FDA Orange Book
Generic for Bridion
Bridion contains sugammadex. 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 Bridion is sugammadex. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Bridion products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | Marketed (Rx) | AP | 20 | AP |
| solution, intravenous | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | Marketed (Rx) | AP | 17 | AP |
NDA 022225, held by MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sugammadex
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ASPIRO PHARMA LTD | 214337 | AP (A-rated, therapeutically equivalent) | June 9, 2023 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| ZYDUS PHARMACEUTICALS USA INC | 214290 | AP (A-rated, therapeutically equivalent) | October 4, 2023 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| B BRAUN MEDICAL INC | 214279 | AP (A-rated, therapeutically equivalent) | August 5, 2025 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) |
| DR REDDYS LABORATORIES LTD | 214236 | AP (A-rated, therapeutically equivalent) | July 28, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| FRESENIUS KABI USA LLC | 219448 | AP (A-rated, therapeutically equivalent) | July 28, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) |
| GLAND PHARMA LTD | 214364 | AP (A-rated, therapeutically equivalent) | July 28, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| HIKMA PHARMACEUTICALS USA INC | 218727 | AP (A-rated, therapeutically equivalent) | July 28, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) |
| HIKMA PHARMACEUTICALS USA INC | 218728 | AP (A-rated, therapeutically equivalent) | July 28, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| LUPIN LTD | 214338 | AP (A-rated, therapeutically equivalent) | July 28, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| MANKIND PHARMA LTD | 214230 | AP (A-rated, therapeutically equivalent) | July 28, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| MSN LABORATORIES PRIVATE LTD | 214368 | AP (A-rated, therapeutically equivalent) | July 28, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| MYLAN PHARMACEUTICALS INC | 213915 | AP (A-rated, therapeutically equivalent) | July 28, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| QILU PHARMACEUTICAL HAINAN CO LTD | 215575 | AP (A-rated, therapeutically equivalent) | July 28, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| SANDOZ INC | 214311 | AP (A-rated, therapeutically equivalent) | July 28, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| STERISCIENCE PTE LTD | 218814 | AP (A-rated, therapeutically equivalent) | July 28, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| SUN PHARMACEUTICAL INDUSTRIES INC | 214319 | AP (A-rated, therapeutically equivalent) | July 28, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| TAMARANG SA | 215260 | AP (A-rated, therapeutically equivalent) | July 28, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| TEVA PHARMACEUTICALS USA INC | 214126 | AP (A-rated, therapeutically equivalent) | July 28, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| ZENARA PHARMA PRIVATE LTD | 214306 | AP (A-rated, therapeutically equivalent) | July 28, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| SHANDONG NEW TIME PHARMACEUTICAL CO LTD | 215701 | AP (A-rated, therapeutically equivalent) | October 6, 2026 | EQ 200MG BASE/2ML (EQ 100MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
Bridion patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE44733 | January 27, 2026 | Drug substance, Drug product | U-1794 | 022225 |
| RE44733*PED | July 27, 2026 | Method of use | None | 022225 |
Bridion exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | December 12, 2027 | 022225 |
| PED | Pediatric exclusivity | June 12, 2028 | 022225 |
Bridion NDC codes
Questions
Is there a generic for Bridion?
Yes. The generic name for Bridion is sugammadex. 19 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 Bridion?
The active ingredient in Bridion is sugammadex, per the FDA Orange Book.
When does the Bridion patent expire?
The last patent listed for Bridion in the Orange Book expires July 27, 2026. 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.