FDA Orange Book
Generic for Precedex
Precedex contains dexmedetomidine. 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 Precedex is dexmedetomidine. 22 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Precedex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) | Marketed (Rx) | AP | 1 | AP |
| injectable, injection | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | Marketed (Rx) | AP | 13 | AP |
| injectable, injection | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | Marketed (Rx) | AP | 14 | AP |
| injectable, injection | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | Marketed (Rx) | AP | 14 | AP |
| injectable, injection | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | Marketed (Rx) | AP | 3 | AP |
NDA 021038, held by HOSPIRA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dexmedetomidine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN INSTITUTIONAL LLC | 202881 | AP (A-rated, therapeutically equivalent) | August 18, 2014 | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) |
| PH HEALTH LTD | 203972 | AP (A-rated, therapeutically equivalent) | August 18, 2014 | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) |
| RISING PHARMA HOLDINGS INC | 202585 | AP (A-rated, therapeutically equivalent) | November 24, 2014 | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) |
| GLAND PHARMA LTD | 202126 | AP (A-rated, therapeutically equivalent) | August 20, 2015 | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) |
| FRESENIUS KABI USA LLC | 201072 | AP (A-rated, therapeutically equivalent) | September 18, 2015 | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) |
| ACCORD HEALTHCARE INC | 204023 | AP (A-rated, therapeutically equivalent) | February 9, 2016 | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 205867 | AP (A-rated, therapeutically equivalent) | March 17, 2016 | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) |
| ACTAVIS INC | 204686 | AP (A-rated, therapeutically equivalent) | October 17, 2016 | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) |
| HIKMA PHARMACEUTICALS USA INC | 205046 | AP (A-rated, therapeutically equivalent) | April 26, 2017 | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) |
| TEVA PHARMACEUTICALS USA | 205272 | AP (A-rated, therapeutically equivalent) | November 28, 2017 | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) |
| ZYDUS PHARMACEUTICALS USA INC | 206798 | AP (A-rated, therapeutically equivalent) | February 27, 2018 | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) |
| BAXTER HEALTHCARE CORP | 208532 | AP (A-rated, therapeutically equivalent) | August 21, 2018 | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) |
| FRESENIUS KABI USA LLC | 208129 | AP (A-rated, therapeutically equivalent) | November 29, 2018 | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML), EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) |
| MEITHEAL PHARMACEUTICALS INC | 204843 | AP (A-rated, therapeutically equivalent) | January 18, 2019 | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) |
| WILSHIRE PHARMACEUTICALS INC | 212791 | AP (A-rated, therapeutically equivalent) | December 4, 2019 | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) |
| AMNEAL PHARMACEUTICALS CO GMBH | 207551 | AP (A-rated, therapeutically equivalent) | May 20, 2020 | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) |
| GLAND PHARMA LTD | 209307 | AP (A-rated, therapeutically equivalent) | June 3, 2020 | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) |
| JIANGSU HENGRUI PHARMACEUTICALS CO LTD | 209065 | AP (A-rated, therapeutically equivalent) | June 12, 2020 | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML), EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) |
| MYLAN LABORATORIES LTD | 212571 | AP (A-rated, therapeutically equivalent) | August 27, 2020 | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) |
| PH HEALTH LTD | 208266 | AP (A-rated, therapeutically equivalent) | September 15, 2020 | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) |
| TAGI PHARMA INC | 212857 | AP (A-rated, therapeutically equivalent) | November 23, 2020 | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML), EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 210321 | AP (A-rated, therapeutically equivalent) | December 7, 2020 | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) |
| AMNEAL EU LTD | 216604 | AP (A-rated, therapeutically equivalent) | May 15, 2023 | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) |
| MILLA PHARMACEUTICALS INC | 217308 | AP (A-rated, therapeutically equivalent) | June 7, 2023 | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) |
| HIKMA PHARMACEUTICALS USA INC | 206407 | AP (A-rated, therapeutically equivalent) | May 30, 2025 | EQ 1MG BASE/250ML (EQ 4MCG BASE/ML), EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) |
| DR REDDYS LABORATORIES LTD | 220315 | AP (A-rated, therapeutically equivalent) | February 25, 2026 | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) |
| NEPHRON PHARMACEUTICALS CORPORATION | 216254 | AP (A-rated, therapeutically equivalent) | September 28, 2026 | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) |
Precedex patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8455527 | January 4, 2032 | Method of use | U-421 | 021038 |
| 9616049 | January 4, 2032 | Drug product | None | 021038 |
| 8242158 | January 4, 2032 | Drug product | None | 021038 |
| 8338470 | January 4, 2032 | Drug product | None | 021038 |
| 9320712 | January 4, 2032 | Drug product | None | 021038 |
| 8648106 | January 4, 2032 | Drug product | None | 021038 |
| 10016396 | January 4, 2032 | Drug product | None | 021038 |
| 8648106*PED | July 4, 2032 | Method of use | None | 021038 |
| 8242158*PED | July 4, 2032 | Method of use | None | 021038 |
| 8455527*PED | July 4, 2032 | Method of use | None | 021038 |
| 8338470*PED | July 4, 2032 | Method of use | None | 021038 |
| 9320712*PED | July 4, 2032 | Method of use | None | 021038 |
| 9616049*PED | July 4, 2032 | Method of use | None | 021038 |
Precedex NDC codes
Questions
Is there a generic for Precedex?
Yes. The generic name for Precedex is dexmedetomidine. 22 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Precedex?
The active ingredient in Precedex is dexmedetomidine, per the FDA Orange Book.
When does the Precedex patent expire?
The last patent listed for Precedex in the Orange Book expires July 4, 2032. 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.