FDA Orange Book
Is there a generic for Arikayce Kit?
Arikayce Kit contains amikacin. 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 Arikayce Kit (amikacin). The Orange Book shows its last listed patent expires May 15, 2035 and its last listed exclusivity ends September 28, 2030.
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Arikayce Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, liposomal, inhalation | EQ 590MG BASE/8.4ML | Marketed (Rx) | None | 0 | None |
NDA 207356, held by INSMED INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Arikayce Kit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8679532 | December 5, 2026 | Method of use | U-2415 | 207356 |
| 8632804 | December 5, 2026 | Method of use | U-2416 | 207356 |
| 8642075 | December 5, 2026 | Drug product | None | 207356 |
| 8226975 | August 15, 2028 | Drug product | None | 207356 |
| 9566234 | January 18, 2034 | Drug product | U-2415 | 207356 |
| 10251900 | May 15, 2035 | Method of use | U-2414 | 207356 |
| 12377114 | May 15, 2035 | Method of use | U-2414 | 207356 |
| 9895385 | May 15, 2035 | Method of use | U-2417 | 207356 |
| 12016873 | May 15, 2035 | Method of use | U-2414 | 207356 |
| 10751355 | May 15, 2035 | Method of use | U-2414 | 207356 |
| 11446318 | May 15, 2035 | Method of use | U-2414 | 207356 |
| 12168022 | May 15, 2035 | Method of use | U-2414 | 207356 |
| 12168021 | May 15, 2035 | Method of use | U-2414 | 207356 |
| 12616708 | May 15, 2035 | Method of use | U-2414 | 207356 |
Arikayce Kit exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-214 | Orphan drug exclusivity | September 28, 2025 | 207356 |
| GAIN | Generating Antibiotic Incentives Now | September 28, 2030 | 207356 |
Arikayce Kit NDC codes
Questions
Is there a generic for Arikayce Kit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Arikayce Kit (amikacin). The Orange Book shows its last listed patent expires May 15, 2035 and its last listed exclusivity ends September 28, 2030.
What is the generic name for Arikayce Kit?
The active ingredient in Arikayce Kit is amikacin, per the FDA Orange Book.
When does the Arikayce Kit patent expire?
The last patent listed for Arikayce Kit in the Orange Book expires May 15, 2035. 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.