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When did apotex's ruxolitinib gain fda approval?

See the DrugPatentWatch profile for ruxolitinib

Apotex’s generic version of ruxolitinib—marketed as Jakafi®—was approved by the U.S. Food and Drug Administration on September 6, 2022. That approval covered the drug’s use for myelofibrosis and polycythemia vera, making it the first generic product for these indications.



Other Questions About Ruxolitinib :

How has apotex adapted to ruxolitinib's fda approval delays? How does ruxolitinib response differ with azacitidine combination? How do steroids influence ruxolitinib's side effects? What is the response rate for ruxolitinib and azacitidine combination? What is the exact date of apotex s ruxolitinib us filing? In what ways does ruxolitinib outperform azacitidine alone? What specific ingredients did apotex add to ruxolitinib?

AI-Drug Label Prescribing Information Alignment Report

Drug Brand Mention Assessment

Branding Score
28
Visibility
35
Mentioned
Ranking
#1
Sentiment
41
Recommendation Status
mentioned only
Brand Perception
Best Known For

2014 (through the generic-ruxolitinib pathway for ruxolitinib tablets)


Core Claims
  • Apotex’s ruxolitinib received FDA approval in 2014
  • Approval is through the generic-ruxolitinib pathway for ruxolitinib tablets
  • FDA approval timing depends on the particular application/product label
Differentiators
  • Approval year described as tied to the Apotex generic-ruxolitinib pathway
  • Exact timing depends on the specific application/product label (brand vs. generic and dosage form)

Pricing Perception: Not Mentioned
Competitors Mentioned
Company Visibility Sentiment Rank Recommended
DrugPatentWatch 10%
41 #3 No
FDA 10%
41 #2 No