Monitor launch timing and initial market share capture for Everolimus tablets; IQVIA data will reveal competitive dynamics.
Price Chart
Executive Summary
ANI Pharmaceuticals received FDA approval for its generic Everolimus Tablets for Oral Suspension (2mg, 3mg, 5mg), a generic version of Afinitor Disperz. The U.S. market for this product is approximately $123 million annually (July 2026 MAT IQVIA data). The company remains on track to launch at least 15 new generics this year, adding momentum to its generics portfolio.
Key Facts
- FDA final approval for ANDA for Everolimus Tablets for Oral Suspension 2mg, 3mg, and 5mg
- Generic version of reference listed drug Afinitor Disperz
- U.S. annual sales for Everolimus Tablet for Oral Suspension approximately $123 million (July 2026 MAT IQVIA data)
- Company on track to launch at least 15 new generics in 2026
Financial Impact
Addressable market of ~$123 million annually; adds a new revenue stream to generics portfolio
Risk Factors
- Competitive launches from other generic manufacturers could erode market share and pricing
- Supply chain or manufacturing delays could impact launch timeline
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3367312 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 16, 2026 10d ago | Insider Cluster | $72.56 | awaiting T+60 | — | $72.60 (−0.06%) |
Sep 23, 2026 4w ago | Press Release | $74.43 | awaiting T+60 | — | $72.60 (−2.46%) |
Sep 16, 2026 5w ago | Insider Cluster | $75.39 | awaiting T+60 | — | $72.60 (−3.70%) |
Sep 14, 2026 6w ago | Insider Cluster | $72.11 | awaiting T+60 | — | $72.60 (+0.68%) |
Sep 1, 2026 7w ago | Insider Cluster | $73.06 | awaiting T+60 | — | $72.60 (−0.63%) |
Aug 24, 2026 9w ago | 8-K | $74.17 | awaiting T+60 | — | $72.60 (−2.12%) |
Aug 13, 2026 10w ago | Insider Cluster | $76.54 | awaiting T+60 | — | $72.60 (−5.15%) |
Aug 7, 2026 11w ago | 8-K | $78.25 | awaiting T+60 | — | $72.60 (−7.22%) |
Jul 16, 2026 14w ago | Court Ruling | $79.20 $73.59 | ▲ +7.08% | ▲ +11.77% | $72.60 (+8.33%) |
Jul 13, 2026 15w ago | Press Release | $81.08 $71.52 | ▼ −11.79% | ▼ −15.78% | $72.60 (−10.46%) |
US Market Status
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