FDA Orange Book
Generic for Morphabond ER
Morphabond 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 Morphabond 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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Morphabond ER products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 100MG | Discontinued | None | 3 | AB |
| 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 206544, held by OHEMO LIFE SCIENCES 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 | 074769 | AB (A-rated, therapeutically equivalent) | July 2, 1998 | 100MG |
| 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 | 076438 | AB (A-rated, therapeutically equivalent) | July 3, 2003 | 100MG |
| 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 | 100MG, 15MG, 30MG, 60MG |
Morphabond ER patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10314788 | August 12, 2028 | Drug product | None | 206544 |
| 7955619 | August 12, 2028 | Drug product | None | 206544 |
Questions
Is there a generic for Morphabond ER?
Yes. The generic name for Morphabond 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 Morphabond ER?
The active ingredient in Morphabond ER is morphine, per the FDA Orange Book.
When does the Morphabond ER patent expire?
The last patent listed for Morphabond ER in the Orange Book expires August 12, 2028. 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.