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Generic competition · all medicines · read 12 November 2026

Is there a generic of Cysteine Hydrochloride, and who makes it?

Cysteine Hydrochloride appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Cysteine Hydrochloride2 dosage-form groups in the Orange Book
0generic makers listed
  1. Cysteine Hydrochloride appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
  2. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Solution, Intravenous

Brand listed, no generic listed as marketed

Brand listed as marketed: Elcys and Nouress. No generic is listed as marketed.

20152020202520302035204001brand 2019data datePatent 11510942 listed to expire 15 January 2039Patent 11969439 listed to expire 15 January 2039Patent 10478453 listed to expire 15 January 2039Patent 10583155 listed to expire 15 January 2039Patent 10653719 listed to expire 15 January 2039Patent 10918662 listed to expire 15 January 2039Patent 10905713 listed to expire 15 January 2039Patent 10905714 listed to expire 15 January 2039Patent 11684636 listed to expire 15 January 2039Patent 10933089 listed to expire 15 January 2039Patent 11826383 listed to expire 15 January 2039Patent 11679125 listed to expire 15 January 2039Patent 11648262 listed to expire 15 January 2039Patent 10912795 listed to expire 15 January 2039Patent 11642370 listed to expire 15 January 2039Patent 11510941 listed to expire 15 January 2039Patent 12569514 listed to expire 15 January 2039Patent 10543186 listed to expire 15 March 2039Patent 11045438 listed to expire 15 March 2039Patent 10493051 listed to expire 15 March 2039Patent 10702490 listed to expire 15 March 2039
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 15 January 2039Patent 11510942 drug product
  • 15 January 2039Patent 11969439
  • 15 January 2039Patent 10478453 drug product
  • 15 January 2039Patent 10583155 drug product
  • 15 January 2039Patent 10653719 drug product
  • 15 January 2039Patent 10918662 drug product
  • 15 January 2039Patent 10905713 drug product
  • 15 January 2039Patent 10905714 drug product

13 more patents are listed.

Injectable, Injection

Nothing listed as marketed

Every brand product here is listed as discontinued. No generic is listed as marketed.

198519901995200020052010201520202025203001brand 1986data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.