cliffwatch

cysteine hydrochloride · Exela Pharma · NDA 210660

Elcys

Earliest generic entry, as listed · earliest of 2 marketed strengths
15 Jan 2039

1 of 2 marketed strengths has no unexpired patent or exclusivity listed.

Blocked by patent: US 10478453, US 10583155, US 10653719, US 10905713, US 10905714, US 10912795, US 10918662, US 10933089, US 11510941, US 11510942, US 11642370, US 11648262, US 11679125, US 11684636, US 11826383, US 11969439.

Listed patents · 16 unexpired

PatentClaimsExpires
US 10478453product, use U-275215 Jan 2039
US 10583155product, use U-275215 Jan 2039
US 10653719product15 Jan 2039
US 10905713product15 Jan 2039
US 10905714product15 Jan 2039
US 10912795product15 Jan 2039
US 10918662product15 Jan 2039
US 10933089product15 Jan 2039
US 11510941product15 Jan 2039
US 11510942product, use U-275215 Jan 2039
US 11642370product15 Jan 2039
US 11648262product15 Jan 2039
US 11679125product15 Jan 2039
US 11684636product15 Jan 2039
US 11826383product15 Jan 2039
US 11969439use U-275215 Jan 2039

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 · 2

NDA · productFormStrengthListed expiry
210660 · 001 · RLDsolution, intravenous500MG/10ML (50MG/ML)15 Jan 2039
210660 · 002 · RLDsolution, intravenous2500MG/50ML (50MG/ML)open