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
| Patent | Claims | Expires |
|---|---|---|
| US 10478453 | drug product, use U-2752 · sets the listed date | 15 Jan 2039 |
| US 10583155 | drug product, use U-2752 · sets the listed date | 15 Jan 2039 |
| US 10653719 | drug product · sets the listed date | 15 Jan 2039 |
| US 10905713 | drug product · sets the listed date | 15 Jan 2039 |
| US 10905714 | drug product · sets the listed date | 15 Jan 2039 |
| US 10912795 | drug product · sets the listed date | 15 Jan 2039 |
| US 10918662 | drug product · sets the listed date | 15 Jan 2039 |
| US 10933089 | drug product · sets the listed date | 15 Jan 2039 |
| US 11510941 | drug product · sets the listed date | 15 Jan 2039 |
| US 11510942 | drug product, use U-2752 · sets the listed date | 15 Jan 2039 |
| US 11642370 | drug product · sets the listed date | 15 Jan 2039 |
| US 11648262 | drug product · sets the listed date | 15 Jan 2039 |
| US 11679125 | drug product · sets the listed date | 15 Jan 2039 |
| US 11684636 | drug product · sets the listed date | 15 Jan 2039 |
| US 11826383 | drug product · sets the listed date | 15 Jan 2039 |
| US 11969439 | use U-2752 · sets the listed date | 15 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 · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210660 · 001 · RLD | solution, intravenous | 500MG/10ML (50MG/ML) | 15 Jan 2039 |
| 210660 · 002 · RLD | solution, intravenous | 2500MG/50ML (50MG/ML) | open |