On March 20, the patent on Semaglutide, the molecule used in GLP-1 drugs like Ozempic and Wegovy expired in India, allowing the release of cheaper alternatives.
According to an article by the BBC, this could cause prices to drop rapidly and increase access for patients across India, and eventually globally.
Senior Lecturer at Curtin Law School, Dr Nikos Koutras, says brand patents are essentially little monopolies, giving a pharmaceutical company the exclusive right to produce, market, and sell the medicine for around 20 years.
The current price of Ozempic and other GLP-1 medications in Australia is already quite steep, with Ozempic potentially becoming cheaper with a concession card.
Pharmacist and part-owner of Priceline Pharmacy Karrinyup, Barbara Kirk, says these medications are not covered by the Pharmaceutical Benefits Scheme or private health insurance, causing them to not be subsidised.
She says due to the lack of coverage, there isn’t a way for people to claim their money back.
“There has been talk of some of them coming on the PBS, just for certain conditions. So for people who have a BMI over thirty and congested cardiac failure, and a few other conditions, they are looking at potentially subsidising the semaglutide.”
The patent itself can also be a factor in the price of these medications.
Dr Koutras says it’s about the competition, or lack thereof.
“When a drug is under the patent, only one company is allowed to produce and sell it. This means there is no direct price competition, so the company can get a higher price, often justified on the basis that they need to recover research, and development costs.”
The patent for Semaglutide has not yet expired in Australia, because of strict guidelines set by the Therapeutic Goods Administration.
“The TGA say what can be sold, what’s available, and what people can have. They make sure everything is really safe for us,” Ms Kirk says.
“I think semaglutide was first patented in 2004, but they put a number of caveats on that, but that’s been extended, so I think the actual patent date for Australia can be anywhere up to 2031.”
She says semaglutide was first patented in 2004, and due to a number of caveats, the patent has been extended up to 2031.
Dr Koutras says when the patent does expire, generics must be approved by the TGA before they are allowed to be integrated.
“Initially generics don’t just enter the market, they are slowly integrated into our healthcare system.”
Ms Kirk says the patent not expiring yet and high costs may become a safety issue.
“The risk is people will import the medication from overseas, or buy it on the dark web, but there is no safety mechanisms around that.”