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FDA Orange Book · active-ingredient family

Cysteine hydrochloride

Cysteine hydrochloride: 3 brands, 0 generics; first approved Oct 22, 1986; on patent until Jan 15, 2039.

On patentHas discontinued products
Generic status & protection

Protected until Jan 15, 2039 (earliest listed patent expiry).

Earliest patent expiry Jan 15, 2039
Brands (NDA)
3
Generics (ANDA)
0
Listed patents
20
Next patent expiry
Jan 15, 2039
in 12 yr 8 mo
Originator applications

Brand (NDA) products

NOURESSRLD
NDA 2125352019
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
500MG/10ML (50MG/ML)SOLUTIONINTRAVENOUSDiscontinued—
ELCYSRLDRS
NDA 21066020192 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
500MG/10ML (50MG/ML)SOLUTIONINTRAVENOUSRx—
2500MG/50ML (50MG/ML)SOLUTIONINTRAVENOUSDiscontinued—
CYSTEINE HYDROCHLORIDERLD
NDA 0195231986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
7.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLEINJECTIONDiscontinued—
Protection horizon

Patent & exclusivity timeline

20262028203020322034203620382040TodayPatent 11510942 — 2039-01-15Patent 11510942Patent 11969439 — 2039-01-15Patent 11969439Patent 10478453 — 2039-01-15Patent 10478453Patent 10583155 — 2039-01-15Patent 10583155Patent 10653719 — 2039-01-15Patent 10653719Patent 10918662 — 2039-01-15Patent 10918662Patent 10905713 — 2039-01-15Patent 10905713Patent 10905714 — 2039-01-15Patent 10905714Patent 11684636 — 2039-01-15Patent 11684636Patent 10933089 — 2039-01-15Patent 10933089Patent 11826383 — 2039-01-15Patent 11826383Patent 11679125 — 2039-01-15Patent 11679125Patent 11648262 — 2039-01-15Patent 11648262Patent 10912795 — 2039-01-15Patent 10912795Patent 11642370 — 2039-01-15Patent 11642370Patent 11510941 — 2039-01-15Patent 11510941Patent 10543186 — 2039-03-15Patent 10543186Patent 11045438 — 2039-03-15Patent 11045438Patent 10493051 — 2039-03-15Patent 10493051Patent 10702490 — 2039-03-15Patent 10702490
Patent expiryExclusivity endToday
Orange Book patent file

Listed patents

Listed patents (20)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11510942Jan 15, 2039in 12 yr 8 mo
ProductU-2752
11969439Jan 15, 2039in 12 yr 8 mo
U-2752
10478453Jan 15, 2039in 12 yr 8 mo
ProductU-2752
10583155Jan 15, 2039in 12 yr 8 mo
ProductU-2752
10653719Jan 15, 2039in 12 yr 8 mo
Product
10918662Jan 15, 2039in 12 yr 8 mo
Product
10905713Jan 15, 2039in 12 yr 8 mo
Product
10905714Jan 15, 2039in 12 yr 8 mo
Product
11684636Jan 15, 2039in 12 yr 8 mo
Product
10933089Jan 15, 2039in 12 yr 8 mo
Product
11826383Jan 15, 2039in 12 yr 8 mo
Product
11679125Jan 15, 2039in 12 yr 8 mo
Product
11648262Jan 15, 2039in 12 yr 8 mo
Product
10912795Jan 15, 2039in 12 yr 8 mo
Product
11642370Jan 15, 2039in 12 yr 8 mo
Product
11510941Jan 15, 2039in 12 yr 8 mo
Product
10543186Mar 15, 2039in 12 yr 10 mo
U-2722
11045438Mar 15, 2039in 12 yr 10 mo
Product
10493051Mar 15, 2039in 12 yr 10 mo
Product
10702490Mar 15, 2039in 12 yr 10 mo
Product
FDA approval span

Approval history

First approval
Oct 22, 1986
40 yr 4 mo ago
Most recent approval
Dec 04, 2023
2 yr 8 mo ago

Approvals span 1986–2023 across 3 FDA applications.

Brand (NDA) 3100%
Generic (ANDA) 00%

Cysteine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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