Niravaribx 100 mg capsule reads on US 11,091,459
Acuity Pharmaceuticals plc · matched against Niraparib salt and crystalline forms thereof (owner: Tesaro / GSK) · claims hit 4 of 12
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).”
fda.gov / accessdata.fda.gov
Key findings
- All four limitations of claim 1 read on the ANDA's chemical and physical fingerprint
- XRPD pattern matches the patented Form I precisely
- Same indication: maintenance treatment of recurrent epithelial ovarian cancer