FDA Orange Book
Generic for Arymo ER
Arymo ER contains morphine. 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 Arymo ER is morphine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Arymo ER products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 15MG | Discontinued | None | 4 | AB |
| tablet, extended release, oral | 30MG | Discontinued | None | 3 | AB |
| tablet, extended release, oral | 60MG | Discontinued | None | 3 | AB |
NDA 208603, held by ZYLA LIFE SCIENCES US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic morphine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RHODES PHARMACEUTICALS LP | 074862 | AB (A-rated, therapeutically equivalent) | July 7, 1998 | 15MG, 30MG, 60MG |
| DAVA PHARMACEUTICALS INC | 075407 | AB (A-rated, therapeutically equivalent) | January 28, 2000 | 15MG |
| SPECGX LLC | 076412 | AB (A-rated, therapeutically equivalent) | July 31, 2003 | 15MG, 30MG, 60MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 078761 | AB (A-rated, therapeutically equivalent) | May 11, 2012 | 15MG, 30MG, 60MG |
Arymo ER patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9549899 | July 1, 2033 | Drug product | U-1556 | 208603 |
| 9044402 | July 1, 2033 | Drug product | U-1556 | 208603 |
Questions
Is there a generic for Arymo ER?
Yes. The generic name for Arymo ER is morphine. 4 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 Arymo ER?
The active ingredient in Arymo ER is morphine, per the FDA Orange Book.
When does the Arymo ER patent expire?
The last patent listed for Arymo ER in the Orange Book expires July 1, 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.