History of Avapro's Approval for Hypertension and Nephropathy Treatment

The U.S. Food and Drug Administration (FDA) granted final approval for Avapro (active ingredient: irbesartan), a hypertension treatment developed by Sanofi-Aventis, on September 30, 1997. Avapro is an angiotensin II receptor blocker (ARB) that works by blocking the action of angiotensin II, a hormone that constricts blood vessels, thereby lowering blood pressure. It subsequently received additional approval for the treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, establishing itself as an essential treatment option for patients with cardiovascular and renal diseases. The accumulation of various clinical data after its initial approval helped build market credibility, which served as the foundation for its commercial success.

Strategic Alliance with BMS and Emergence as a Mega-Blockbuster

Sanofi formed a strategic alliance with Bristol Myers Squibb (BMS) to jointly develop and market Avapro. Under the collaboration between the two companies, Avapro and its combination drug, Avalide, gained tremendous popularity worldwide, achieving peak annual sales of over $2.5 billion (USD) before patent expiration. This partnership is considered a prime example of synergy achieved by combining BMS's strong sales network with Sanofi's development capabilities. Through global marketing collaboration, it was able to gain an advantage in the ARB market share competition against competing products such as Novartis's Diovan (active ingredient: valsartan) and Merck's Cozaar (active ingredient: losartan).

Partnership Restructuring Due to Patent Expiration and Generic Competition

Avapro faced fierce competition from low-cost generic drugs when its U.S. patent expired in 2012. Following the patent expiration, generic drugs entered the market, and the sales of the original Avapro declined by more than 50%, leading to a rapid restructuring of the market. As a result, Sanofi and BMS restructured their existing collaboration in late 2012, with BMS agreeing to transfer the global rights to Avapro and Plavix to Sanofi. This was a practical choice for pharmaceutical companies to switch to a single distribution structure in order to maximize marketing efficiency in the rapidly changing market situation after patent expiration.

Financial Agreement and Settlement Following Rights Transfer

As a result of the agreement, Sanofi agreed to pay BMS ongoing royalties until 2018 in exchange for receiving the global rights to Avapro, among other drugs. In addition, a terminal payment of $200 million (USD) was paid in December 2018 as a final settlement, marking the end of the long-standing joint venture between the two companies. Although the sales of the original Avapro brand declined significantly, the ARB market itself continues to grow, reaching approximately $28.4 billion in 2025. Sanofi has completely regained the rights and is exclusively securing the profits generated from the remaining patents and brand value to use as a resource for developing subsequent pipelines.