When Did Apotex's Ruxolitinib Get FDA Approval?
Apotex's ruxolitinib cream (brand name Opzelura) received FDA approval on September 21, 2021, for treating mild to moderate atopic dermatitis in non-immunocompromised patients 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.[1]
What Is Opzelura Used For?
The approval covers topical application twice daily, with a maximum of 60 grams per week for adults and less for patients 12-17 years old. It's the first topical JAK inhibitor approved for this condition, targeting itch and inflammation by inhibiting JAK1 and JAK2 enzymes.[1][2]
How Does This Differ from Oral Ruxolitinib?
Incyte's original oral ruxolitinib (Jakafi) was approved in 2011 for myelofibrosis and later for graft-versus-host disease. Apotex's version is a topical cream formulation licensed from Incyte, avoiding systemic exposure risks of the pill form.[2]
When Do Patents Expire for Ruxolitinib Cream?
Key U.S. patents for ruxolitinib phosphate (the active ingredient) expire between 2025 and 2033, depending on formulation and indications. Opzelura-specific patents extend exclusivity, with challenges possible via Paragraph IV filings. Check DrugPatentWatch.com for the latest expiration dates and litigation updates.[3]
Are There Biosimilars or Generics Available Yet?
No generics for Opzelura exist as of now due to ongoing patent protections and no ANDA approvals. Oral Jakafi faces generic entry risks post-2025, but topical versions lag behind.[3]
[1]: FDA.gov - Approval Letter for Opzelura (September 21, 2021). https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215309Orig1s000lt.pdf
[2]: Incyte.com - Opzelura Product Information. https://www.opzelura.com/
[3]: DrugPatentWatch.com - Ruxolitinib Patents. https://www.drugpatentwatch.com/p/tradename/OPZELURA