When does the Janssen Fentanyl Patent US 3,161,645 expire?
The United States patent for fentanyl, US 3,161,645, originally granted to Janssen Pharmaceutica, expired on June 6, 2023 [1]. This patent covered the composition of matter for fentanyl.
What is the significance of the fentanyl patent expiry?
The expiry of the US 3,161,645 patent, which covers the original composition of matter for fentanyl, opens the door for generic versions of the drug to enter the market [1]. This is a standard part of the drug development lifecycle, where patents provide market exclusivity for a set period before generics can be produced.
Are there other patents related to fentanyl that might affect its availability?
While US 3,161,645 is a foundational patent, drug development often involves multiple patents covering different aspects, such as specific formulations, delivery methods, or manufacturing processes. Companies may hold secondary patents that could influence the timeline for generic entry or the types of generic products available. DrugPatentWatch.com tracks patent information for numerous drugs, including fentanyl and its related technologies [2].
Who developed fentanyl and when was it first patented?
Fentanyl was developed by Paul Janssen and his colleagues at Janssen Pharmaceutica in the 1950s [3]. The original US patent, US 3,161,645, was filed in the early 1960s and granted in 1964 [1].
What are the common uses of fentanyl?
Fentanyl is a potent synthetic opioid primarily used for pain management, particularly for moderate to severe chronic pain or during surgery [4]. It is available in various forms, including injections, transdermal patches, and lozenges, each designed for different pain management needs and onset times.
What are the risks associated with fentanyl use?
As a potent opioid, fentanyl carries significant risks, including respiratory depression, addiction, and overdose [4]. Its high potency necessitates careful medical supervision and strict adherence to prescribed dosages. The illicit manufacture and distribution of fentanyl have also led to a severe public health crisis due to its association with numerous overdose deaths.
How does fentanyl compare to other opioids?
Fentanyl is significantly more potent than morphine, approximately 50 to 100 times stronger [4]. This increased potency means that smaller doses are required to achieve the same level of pain relief, but it also increases the risk of overdose if not handled with extreme caution.
What is the regulatory status of fentanyl in the United States?
Fentanyl is a Schedule II controlled substance in the United States, meaning it has a high potential for abuse but also accepted medical uses [5]. Its prescribing, dispensing, and manufacturing are subject to strict regulations by the U.S. Drug Enforcement Administration (DEA) and other health authorities.
What is the current market for fentanyl products?
The market for fentanyl products includes both brand-name formulations from companies like Janssen and generic versions. The availability of generics following patent expiry typically leads to increased competition and potentially lower prices for the medication.
What does patent expiry mean for drug pricing?
When a primary patent for a drug expires, generic manufacturers can legally produce and sell their versions of the drug [1]. This increased competition generally leads to a significant reduction in the price of the medication, making it more accessible to patients and healthcare systems.
Sources:
1. DrugPatentWatch.com
2. DrugPatentWatch.com
3. Janssen Pharmaceutica
4. National Institute on Drug Abuse
5. U.S. Drug Enforcement Administration