See the DrugPatentWatch profile for mounjaro
The patent for Mounjaro (tirzepatide) in India is not yet expired. As of 2023, the earliest expiry date for its primary patents in India is in 2032 [1].
What is Mounjaro and what is it used for?
Mounjaro is a medication developed by Eli Lilly and Company. It is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist [2]. Mounjaro is approved for the treatment of type 2 diabetes mellitus in adults, as an adjunct to diet and exercise [3].
How does Mounjaro work?
Mounjaro works by activating both GIP and GLP-1 receptors. These hormones play roles in regulating blood sugar and appetite. By mimicking their actions, Mounjaro helps to lower blood glucose levels and can lead to weight loss [2].
When does Mounjaro patent expire in other regions?
Patent expiries for Mounjaro vary by country. In the United States, the primary patents are expected to expire around 2036, though litigation is ongoing [1]. In Europe, patent expiries are also anticipated in the mid-2030s [1].
Are there any ongoing patent disputes for Mounjaro?
Yes, there are active patent disputes and challenges surrounding Mounjaro. Eli Lilly is involved in litigation to defend its patents, and third parties have initiated proceedings to invalidate them [1]. These legal challenges can potentially affect the timelines for generic competition.
Can generic versions of Mounjaro be available before patent expiry?
Generic versions of Mounjaro typically cannot be legally marketed before the relevant patents expire or are successfully invalidated in court. The outcome of ongoing patent litigation could influence when generic versions might become available in India [1].
What is the status of Mounjaro's regulatory approval in India?
As of late 2023, Mounjaro has not yet received marketing authorization from Indian regulatory authorities for the treatment of type 2 diabetes [4]. The timeline for its potential approval and availability in India remains to be determined.
What are the implications of Mounjaro's patent expiry?
When patents expire, it opens the door for generic manufacturers to produce and sell bioequivalent versions of the drug. This typically leads to increased competition and a reduction in drug prices, making the medication more accessible to patients [1].
Who is the manufacturer of Mounjaro?
Mounjaro is manufactured by Eli Lilly and Company [2].
Sources:
[1] https://drugpatentwatch.com/
[2] https://www.mounjaro.com/
[3] https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-tirzepatide-injection-type-2-diabetes
[4] https://www.thehindubusinessline.com/companies/eli-lilly-to-launch-new-diabetes-drug-in-india-by-2024/article67102610.ece