cliffwatch

cyclophosphamide · Hikma · NDA 203856, 210735, 212501, 217150, 217651

Cyclophosphamide

Earliest generic entry, as listed · earliest of 13 marketed strengths
26 Jun 2035

Other strengths are listed to 15 Feb 2036; 7 of 13 marketed strengths have no unexpired patent or exclusivity listed.

Blocked by patent: US 9662342.

Listed patents · 3 unexpired

PatentClaimsExpires
US 10993952product15 Feb 2036
US 12329767product15 Feb 2036
US 9662342product26 Jun 2035

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 13

NDA · productFormStrengthListed expiry
203856 · 001 · RLDcapsule, oral25MGopen
203856 · 002 · RLDcapsule, oral50MGopen
210735 · 001 · RLDsolution, intravenous500MG/2.5ML (200MG/ML)26 Jun 2035
210735 · 002 · RLDsolution, intravenous1GM/5ML (200MG/ML)26 Jun 2035
210735 · 003 · RLDsolution, intravenous2GM/10ML (200MG/ML)26 Jun 2035
212501 · 001 · RLDsolution, intravenous500MG/2.5ML (200MG/ML)15 Feb 2036
212501 · 002 · RLDsolution, intravenous1GM/5ML (200MG/ML)15 Feb 2036
212501 · 003 · RLDsolution, intravenous2GM/10ML (200MG/ML)15 Feb 2036
217150 · 001 · RLDsolution, intravenous500MG/5ML (100MG/ML)open
217150 · 002 · RLDsolution, intravenous1GM/10ML (100MG/ML)open
217150 · 003 · RLDsolution, intravenous2GM/20ML (100MG/ML)open
217651 · 001 · RLDsolution, intravenous500MG/2.5ML (200MG/ML)open
217651 · 002 · RLDsolution, intravenous1GM/5ML (200MG/ML)open