AVANDAMET Drug Patent Profile

When do Avandamet patents expire, and what generic alternatives are available?

Avandamet is a drug marketed by Sb Pharmco and is included in one NDA.

The generic ingredient in AVANDAMET is metformin hydrochloride; rosiglitazone maleate. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; rosiglitazone maleate profile page.

Summary for AVANDAMET

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	14
Patent Applications:	4,871
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AVANDAMET
What excipients (inactive ingredients) are in AVANDAMET?	AVANDAMET excipients list
DailyMed Link:	AVANDAMET at DailyMed

Recent Clinical Trials for AVANDAMET

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
M.D. Anderson Cancer Center	Phase 1
Susan G. Komen Breast Cancer Foundation	Phase 1

See all AVANDAMET clinical trials

Paragraph IV (Patent) Challenges for AVANDAMET

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVANDAMET	Tablets	metformin hydrochloride; rosiglitazone maleate	1 mg/ 500 mg, 2 mg/ 500mg 4 mg/ 500 mg 2 mg/ 1000 mg 4 mg/ 1000 mg	021410	1	2004-10-22

US Patents and Regulatory Information for AVANDAMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-002	Oct 10, 2002		DISCN	Yes	No
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-004	Aug 25, 2003		DISCN	Yes	No
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-005	Aug 25, 2003		DISCN	Yes	No

Expired US Patents for AVANDAMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-001	Oct 10, 2002	7,358,366*PED
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-002	Oct 10, 2002	6,166,042*PED
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-003	Oct 10, 2002	6,288,095*PED

International Patents for AVANDAMET

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

Country	Patent Number	Title	Estimated Expiration
China	1101911
Germany	60019329
Japan	H09183726	MEDICINE FOR TREATMENT AND PROPHYLAXIS OF TROUBLE AND DISORDER OF GLUCOSE TOLERANCE

Supplementary Protection Certificates for AVANDAMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	132014902277722	Italy		PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
1532149	CA 2013 00001	Denmark		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
0861666	SPC/GB07/009	United Kingdom		SPC/GB07/009: 20070126

Market Dynamics and Financial Trajectory for Avandamet

Introduction

Avandamet, a combination drug containing rosiglitazone and metformin, was once a significant player in the treatment of type 2 diabetes. However, its market dynamics and financial trajectory have been heavily influenced by safety concerns, regulatory actions, and shifts in the antidiabetic drug market.

Background of Avandamet

Avandamet is one of the rosiglitazone-containing products, along with Avandia and Avandaryl, developed by GlaxoSmithKline (GSK). Rosiglitazone, a thiazolidinedione, was introduced to improve insulin sensitivity, while metformin helps reduce glucose production in the liver[1].

Initial Market Success

In the early 2000s, Avandamet and other rosiglitazone-containing products saw significant market success. The drugs were part of GSK's strong pharmaceutical portfolio, contributing to the company's financial performance. For instance, in 2006, the Avandia group of products was a key driver of GSK's turnover, which reached £23.2 billion[3].

Safety Concerns and Regulatory Actions

However, the market trajectory of Avandamet took a drastic turn due to safety concerns. Data suggesting an elevated risk of heart attacks in patients treated with rosiglitazone led to a significant regulatory response. In September 2010, the FDA announced restrictions on the use of rosiglitazone medicines, limiting them to patients who could not control their blood sugar with other medications and did not wish to use pioglitazone-containing alternatives[1].

Impact of REMS on Market Dynamics

The FDA implemented a Risk Evaluation and Mitigation Strategy (REMS) for Avandia, Avandamet, and Avandaryl, which included a restricted access and distribution program. This REMS, known as the Avandia-Rosiglitazone Medicines Access Program, drastically reduced the number of patients eligible to receive these medications. By October 2010, the number of patients filling rosiglitazone-containing prescriptions had declined by 50% compared to January 2010[1].

Decline in Prescriptions

The restrictions and safety concerns led to a steep decline in the use of thiazolidinediones, including rosiglitazone. By 2012, prescriptions for rosiglitazone-containing products had plummeted to nearly 1,000 from a peak of 12.7 million in 2006. This decline was part of a broader trend where the use of thiazolidinediones decreased by 64.0% between 2003 and 2012[4].

Financial Implications

The decline in prescriptions had significant financial implications for GSK and the overall market. The reduced sales of Avandia and its combination products contributed to a decrease in GSK's revenue from these drugs. This was evident in the company's financial reports, where the impact of generic competition and safety concerns on key products like Avandia were highlighted as factors affecting financial performance[3].

Market Shifts and New Competitors

The antidiabetic drug market has seen significant shifts since the decline of thiazolidinediones. New classes of drugs, such as DPP-4 inhibitors (e.g., sitagliptin) and GLP-1 analogs (e.g., liraglutide), have gained prominence. These newer drugs have captured a substantial share of the market, further reducing the relevance of Avandamet and similar products[4].

Current Market Status

As of the latest data, Avandamet and other rosiglitazone-containing products are no longer major players in the diabetes treatment market. The strict REMS program and the availability of safer, more effective alternatives have relegated these drugs to a niche role, primarily for patients who cannot be treated with other medications.

Financial Trajectory of Similar Pharmaceutical Companies

While Avandamet's financial trajectory has been negatively impacted, other pharmaceutical companies continue to evolve and adapt. For example, Avadel Pharmaceuticals, which focuses on developing and commercializing pharmaceutical products, has reported significant growth in net product revenue in recent quarters, albeit not directly related to Avandamet or rosiglitazone products[5].

Key Takeaways

• Safety Concerns: The discovery of increased heart attack risks associated with rosiglitazone led to stringent regulatory actions.
• REMS Program: The FDA's REMS program significantly restricted access to Avandamet and other rosiglitazone-containing products.
• Market Decline: Prescriptions for these drugs declined sharply, impacting GSK's revenue.
• Market Shifts: New classes of antidiabetic drugs have dominated the market, reducing the relevance of thiazolidinediones.
• Financial Impact: The decline in sales has had lasting financial implications for companies involved in the production and distribution of these drugs.

FAQs

What led to the decline in Avandamet prescriptions?

The decline in Avandamet prescriptions was primarily due to safety concerns regarding an increased risk of heart attacks associated with rosiglitazone, leading to FDA-imposed restrictions.

How did the REMS program affect Avandamet?

The REMS program restricted the use of Avandamet to patients already being successfully treated with the drug or those who could not control their blood sugar with other medications and did not wish to use pioglitazone-containing alternatives.

What are the current alternatives to Avandamet?

Current alternatives include DPP-4 inhibitors like sitagliptin and GLP-1 analogs like liraglutide, which have become more prominent in the treatment of type 2 diabetes.

How has the antidiabetic drug market evolved since the decline of Avandamet?

The market has shifted towards newer classes of drugs such as DPP-4 inhibitors and GLP-1 analogs, which offer safer and more effective treatment options.

What is the current financial status of companies involved in producing similar drugs?

Companies like Avadel Pharmaceuticals continue to report growth in net product revenue, though this is not directly related to Avandamet or rosiglitazone products. Instead, it reflects the broader evolution and adaptation in the pharmaceutical industry.

Sources

1. FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS)
2. Avadel Pharmaceuticals Corporate Update and Financial Reports
3. GSK Form 20F 2006
4. Use of Antidiabetic Drugs in the U.S., 2003–2012
5. Avadel Pharmaceuticals Press Releases