FDA Orange Book
Generic for Amitiza
Amitiza contains lubiprostone. 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 Amitiza is lubiprostone. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Amitiza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 24MCG | Marketed (Rx) | AB | 5 | AB |
| capsule, oral | 8MCG | Marketed (Rx) | AB | 5 | AB |
NDA 021908, held by SUCAMPO PHARMA AMERICAS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lubiprostone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL PHARMACEUTICALS LLC | 209450 | AB (A-rated, therapeutically equivalent) | November 30, 2021 | 24MCG, 8MCG |
| TEVA PHARMACEUTICALS USA INC | 209920 | AB (A-rated, therapeutically equivalent) | January 18, 2022 | 24MCG, 8MCG |
| DR REDDYS LABORATORIES LTD | 206994 | AB (A-rated, therapeutically equivalent) | February 8, 2022 | 24MCG, 8MCG |
| ZYDUS PHARMACEUTICALS USA INC | 214131 | AB (A-rated, therapeutically equivalent) | March 23, 2023 | 24MCG, 8MCG |
| ASCENT PHARMACEUTICALS INC | 218640 | AB (A-rated, therapeutically equivalent) | January 2, 2025 | 24MCG, 8MCG |
Amitiza patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8779187 | January 23, 2027 | Drug product | None | 021908 |
| 8338639 | January 23, 2027 | Drug product | None | 021908 |
| 8026393 | October 25, 2027 | Drug product | None | 021908 |
Amitiza NDC codes
Questions
Is there a generic for Amitiza?
Yes. The generic name for Amitiza is lubiprostone. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Amitiza?
The active ingredient in Amitiza is lubiprostone, per the FDA Orange Book.
When does the Amitiza patent expire?
The last patent listed for Amitiza in the Orange Book expires October 25, 2027. 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.