride tablet market has experienced rapid and substantial growth in recent years. Here are some key projections:

• The market is expected to continue its significant expansion from 2023 to 2031, with forecasts indicating robust growth rates throughout the forecast period[1][3][4].
• The global glimepiride market size was valued at USD xx billion in 2023 and is anticipated to reach USD xx billion by 2031, exhibiting a notable compound annual growth rate (CAGR)[3][4].

Market Segmentation

The glimepiride market is segmented based on several factors:

• Type: The market is categorized into different packaging types, such as 3 blisters/box and 10 blisters/box[1][3].
• Application: The drug is used for treating people with mild diabetes and those with severe diabetes[1][3].
• Geographical Regions: The market is analyzed across North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[1][3][4].

Drivers of Market Growth

Several factors are driving the growth of the glimepiride market:

• Increasing Prevalence of Diabetes: The rising incidence of type 2 diabetes globally is a significant driver, as more patients require effective treatments like glimepiride[4].
• Cost-Effectiveness: Glimepiride, being a generic drug, is generally more affordable than brand-name medications, making it a preferred choice for many patients[2][5].
• Market Penetration: The drug's widespread use and acceptance in various regions contribute to its market growth[1][3].

Restraints and Challenges

Despite the positive growth trajectory, there are some challenges:

• Competition from Other Diabetes Treatments: The diabetes treatment market is highly competitive, with various other medications and therapies available, which can impact glimepiride's market share[4].
• Regulatory Hurdles: Changes in regulatory policies and stringent approval processes can affect the market dynamics[4].

Financial Factors Affecting Glimepiride Costs

The cost of glimepiride can vary based on several financial factors:

• Dosage and Treatment Plan: Higher strengths of glimepiride (e.g., 4 mg vs. 2 mg) may cost more than lower strengths[2][5].
• Insurance Coverage: Patients with health insurance may pay less compared to those without insurance. The specific plan benefits and prior authorization requirements also play a role[2][5].
• Pharmacy and Supply Chain: The cost can differ depending on the pharmacy used and whether the medication is obtained through a mail-order pharmacy or in-person[2][5].

Cost-Saving Strategies

For patients looking to reduce their costs, several strategies can be employed:

• 90-Day Supply: Obtaining a 90-day supply of glimepiride, if approved by the insurance company, can reduce the number of trips to the pharmacy and lower costs[2].
• Mail-Order Pharmacies: Using mail-order pharmacies can help lower costs and provide the convenience of home delivery[2].
• Financial Assistance Programs: Various websites and programs offer savings cards and other financial assistance to help patients afford glimepiride[2].

Regional Market Analysis

The glimepiride market is analyzed across several major regions:

• North America: This region is expected to contribute significantly to the global market due to high healthcare spending and a large diabetic population[1][3][4].
• Europe: Europe also plays a crucial role, with a well-established healthcare system and a significant number of diabetes patients[1][3][4].
• Asia-Pacific: This region is anticipated to experience rapid growth due to the increasing prevalence of diabetes and improving healthcare infrastructure[1][3][4].

Competitive Landscape

The glimepiride market is competitive, with several key players:

• Physicians Total Care Inc.
• Sandoz
• Apotex
• GlaxoSmithKline Inc.
• Perrigo
• CorePharma LLC

These companies are focusing on strategies to strengthen their product portfolios and expand their market presence[4].

Key Takeaways

• The glimepiride market is poised for significant growth from 2023 to 2031.
• The market is driven by the increasing prevalence of diabetes and the cost-effectiveness of glimepiride.
• Financial factors such as dosage, insurance coverage, and pharmacy choice significantly affect the cost of glimepiride.
• Cost-saving strategies like obtaining a 90-day supply and using mail-order pharmacies can help reduce costs.
• The market is competitive, with several key players vying for market share.

FAQs

1. What are the main factors affecting the cost of glimepiride? The cost of glimepiride is influenced by factors such as dosage, treatment plan, insurance coverage, and the pharmacy used[2][5].

2. How does the cost of glimepiride vary with and without insurance? Without insurance, the cost of glimepiride is generally higher. With insurance, the cost depends on specific plan benefits and prior authorization requirements[2][5].

3. What are some cost-saving strategies for glimepiride? Patients can save costs by obtaining a 90-day supply, using mail-order pharmacies, and taking advantage of financial assistance programs[2].

4. Which regions are expected to contribute significantly to the glimepiride market? North America, Europe, and the Asia-Pacific region are anticipated to be major contributors to the global glimepiride market[1][3][4].

5. Who are the key players in the glimepiride market? Key players include Physicians Total Care Inc., Sandoz, Apotex, GlaxoSmithKline Inc., Perrigo, and CorePharma LLC[4].

Sources

1. Market Research Intellect - Global Glimepiride Tablet Market Size, Trends and Projections
2. Healthline - Glimepiride (Amaryl) Cost and Financial Assistance
3. Market Research Intellect - Global Glimepiride Tablet Market Size, Scope And Forecast Report
4. Cognitive Market Research - Glimepiride Market Report 2024 (Global Edition)
5. Medical News Today - Glimepiride cost 2024: Coupons and more