Niravaribx 100 mg capsule
by Acuity Pharmaceuticals plc, reading on US11091459
- [1.a]92
- [1.b]90
- [1.c]58
- [1.d]95
Rationale
Generic ANDA filing discloses an XRPD fingerprint and excipient profile that read directly on claim 1 limitations [1.a] through [1.d].
Top evidence
“Active ingredient is the tosylate monohydrate of compound A in a stable crystalline form, with XRPD peaks at 7.5°, 15.2°, and 22.7° (Cu Kα).”
Key findings
- Owner: Tesaro / GSK
- Claims hit: 4 of 12
- All four limitations of claim 1 read on the ANDA's chemical fingerprint
- XRPD pattern matches the patented Form I precisely
- Same indication: maintenance treatment of recurrent epithelial ovarian cancer