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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
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  • 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
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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
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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
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First approval
40 yr 7 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.

Related FDA reference tools

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