FDA Orange Book
Generic for Acetadote
Acetadote contains acetylcysteine. 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
Yes. The generic name for Acetadote is acetylcysteine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Acetadote products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | 6GM/30ML (200MG/ML) | Marketed (Rx) | AP | 9 | AP |
NDA 021539, held by APOTEX INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic acetylcysteine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 200644 | AP (A-rated, therapeutically equivalent) | November 7, 2012 | 6GM/30ML (200MG/ML) |
| RISING PHARMA HOLDINGS INC | 203173 | AP (A-rated, therapeutically equivalent) | March 24, 2015 | 6GM/30ML (200MG/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 207358 | AP (A-rated, therapeutically equivalent) | February 29, 2016 | 6GM/30ML (200MG/ML) |
| SAGENT PHARMACEUTICALS INC | 091684 | AP (A-rated, therapeutically equivalent) | October 31, 2017 | 6GM/30ML (200MG/ML) |
| ZYDUS PHARMACEUTICALS USA INC | 208166 | AP (A-rated, therapeutically equivalent) | July 20, 2018 | 6GM/30ML (200MG/ML) |
| GLENMARK PHARMACEUTICALS INC USA | 213693 | AP (A-rated, therapeutically equivalent) | February 3, 2022 | 6GM/30ML (200MG/ML) |
| REGCON HOLDINGS LLC | 215620 | AP (A-rated, therapeutically equivalent) | February 23, 2022 | 6GM/30ML (200MG/ML) |
| ONESOURCE SPECIALTY PTE LTD | 217182 | AP (A-rated, therapeutically equivalent) | April 19, 2023 | 6GM/30ML (200MG/ML) |
| SOMERSET THERAPEUTICS LLC | 218397 | AP (A-rated, therapeutically equivalent) | June 7, 2024 | 6GM/30ML (200MG/ML) |
Acetadote patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8148356 | May 21, 2026 | Drug product | None | 021539 |
| 9327028 | July 21, 2031 | Method of use | U-1839 | 021539 |
| 8722738 | April 6, 2032 | Method of use | U-1373 | 021539 |
Acetadote exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| D-196 | New dosing schedule | November 26, 2027 | 021539 |
Acetadote NDC codes
Questions
Is there a generic for Acetadote?
Yes. The generic name for Acetadote is acetylcysteine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Acetadote?
The active ingredient in Acetadote is acetylcysteine, per the FDA Orange Book.
When does the Acetadote patent expire?
The last patent listed for Acetadote in the Orange Book expires April 6, 2032. 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.