cysteine hydrochloride · Baxter Hlthcare Corp · NDA 212535

Nouress

Earliest generic entry, as listed
15 Mar 2039

Blocked by patent: US 10493051, US 10543186, US 10702490, US 11045438.

Listed patents · 20 unexpired

PatentClaimsExpires
US 10493051drug product · sets the listed date15 Mar 2039
US 10543186use U-2722 · sets the listed date15 Mar 2039
US 10702490drug product · sets the listed date15 Mar 2039
US 11045438drug product · sets the listed date15 Mar 2039
US 11510941drug product2 Mar 2039
US 10478453drug product, use U-275215 Jan 2039
US 10583155drug product, use U-275215 Jan 2039
US 10653719drug product15 Jan 2039
US 10905713drug product15 Jan 2039
US 10905714drug product15 Jan 2039
US 10912795drug product15 Jan 2039
US 10918662drug product15 Jan 2039
US 10933089drug product15 Jan 2039
US 11510942drug product, use U-275215 Jan 2039
US 11642370drug product15 Jan 2039
US 11648262drug product15 Jan 2039
US 11679125drug product15 Jan 2039
US 11684636drug product15 Jan 2039
US 11826383drug product15 Jan 2039
US 12569514drug product15 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 · 1

NDA · productFormStrengthListed expiry
212535 · 001 · RLDsolution, intravenous500MG/10ML (50MG/ML)15 Mar 2039