FDA Orange Book
Is there a generic for Elcys?
Elcys contains cysteine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Elcys (cysteine). The Orange Book shows its last listed patent expires January 15, 2039.
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Elcys products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 2500MG/50ML (50MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 500MG/10ML (50MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 210660, held by EXELA PHARMA SCIENCES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Elcys patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11510942 | January 15, 2039 | Drug product | U-2752 | 210660 |
| 11969439 | January 15, 2039 | Method of use | U-2752 | 210660 |
| 10478453 | January 15, 2039 | Drug product | U-2752 | 210660 |
| 10583155 | January 15, 2039 | Drug product | U-2752 | 210660 |
| 10653719 | January 15, 2039 | Drug product | None | 210660 |
| 10918662 | January 15, 2039 | Drug product | None | 210660 |
| 10905713 | January 15, 2039 | Drug product | None | 210660 |
| 10905714 | January 15, 2039 | Drug product | None | 210660 |
| 11684636 | January 15, 2039 | Drug product | None | 210660 |
| 10933089 | January 15, 2039 | Drug product | None | 210660 |
| 11826383 | January 15, 2039 | Drug product | None | 210660 |
| 11679125 | January 15, 2039 | Drug product | None | 210660 |
| 11648262 | January 15, 2039 | Drug product | None | 210660 |
| 10912795 | January 15, 2039 | Drug product | None | 210660 |
| 11642370 | January 15, 2039 | Drug product | None | 210660 |
| 11510941 | January 15, 2039 | Drug product | None | 210660 |
Elcys NDC codes
Questions
Is there a generic for Elcys?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Elcys (cysteine). The Orange Book shows its last listed patent expires January 15, 2039.
What is the generic name for Elcys?
The active ingredient in Elcys is cysteine, per the FDA Orange Book.
When does the Elcys patent expire?
The last patent listed for Elcys in the Orange Book expires January 15, 2039. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.