AVANDIA Drug Patent Profile

Which patents cover Avandia, and when can generic versions of Avandia launch?

Avandia is a drug marketed by Woodward and is included in one NDA.

The generic ingredient in AVANDIA is rosiglitazone maleate. There are twelve drug master file entries for this compound. Additional details are available on the rosiglitazone maleate profile page.

Summary for AVANDIA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	62
Patent Applications:	2,634
Drug Prices:	Drug price information for AVANDIA
What excipients (inactive ingredients) are in AVANDIA?	AVANDIA excipients list
DailyMed Link:	AVANDIA at DailyMed

See drug prices for AVANDIA

Recent Clinical Trials for AVANDIA

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

Sponsor	Phase
Dan Zandberg	Phase 2
University Health Network, Toronto	N/A
Barcelona Institute for Global Health	N/A

See all AVANDIA clinical trials

US Patents and Regulatory Information for AVANDIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-002	May 25, 1999		DISCN	Yes	No
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-003	May 25, 1999		DISCN	Yes	No
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-004	May 25, 1999		DISCN	Yes	No

Expired US Patents for AVANDIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-004	May 25, 1999
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-003	May 25, 1999
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-004	May 25, 1999
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-002	May 25, 1999

International Patents for AVANDIA

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	I288749
Argentina	023560	UNA FORMA POLIMORFICA DE ACIDO MALEICO DE UN DERIVADO DE TIAZOLIDIN-2,4-DIONA, COMPOSICION FARMACEUTICA Y EL USO DE LOS MISMOS PARA LA PREPARACION DE UNMEDICAMENTO
Norway	2001005
Japan	2828777

Supplementary Protection Certificates for AVANDIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0658161	C300035	Netherlands		PRODUCT: ROSIGLITAZONE,MALEAAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT.
0658161	SPC/GB01/003	United Kingdom		PRODUCT NAME: N-(4-(2(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY)BENZYL)THIAZOLIDINE-2,4-DIONE MALEIC ACID, "ROSIGLITAZONE MALEATE", ITS TAUTOMERS AND PHARMACEUTICALLY ACCEPTABLE SOLVATES; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711
0658161	CA 2001 00001	Denmark
0306228	SPC/GB01/002	United Kingdom		PRODUCT NAME: 5-(4-(2-(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY) BENZYL)-2,4-THIAZOLIDINEDIONE, "ROSIGLITAZONE" ITS TAUTOMERS, PHARMACEUTICALLY ACCEPTABLE SALTS, SUCH AS THE MALEATE, AND PHARMACEUTICALLY ACCEPTABLE SOLVATES.; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711

AVANDIA Market Analysis and Financial Projection Experimental

The Market Dynamics and Financial Trajectory of Avandia

Introduction

Avandia, a drug developed by GlaxoSmithKline (GSK) to treat Type 2 diabetes, has had a tumultuous history marked by significant market fluctuations and financial impacts. Here, we delve into the key events and factors that shaped the market dynamics and financial trajectory of Avandia.

Market Dominance and Initial Success

Launch and Early Adoption

Avandia, introduced in the early 2000s, quickly gained traction as a treatment for Type 2 diabetes. It became GSK's second-best-selling drug, generating $3.3 billion in global sales in the year preceding the major safety concerns[3].

Safety Concerns and Market Impact

Publication of the NEJM Study

In 2007, a meta-analysis published in the New England Journal of Medicine (NEJM) suggested that Avandia might increase the risk of heart attacks and cardiac deaths. This publication had an immediate and profound impact on the drug's market share. The study led to a sharp decline in new prescriptions and switches to Avandia from other medications[1].

Shift to Competitors

Following the NEJM study, physicians rapidly shifted their prescribing habits. Actos, a similar drug by Takeda, saw a significant increase in prescriptions, rising from 11% to almost 50% of switches in primary care offices in the immediate aftermath. Januvia, another diabetes medication by Merck, also benefited from the uncertainty surrounding Avandia, with its market share increasing as well[1][3].

Financial Consequences

Market Capitalization and Sales

The safety concerns led to a substantial financial hit for GSK. The company's market capitalization plummeted by $14 billion in just 48 hours following the NEJM publication. Analysts predicted that GSK would lose over a billion dollars due to the decline in Avandia sales[1].

Revenue Impact

Avandia's global sales, which had been robust, began to decline sharply. The drug's share of new prescriptions (NWRx) stabilized at around 6% after the initial drop, but this was a significant reduction from its previous market share[1].

Litigation and Regulatory Actions

FDA Actions and Label Changes

The FDA requested that both GSK and Takeda strengthen the warnings on their drugs' labeling regarding the risk of heart failure. An FDA advisory panel later voted to keep Avandia on the market despite concerns, but with additional warnings and the continuation of the TIDE trial to compare Avandia with Actos[4].

Litigation and Settlements

The safety concerns led to extensive litigation. GSK agreed to pay $460 million to settle a class action suit over Avandia. However, many personal injury cases were eventually dismissed or settled as the FDA determined that the supposed increased cardiovascular risks were not supported by science[2][4].

Marketing and Sales Strategies

Pharmaceutical Reps and Physician Influence

In response to the safety concerns, pharmaceutical companies adjusted their marketing strategies. GSK and Takeda increased their share of physician-reported details, indicating a heightened effort to influence prescribing decisions. Merck's "SWAT-like sales force" was particularly effective in promoting Januvia as an alternative to Avandia[1].

Long-Term Market Stabilization

Dissipating Concerns

Over time, physician and patient concerns about Avandia's safety began to dissipate. By mid-June 2007, primary care physicians' concerns had decreased, and patient concerns had also dropped. Avandia's market share stabilized, although at a significantly lower level than before the safety concerns arose[1].

Financial Recovery and Current Status

Share Price Recovery

While GSK's shares initially plummeted, they later recouped some of the losses. However, the long-term financial impact of the safety concerns and subsequent litigation was significant. The company had to navigate through extensive legal battles and settlements, which continued to affect its financial health[3].

Litigation Outcome

The Avandia litigation, which had been ongoing for over a decade, saw a significant decline in recent years. The exclusion of plaintiffs' economic loss experts' opinions marked a turning point, indicating that the legal challenges were finally subsiding[2].

Key Takeaways

• Avandia's market share eroded significantly following the publication of safety concerns in the NEJM.
• Competitors like Actos and Januvia benefited from the shift in prescribing habits.
• GSK faced substantial financial losses, including a $14 billion drop in market capitalization and over a billion dollars in predicted lost sales.
• Extensive litigation and regulatory actions followed, with GSK agreeing to settlements and label changes.
• Marketing strategies were adjusted to influence prescribing decisions, but long-term market stabilization occurred at a lower market share.

FAQs

Q: What was the immediate impact of the NEJM study on Avandia's market share?

A: The study led to a sharp decline in new prescriptions and switches to Avandia, with the drug's market share dropping significantly as physicians shifted to competitors like Actos and Januvia[1].

Q: How did the FDA respond to the safety concerns surrounding Avandia?

A: The FDA requested stronger warnings on the drug's labeling regarding heart failure and continued the TIDE trial to compare Avandia with Actos. An FDA advisory panel voted to keep Avandia on the market despite concerns[4].

Q: What was the financial impact on GSK due to the Avandia safety concerns?

A: GSK's market capitalization dropped by $14 billion in 48 hours, and the company was predicted to lose over a billion dollars in sales. Additionally, GSK agreed to pay $460 million to settle a class action suit[1][4].

Q: How did pharmaceutical companies adjust their marketing strategies in response to the safety concerns?

A: Companies like GSK, Takeda, and Merck increased their share of physician-reported details and deployed sales forces to influence prescribing decisions. Merck's "SWAT-like sales force" was particularly effective in promoting Januvia[1].

Q: What is the current status of Avandia litigation?

A: The Avandia litigation has largely subsided, with the exclusion of plaintiffs' economic loss experts' opinions marking a significant turning point. Most personal injury cases have been dismissed or settled, and the remaining claims are dwindling[2].

Sources

1. Pharmaceutical Executive: "Avandia Sales Away" - July 30, 2007.
2. Drug & Device Law: "Avandia Litigation - Is This Finally the End?" - November 11, 2024.
3. MM+M: "Actos gains market share at Avandia's expense" - No specific date.
4. U.S. Pharmacist: "Avandia to Remain on the Market" - August 19, 2010.