FDA Orange Book · active-ingredient family
Ropivacaine hydrochloride
Ropivacaine hydrochloride: 1 brand, 16 generics; first approved Sep 24, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
16
Listed patents
1
Next patent expiry
Nov 28, 2026
in 3 mo
Brand (NDA) products
Originator applications
- NAROPINRLDFRESENIUS KABI USANDA 020533201113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/10ML (2MG/ML) SOLUTION INJECTION Rx AP 40MG/20ML (2MG/ML) SOLUTION INJECTION Rx AP 100MG/20ML (5MG/ML) SOLUTION INJECTION Rx AP 150MG/20ML (7.5MG/ML) SOLUTION INJECTION Rx AP 100MG/10ML (10MG/ML) SOLUTION INJECTION Rx AP 200MG/100ML (2MG/ML) SOLUTION INJECTION Rx AP 400MG/200ML (2MG/ML) SOLUTION INJECTION Rx AP 150MG/30ML (5MG/ML) SOLUTION INJECTION Rx AP 500MG/100ML (5MG/ML) SOLUTION INJECTION Rx AP 1GM/200ML (5MG/ML) SOLUTION INJECTION Rx AP 200MG/20ML (10MG/ML) SOLUTION INJECTION Rx AP 75MG/10ML (7.5MG/ML) SOLUTION INJECTION Discontinued — 50MG/10ML (5MG/ML) SOLUTION INJECTION Discontinued —
Generic (ANDA) products (16)
Abbreviated applications
- ROPIVACAINE HYDROCHLORIDEANTHEA PHARMAANDA 21988320255 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/20ML (2MG/ML) SOLUTION INJECTION Rx AP 150MG/30ML (5MG/ML) SOLUTION INJECTION Rx AP 200MG/20ML (10MG/ML) SOLUTION INJECTION Rx AP 20MG/10ML (2MG/ML) SOLUTION INJECTION Rx AP 100MG/20ML (5MG/ML) SOLUTION INJECTION Rx AP - ROPIVACAINE HYDROCHLORIDEHIKMAANDA 21190720243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) SOLUTION INJECTION Rx AP 400MG/200ML (2MG/ML) SOLUTION INJECTION Rx AP 500MG/100ML (5MG/ML) SOLUTION INJECTION Rx AP - ROPIVACAINE HYDROCHLORIDEKINDOSANDA 21871320247 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/10ML (2MG/ML) SOLUTION INJECTION Rx AP 40MG/20ML (2MG/ML) SOLUTION INJECTION Rx AP 100MG/20ML (5MG/ML) SOLUTION INJECTION Rx AP 100MG/10ML (10MG/ML) SOLUTION INJECTION Rx AP 150MG/30ML (5MG/ML) SOLUTION INJECTION Rx AP 150MG/20ML (7.5MG/ML) SOLUTION INJECTION Rx AP 200MG/20ML (10MG/ML) SOLUTION INJECTION Rx AP - ROPIVACAINE HYDROCHLORIDEMYLAN LABS LTDANDA 20609120232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) SOLUTION INJECTION Rx AP 400MG/200ML (2MG/ML) SOLUTION INJECTION Rx AP - ROPIVACAINE HYDROCHLORIDEAMNEALANDA 21660520234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) SOLUTION INJECTION Rx AP 400MG/200ML (2MG/ML) SOLUTION INJECTION Rx AP 500MG/100ML (5MG/ML) SOLUTION INJECTION Rx AP 1GM/200ML (5MG/ML) SOLUTION INJECTION Rx AP - ROPIVACAINE HYDROCHLORIDEGLANDANDA 21010220222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) SOLUTION INJECTION Rx AP 400MG/200ML (2MG/ML) SOLUTION INJECTION Rx AP - ROPIVACAINE HYDROCHLORIDEHIKMAANDA 21407420204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/20ML (2MG/ML) SOLUTION INJECTION Rx AP 150MG/30ML (5MG/ML) SOLUTION INJECTION Rx AP 150MG/20ML (7.5MG/ML) SOLUTION INJECTION Rx AP 200MG/20ML (10MG/ML) SOLUTION INJECTION Rx AP - ROPIVACAINE HYDROCHLORIDECAPLINANDA 21280820206 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/20ML (2MG/ML) SOLUTION INJECTION Rx AP 100MG/20ML (5MG/ML) SOLUTION INJECTION Rx AP 150MG/30ML (5MG/ML) SOLUTION INJECTION Rx AP 200MG/20ML (10MG/ML) SOLUTION INJECTION Rx AP 200MG/100ML (2MG/ML) SOLUTION INJECTION Rx AP 400MG/200ML (2MG/ML) SOLUTION INJECTION Rx AP - ROPIVACAINE HYDROCHLORIDESOMERSET THERAPS LLCANDA 20763620187 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/10ML (2MG/ML) SOLUTION INJECTION Rx AP 40MG/20ML (2MG/ML) SOLUTION INJECTION Rx AP 100MG/20ML (5MG/ML) SOLUTION INJECTION Rx AP 150MG/30ML (5MG/ML) SOLUTION INJECTION Rx AP 150MG/20ML (7.5MG/ML) SOLUTION INJECTION Rx AP 100MG/10ML (10MG/ML) SOLUTION INJECTION Rx AP 200MG/20ML (10MG/ML) SOLUTION INJECTION Rx AP - ROPIVACAINE HYDROCHLORIDEINFORLIFEANDA 20616620184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) SOLUTION INJECTION Rx AP 400MG/200ML (2MG/ML) SOLUTION INJECTION Rx AP 500MG/100ML (5MG/ML) SOLUTION INJECTION Rx AP 1GM/200ML (5MG/ML) SOLUTION INJECTION Rx AP - ROPIVACAINE HYDROCHLORIDERISINGANDA 20463620182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) SOLUTION INJECTION Rx AP 400MG/200ML (2MG/ML) SOLUTION INJECTION Rx AP - ROPIVACAINE HYDROCHLORIDEEUGIA PHARMAANDA 20561220167 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/20ML (2MG/ML) SOLUTION INJECTION Rx AP 200MG/100ML (2MG/ML) SOLUTION INJECTION Rx AP 100MG/20ML (5MG/ML) SOLUTION INJECTION Rx AP 150MG/30ML (5MG/ML) SOLUTION INJECTION Rx AP 150MG/20ML (7.5MG/ML) SOLUTION INJECTION Rx AP 100MG/10ML (10MG/ML) SOLUTION INJECTION Rx AP 200MG/20ML (10MG/ML) SOLUTION INJECTION Rx AP - ROPIVACAINE HYDROCHLORIDERISINGANDA 2039552016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG/30ML (5MG/ML) SOLUTION INJECTION Rx AP - ROPIVACAINE HYDROCHLORIDEHOSPIRAANDA 09019420146 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/10ML (2MG/ML) SOLUTION INJECTION Discontinued — 150MG/30ML (5MG/ML) SOLUTION INJECTION Discontinued — 150MG/20ML (7.5MG/ML) SOLUTION INJECTION Discontinued — 100MG/10ML (10MG/ML) SOLUTION INJECTION Discontinued — 40MG/20ML (2MG/ML) SOLUTION INJECTION Discontinued — 200MG/20ML (10MG/ML) SOLUTION INJECTION Discontinued — - ROPIVACAINE HYDROCHLORIDERISINGANDA 09031820144 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/20ML (2MG/ML) SOLUTION INJECTION Discontinued — 150MG/30ML (5MG/ML) SOLUTION INJECTION Discontinued — 150MG/20ML (7.5MG/ML) SOLUTION INJECTION Discontinued — 200MG/20ML (10MG/ML) SOLUTION INJECTION Discontinued — - ROPIVACAINE HYDROCHLORIDENAVINTA LLCANDA 07860120142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG/30ML (5MG/ML) SOLUTION INJECTION Rx AP 200MG/20ML (10MG/ML) SOLUTION INJECTION Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7857802 | in 3 mo | Product |
Approval history
FDA approval span
First approval
30 yr 4 mo ago
Most recent approval
11 mo ago
Approvals span 1996–2025 across 17 FDA applications.
Brand (NDA) 16%
Generic (ANDA) 1694%
Ropivacaine hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
