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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
Brands (NDA)
3
Generics (ANDA)
0
Listed patents
21
Next patent expiry
Jan 15, 2039
in 12 yr 5 mo

Brand (NDA) products

Originator applications
  • 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)SOLUTIONINTRAVENOUSRx—
  • CYSTEINE HYDROCHLORIDERLD
    NDA 0195231986
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.25%INJECTABLEINJECTIONDiscontinued—

Patent & exclusivity timeline

Protection horizon
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 12569514: 2039-01-15Patent 12569514Patent 10543186: 2039-03-15Patent 10543186Patent 11045438: 2039-03-15Patent 11045438Patent 10493051: 2039-03-15Patent 10493051Patent 10702490: 2039-03-15Patent 10702490
Patent expiryExclusivity endToday

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11510942in 12 yr 5 mo
ProductU-2752
11969439in 12 yr 5 mo
U-2752
10478453in 12 yr 5 mo
ProductU-2752
10583155in 12 yr 5 mo
ProductU-2752
10653719in 12 yr 5 mo
Product
10918662in 12 yr 5 mo
Product
10905713in 12 yr 5 mo
Product
10905714in 12 yr 5 mo
Product
11684636in 12 yr 5 mo
Product
10933089in 12 yr 5 mo
Product
11826383in 12 yr 5 mo
Product
11679125in 12 yr 5 mo
Product
11648262in 12 yr 5 mo
Product
10912795in 12 yr 5 mo
Product
11642370in 12 yr 5 mo
Product
11510941in 12 yr 5 mo
Product
12569514in 12 yr 5 mo
Product
10543186in 12 yr 7 mo
U-2722
11045438in 12 yr 7 mo
Product
10493051in 12 yr 7 mo
Product
10702490in 12 yr 7 mo
Product

Approval history

FDA approval span
First approval
40 yr 6 mo ago
Most recent approval
2 yr 11 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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