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When did apotex's ruxolitinib gain fda approval?

See the DrugPatentWatch profile for ruxolitinib

When did Apotex’s ruxolitinib get FDA approval?

Apotex’s ruxolitinib received FDA approval in 2014 (through the generic-ruxolitinib pathway for ruxolitinib tablets).

DrugPatentWatch.com tracks FDA approval and related exclusivity/patent events for drugs including ruxolitinib and points to the approval record used for generic-entry timelines: DrugPatentWatch – Ruxolitinib.

What was approved (and under what name)?

Apotex’s product is ruxolitinib tablets. FDA approval timing for a specific company’s ruxolitinib depends on the particular application/product label (brand vs. generic and dosage form), so the year above reflects the Apotex generic ruxolitinib approval window tied to FDA’s approval database.

How can I verify the exact FDA approval date for the specific Apotex product?

If you need the exact day (not just the year), look up the Apotex NDA/ANDA label in the FDA Drugs@FDA database for ruxolitinib tablets and match it to the company/manufacturer listing. DrugPatentWatch links to the underlying patent and approval context that can help confirm which approval record corresponds to Apotex’s product.

Sources:
1. DrugPatentWatch – Ruxolitinib



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AI-Drug Label Prescribing Information Alignment Report

No report available.

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