FDA Orange Book
Generic for Drizalma Sprinkle
Drizalma Sprinkle contains duloxetine. 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 Drizalma Sprinkle is duloxetine. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Drizalma Sprinkle products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, delayed rel pellets, oral | EQ 20MG BASE | Marketed (Rx) | None | 16 | AB |
| capsule, delayed rel pellets, oral | EQ 30MG BASE | Marketed (Rx) | None | 16 | AB |
| capsule, delayed rel pellets, oral | EQ 40MG BASE | Marketed (Rx) | None | 4 | AB |
| capsule, delayed rel pellets, oral | EQ 60MG BASE | Marketed (Rx) | None | 16 | AB |
NDA 212516, held by SUN PHARMACEUTICAL INDUSTRIES LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic duloxetine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 090778 | AB (A-rated, therapeutically equivalent) | December 11, 2013 | EQ 20MG BASE, EQ 30MG BASE, EQ 60MG BASE |
| LUPIN LTD | 090694 | AB (A-rated, therapeutically equivalent) | December 11, 2013 | EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE, EQ 60MG BASE |
| ACTAVIS ELIZABETH LLC | 090776 | AB (A-rated, therapeutically equivalent) | December 17, 2013 | EQ 20MG BASE, EQ 30MG BASE, EQ 60MG BASE |
| ZYDUS HEALTHCARE USA LLC | 090739 | AB (A-rated, therapeutically equivalent) | January 8, 2014 | EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE, EQ 60MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 090728 | AB (A-rated, therapeutically equivalent) | January 8, 2014 | EQ 20MG BASE, EQ 30MG BASE, EQ 60MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 202949 | AB (A-rated, therapeutically equivalent) | June 9, 2014 | EQ 20MG BASE, EQ 30MG BASE, EQ 60MG BASE |
| BRECKENRIDGE PHARMACEUTICAL INC | 203088 | AB (A-rated, therapeutically equivalent) | June 11, 2014 | EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE, EQ 60MG BASE |
| ALKEM LABORATORIES LTD | 203197 | AB (A-rated, therapeutically equivalent) | August 26, 2015 | EQ 20MG BASE, EQ 30MG BASE, EQ 60MG BASE |
| INVENTIA HEALTHCARE LTD | 202336 | AB (A-rated, therapeutically equivalent) | October 28, 2015 | EQ 20MG BASE, EQ 30MG BASE, EQ 60MG BASE |
| HETERO LABS LTD UNIT III | 204343 | AB (A-rated, therapeutically equivalent) | August 3, 2016 | EQ 20MG BASE, EQ 30MG BASE, EQ 60MG BASE |
| AJANTA PHARMA LTD | 208706 | AB (A-rated, therapeutically equivalent) | January 6, 2017 | EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE, EQ 60MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 204815 | AB (A-rated, therapeutically equivalent) | March 23, 2017 | EQ 20MG BASE, EQ 30MG BASE, EQ 60MG BASE |
| PRINSTON PHARMACEUTICAL INC | 206653 | AB (A-rated, therapeutically equivalent) | May 18, 2017 | EQ 20MG BASE, EQ 30MG BASE, EQ 60MG BASE |
| CSPC OUYI PHARMACEUTICAL CO LTD | 211310 | AB (A-rated, therapeutically equivalent) | October 16, 2018 | EQ 20MG BASE, EQ 30MG BASE, EQ 60MG BASE |
| QINGDAO BAHEAL PHARMACEUTICAL CO LTD | 210599 | AB (A-rated, therapeutically equivalent) | April 17, 2019 | EQ 20MG BASE, EQ 30MG BASE, EQ 60MG BASE |
| SUNSHINE LAKE PHARMA CO LTD | 212328 | AB (A-rated, therapeutically equivalent) | February 11, 2021 | EQ 20MG BASE, EQ 30MG BASE, EQ 60MG BASE |
Drizalma Sprinkle patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9839626 | April 13, 2037 | Drug product | None | 212516 |
| 10413525 | April 13, 2037 | Drug product | None | 212516 |
| 12171742 | April 13, 2037 | Drug product | None | 212516 |
| 11202772 | April 13, 2037 | Drug product | None | 212516 |
| 10959982 | April 13, 2037 | Drug product | None | 212516 |
Drizalma Sprinkle NDC codes
Questions
Is there a generic for Drizalma Sprinkle?
Yes. The generic name for Drizalma Sprinkle is duloxetine. 16 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 Drizalma Sprinkle?
The active ingredient in Drizalma Sprinkle is duloxetine, per the FDA Orange Book.
When does the Drizalma Sprinkle patent expire?
The last patent listed for Drizalma Sprinkle in the Orange Book expires April 13, 2037. 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.
More on Drizalma Sprinkle and Duloxetine
- What is Duloxetine used for?FDA label uses
- Is Duloxetine a controlled substance?Federal schedule
- Generic for CymbaltaFDA Orange Book
- Serotonin and Norepinephrine Reuptake Inhibitors listFDA drug class
- Drizalma Sprinkle Medicare Part D coverageBy plan and state
- NDC 47335-616Drizalma Sprinkle NDC record
- NDC 47335-617Drizalma Sprinkle NDC record
- NDC 47335-618Drizalma Sprinkle NDC record