Pfizer’s reign over the smoking treatment space with its cessation med Chantix is coming to a close.
Trying to fill a recent shortage for Pfizer’s smoking med caused by safety concerns, the FDA has approved Par Pharmaceuticals’ copycat version, also known as varenicline, “well ahead” of its expected review date, the agency said a statement on Wednesday.
Though Pfizer’s generic rival Par Pharmaceuticals received the FDA’s special expedited treatment, impending copycat competition wasn’t unexpected given Chantix lost its main patent in November last year.
Chantix, first approved in 2006, drew in $1.1 billion in global sales back in 2019. The number fell 17% last year as the pandemic shuttered doctors offices. Most of Pfizer’s blockbuster sales can be attributed to its numerous price hikes over the years, according to GoodRx. In a 2018 report, the group found that Chantix’s price had more than doubled over 5 years.
But Chantix’s glory days are set to wind down with Par’s generic. It’s unclear when Endo, which owns Par, will start rolling out its copycat, although it’s likely imminent given the FDA’s hurry. A spokesperson wasn’t available for comment.
We know drug shortages are of great concern to the patients who rely on safe and effective medicines approved by FDA. https://t.co/Tx7Kgt5laU— Dr. Patrizia Cavazzoni (@FDACDERDirector) August 12, 2021
For months, people trying to wean off smoking have faced short Chantix supplies after Pfizer halted worldwide distribution in late June. That came after the drugmaker detected unacceptable levels of potential carcinogens, known as nitrosamines, in a number of Chantix lots. Weeks later, the company recalled certain batches in the U.S.
Nitrosamines, which are common in everyday life, are found in water and certain foods. High levels can increase the risk of cancer over time, Pfizer said.
Responding to the shortage, the FDA in July allowed certain manufacturers to temporarily distribute their tablets with N-nitroso-varenicline levels below an interim limit of 185 ng a day "until the impurity can be eliminated or reduced to acceptable levels." The agency also said patients should also continue using recalled Chantix lots since the dangers of smoking outweigh the cancer risk.
On top of that, the FDA temporarily allowed Apotex to distribute its generic Apo-Varenicline tablets, already used in Canada, in the U.S. prior to Par’s first generic approval on Wednesday.