FDA Orange Book
Generic for Naropin
Naropin contains ropivacaine. 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 Naropin is ropivacaine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 11 of the 13 Naropin products the Orange Book lists.
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Naropin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, injection | 100MG/10ML (10MG/ML) | Marketed (Rx) | AP | 3 | AP |
| solution, injection | 100MG/20ML (5MG/ML) | Marketed (Rx) | AP | 5 | AP |
| solution, injection | 150MG/20ML (7.5MG/ML) | Marketed (Rx) | AP | 4 | AP |
| solution, injection | 150MG/30ML (5MG/ML) | Marketed (Rx) | AP | 8 | AP |
| solution, injection | 1GM/200ML (5MG/ML) | Marketed (Rx) | AP | 2 | AP |
| solution, injection | 200MG/100ML (2MG/ML) | Marketed (Rx) | AP | 8 | AP |
| solution, injection | 200MG/20ML (10MG/ML) | Marketed (Rx) | AP | 7 | AP |
| solution, injection | 20MG/10ML (2MG/ML) | Marketed (Rx) | AP | 3 | AP |
| solution, injection | 400MG/200ML (2MG/ML) | Marketed (Rx) | AP | 7 | AP |
| solution, injection | 40MG/20ML (2MG/ML) | Marketed (Rx) | AP | 6 | AP |
| solution, injection | 500MG/100ML (5MG/ML) | Marketed (Rx) | AP | 3 | AP |
| solution, injection | 50MG/10ML (5MG/ML) | Discontinued | None | 0 | None |
| solution, injection | 75MG/10ML (7.5MG/ML) | Discontinued | None | 0 | None |
NDA 020533, held by FRESENIUS KABI USA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ropivacaine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NAVINTA LLC | 078601 | AP (A-rated, therapeutically equivalent) | July 17, 2014 | 150MG/30ML (5MG/ML), 200MG/20ML (10MG/ML) |
| RISING PHARMA HOLDINGS INC | 203955 | AP (A-rated, therapeutically equivalent) | April 11, 2016 | 150MG/30ML (5MG/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 205612 | AP (A-rated, therapeutically equivalent) | July 13, 2016 | 100MG/10ML (10MG/ML), 100MG/20ML (5MG/ML), 150MG/20ML (7.5MG/ML), 150MG/30ML (5MG/ML), 200MG/100ML (2MG/ML), 200MG/20ML (10MG/ML), 40MG/20ML (2MG/ML) |
| RISING PHARMA HOLDINGS INC | 204636 | AP (A-rated, therapeutically equivalent) | March 16, 2018 | 200MG/100ML (2MG/ML), 400MG/200ML (2MG/ML) |
| INFORLIFE SA | 206166 | AP (A-rated, therapeutically equivalent) | June 11, 2018 | 1GM/200ML (5MG/ML), 200MG/100ML (2MG/ML), 400MG/200ML (2MG/ML), 500MG/100ML (5MG/ML) |
| SOMERSET THERAPEUTICS LLC | 207636 | AP (A-rated, therapeutically equivalent) | June 15, 2018 | 100MG/10ML (10MG/ML), 100MG/20ML (5MG/ML), 150MG/20ML (7.5MG/ML), 150MG/30ML (5MG/ML), 200MG/20ML (10MG/ML), 20MG/10ML (2MG/ML), 40MG/20ML (2MG/ML) |
| CAPLIN STERILES LTD | 212808 | AP (A-rated, therapeutically equivalent) | April 9, 2020 | 100MG/20ML (5MG/ML), 150MG/30ML (5MG/ML), 200MG/100ML (2MG/ML), 200MG/20ML (10MG/ML), 400MG/200ML (2MG/ML), 40MG/20ML (2MG/ML) |
| HIKMA PHARMACEUTICALS USA INC | 214074 | AP (A-rated, therapeutically equivalent) | July 20, 2020 | 150MG/20ML (7.5MG/ML), 150MG/30ML (5MG/ML), 200MG/20ML (10MG/ML), 40MG/20ML (2MG/ML) |
| GLAND PHARMA LTD | 210102 | AP (A-rated, therapeutically equivalent) | August 18, 2022 | 200MG/100ML (2MG/ML), 400MG/200ML (2MG/ML) |
| AMNEAL EU LTD | 216605 | AP (A-rated, therapeutically equivalent) | March 7, 2023 | 1GM/200ML (5MG/ML), 200MG/100ML (2MG/ML), 400MG/200ML (2MG/ML), 500MG/100ML (5MG/ML) |
| MYLAN LABORATORIES LTD | 206091 | AP (A-rated, therapeutically equivalent) | October 26, 2023 | 200MG/100ML (2MG/ML), 400MG/200ML (2MG/ML) |
| KINDOS PHARMACEUTICALS CO LTD | 218713 | AP (A-rated, therapeutically equivalent) | July 30, 2024 | 100MG/10ML (10MG/ML), 100MG/20ML (5MG/ML), 150MG/20ML (7.5MG/ML), 150MG/30ML (5MG/ML), 200MG/20ML (10MG/ML), 20MG/10ML (2MG/ML), 40MG/20ML (2MG/ML) |
| HIKMA PHARMACEUTICALS USA INC | 211907 | AP (A-rated, therapeutically equivalent) | August 15, 2024 | 200MG/100ML (2MG/ML), 400MG/200ML (2MG/ML), 500MG/100ML (5MG/ML) |
| ADAPTIS PHARMA PRIVATE LTD | 219883 | AP (A-rated, therapeutically equivalent) | October 8, 2025 | 100MG/20ML (5MG/ML), 150MG/30ML (5MG/ML), 200MG/20ML (10MG/ML), 20MG/10ML (2MG/ML), 40MG/20ML (2MG/ML) |
Naropin patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7857802 | November 28, 2026 | Drug product | None | 020533 |
Naropin NDC codes
Questions
Is there a generic for Naropin?
Yes. The generic name for Naropin is ropivacaine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 11 of the 13 Naropin products the Orange Book lists.
What is the generic name for Naropin?
The active ingredient in Naropin is ropivacaine, per the FDA Orange Book.
When does the Naropin patent expire?
The last patent listed for Naropin in the Orange Book expires November 28, 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.