FDA Orange Book · active-ingredient family
Cysteine hydrochloride
Cysteine hydrochloride is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:NOURESS · NDA 212535
3
Brand (NDA)
0
Generics (ANDA)
20
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NOURESSRLD | BAXTER HLTHCARE CORP | NDA 212535 | — | Dec 13, 2019 | |
| ELCYSRLD×2 | EXELA PHARMA | NDA 210660 | — | Apr 16, 2019 | |
| CYSTEINE HYDROCHLORIDERLD | HOSPIRA | NDA 019523 | — | Oct 22, 1986 |
Listed patents (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11510942 | Jan 15, 2039 | in 12 yr 9 mo | ProductU-2752 |
| 11969439 | Jan 15, 2039 | in 12 yr 9 mo | U-2752 |
| 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 |
| 10918662 | 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 |
| 11684636 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 10933089 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 11826383 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 11679125 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 11648262 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 10912795 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 11642370 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 11510941 | Jan 15, 2039 | in 12 yr 9 mo | Product |
| 10543186 | Mar 15, 2039 | in 12 yr 11 mo | U-2722 |
| 11045438 | Mar 15, 2039 | in 12 yr 11 mo | Product |
| 10493051 | Mar 15, 2039 | in 12 yr 11 mo | Product |
| 10702490 | Mar 15, 2039 | in 12 yr 11 mo | Product |
Cysteine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
