Viagra’s makers have announced they will stop producing the pills as they fear a US Food and Drug Administration decision could make them less than expensive.
The drug maker said Monday that it was “very disappointed with the FDA’s decision” but said the FDA “will consider an appeal” to allow the company to make the drug available in the US under its new name.
Viagra’s maker, Pfizer, has said it is taking steps to address the issue.
Pfizer’s patent on Viagra, which was originally granted for heart drugs and now sells for as little as $0.14 per pill, was approved by the FDA last August but a similar patent was still not in force. Viagra’s US patent on the heart drug Viagra expired in June.
“This is an important opportunity to address the problem of counterfeit drugs and ensure that those who purchase these drugs do not have a right to an affordable and safe drug that helps them to live longer,” said Jim Campbell, Pfizer’s head of strategic planning.
“This decision will be a huge step forward for Viagra, and it will allow patients to take charge of their own drug supply, while also addressing the cost of their prescriptions,” Campbell said.
The drugmaker has promised that it would be able to “continue to make substantial savings over time and continue to offer patients the option to buy the drug without a prescription and with the right information about the drug” and “continue to seek approval” from the FDA. The company said it is taking “no additional actions” and is working on other ways to make the drug available in the US under its new name.
The company has previously said it will not seek FDA approval to make Viagra available to patients without a prescription.
A spokesperson for Pfizer said the company is committed to working with the FDA to help patients make the drug available to them, and the company is “working closely with the FDA to ensure that patients do not have a right to an affordable and safe drug that helps them to live longer”.
The company has previously said it will “continue to offer patients the option to buy the drug without a prescription” and “continue to seek approval” for Viagra.
Pfizer said in a statement it was “working closely with the FDA” to ensure patients did not have a right to an affordable and safe drug that helps them to live longer, and will work with the FDA to ensure the drug is made available under its new name. Viagra’s US patent on the drug is still in force, but its maker, Pfizer, has said it is taking “no further actions”.
The company said the US drug patent on Viagra was not in force because of a legal requirement that Pfizer have “sufficient evidence of continued use” of the drug. Pfizer said it is “complying with the FDA’s position and will continue to work closely with the FDA to ensure that Viagra remains a safe and effective drug for use in the United States under the new name”.
Pfizer has been buying the drug for more than $1 billion in the past 12 months. Its US patents on the drug expire in March 2020, but a generic version of it is now available in the US. The company is also seeking approval to launch its generic version, in April 2020, under the name Viagra.
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