FDA Orange Book
Generic for Nexterone
Nexterone contains amiodarone. 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 Nexterone is amiodarone. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 3 Nexterone products the Orange Book lists.
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Nexterone products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 150MG/100ML (1.5MG/ML) | Marketed (Rx) | None | 0 | None |
| injectable, injection | 360MG/200ML (1.8MG/ML) | Marketed (Rx) | None | 0 | None |
| injectable, injection | 50MG/ML | Discontinued | None | 7 | AP |
NDA 022325, held by BAXTER HEALTHCARE CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic amiodarone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 075761 | AP (A-rated, therapeutically equivalent) | October 15, 2002 | 50MG/ML |
| MYLAN INSTITUTIONAL LLC | 076217 | AP (A-rated, therapeutically equivalent) | October 15, 2002 | 50MG/ML |
| GLAND PHARMA LTD | 077161 | AP (A-rated, therapeutically equivalent) | April 20, 2005 | 50MG/ML |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 077234 | AP (A-rated, therapeutically equivalent) | February 25, 2008 | 50MG/ML |
| ACELLA PHARMACEUTICALS LLC | 077610 | AP (A-rated, therapeutically equivalent) | October 30, 2008 | 50MG/ML |
| ACELLA PHARMACEUTICALS LLC | 077834 | AP (A-rated, therapeutically equivalent) | October 30, 2008 | 50MG/ML |
| ZHEJIANG POLY PHARM CO LTD | 218253 | AP (A-rated, therapeutically equivalent) | September 11, 2024 | 50MG/ML |
Nexterone patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7635773 | March 13, 2029 | Drug product | None | 022325 |
| 8410077 | March 13, 2029 | Drug product | None | 022325 |
| 10117951 | March 13, 2029 | Drug product | None | 022325 |
| 9200088 | March 13, 2029 | Drug product | None | 022325 |
| 9750822 | March 13, 2029 | Drug product | None | 022325 |
| 9493582 | February 27, 2033 | Drug product | None | 022325 |
Nexterone NDC codes
Questions
Is there a generic for Nexterone?
Yes. The generic name for Nexterone is amiodarone. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 3 Nexterone products the Orange Book lists.
What is the generic name for Nexterone?
The active ingredient in Nexterone is amiodarone, per the FDA Orange Book.
When does the Nexterone patent expire?
The last patent listed for Nexterone in the Orange Book expires February 27, 2033. 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.