Orange Book product · Brand (NDA)
ELCYS
CYSTEINE HYDROCHLORIDE
At a glance
Apr 16, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
16
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 16, 2019
7 yr 3 mo ago
Today
Patent 10478453 expires
Listed drug product patent expiration.
Jan 15, 2039
in 12 yr 9 mo
Patent 10583155 expires
Listed drug product patent expiration.
Jan 15, 2039
in 12 yr 9 mo
Patent 10653719 expires
Listed drug product patent expiration.
Jan 15, 2039
in 12 yr 9 mo
Patent 10905713 expires
Listed drug product patent expiration.
Jan 15, 2039
in 12 yr 9 mo
Patent 10905714 expires
Listed drug product patent expiration.
Jan 15, 2039
in 12 yr 9 mo
Patent 10912795 expires
Listed drug product patent expiration.
Jan 15, 2039
in 12 yr 9 mo
Patent 10918662 expires
Listed drug product patent expiration.
Jan 15, 2039
in 12 yr 9 mo
Patent 10933089 expires
Listed drug product patent expiration.
Jan 15, 2039
in 12 yr 9 mo
Patent 11510941 expires
Listed drug product patent expiration.
Jan 15, 2039
in 12 yr 9 mo
Patent 11510942 expires
Listed drug product patent expiration.
Jan 15, 2039
in 12 yr 9 mo
Patent 11642370 expires
Listed drug product patent expiration.
Jan 15, 2039
in 12 yr 9 mo
Patent 11648262 expires
Listed drug product patent expiration.
Jan 15, 2039
in 12 yr 9 mo
Patent 11679125 expires
Listed drug product patent expiration.
Jan 15, 2039
in 12 yr 9 mo
Patent 11684636 expires
Listed drug product patent expiration.
Jan 15, 2039
in 12 yr 9 mo
Patent 11826383 expires
Listed drug product patent expiration.
Jan 15, 2039
in 12 yr 9 mo
Patent 11969439 expires
Listed method-of-use patent (U-2752) expiration.
Jan 15, 2039
in 12 yr 9 mo
Pharmaceutical detail
Active ingredient
CYSTEINE HYDROCHLORIDE
Strength
500MG/10ML (50MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 210660
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (16)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10478453 | Jan 15, 2039 | in 12 yr 9 mo | ProductU-2752 |
| 10583155 | Jan 15, 2039 | in 12 yr 9 mo | ProductU-2752 |
| 10653719 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 10905713 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 10905714 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 10912795 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 10918662 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 10933089 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 11510941 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 11510942 | Jan 15, 2039 | in 12 yr 9 mo | ProductU-2752 |
| 11642370 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 11648262 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 11679125 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 11684636 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 11826383 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 11969439 | Jan 15, 2039 | in 12 yr 9 mo | U-2752 |
