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Ropivacaine hydrochloride - Generic Drug Details
What are the generic drug sources for ropivacaine hydrochloride and what is the scope of ropivacaine hydrochloride patent protection?
Ropivacaine hydrochloride
is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Akorn, Akorn Inc, Aurobindo Pharma Ltd, Hospira, Inforlife, Mylan Asi, Navinta Llc, and Somerset Theraps Llc, and is included in nine NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Ropivacaine hydrochloride has seventy-four patent family members in twenty countries.
There are thirteen drug master file entries for ropivacaine hydrochloride. Nine suppliers are listed for this compound.
Summary for ropivacaine hydrochloride
| International Patents: | 74 |
| US Patents: | 4 |
| Tradenames: | 2 |
| Applicants: | 9 |
| NDAs: | 9 |
| Drug Master File Entries: | 13 |
| Suppliers / Packagers: | 9 |
| Bulk Api Vendors: | 45 |
| Clinical Trials: | 561 |
| Patent Applications: | 253 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ropivacaine hydrochloride |
| DailyMed Link: | ropivacaine hydrochloride at DailyMed |
Pharmacology for ropivacaine hydrochloride
| Drug Class | Amide Local Anesthetic |
| Physiological Effect | Local Anesthesia |
Synonyms for ropivacaine hydrochloride
| (-)-1-Propyl-2',6'-dimethyl-2-piperidylcarboxyanilid |
| (-)-1-propyl-2',6'-dimethyl-2-piperidylcarboxyanilide |
| (-)-1-Propyl-2',6'-pipecoloxylidide |
| (-)-Ropivacaine |
| (2S)-2-[(2,6-dimethylphenyl)carbamoyl]-1-propylpiperidinium chloride |
| (2S)-2-[(2,6-dimethylphenyl)carbamoyl]-1-propylpiperidinium chloride--water(1/1) |
| (2S)-N-(2,6-dimethylphenyl)-1-propyl-2-piperidinecarboxamide |
| (2S)-N-(2,6-dimethylphenyl)-1-propyl-2-piperidinecarboxamide hydrochloride monohydrate |
| (2S)-N-(2,6-dimethylphenyl)-1-propyl-piperidine-2-carboxamide |
| (2S)-N-(2,6-dimethylphenyl)-1-propyl-piperidine-2-carboxamide hydrate hydrochloride |
| (2S)-N-(2,6-dimethylphenyl)-1-propyl-piperidine-2-carboxamide hydrochloride |
| (2S)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide |
| (2S)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrate hydrochloride |
| (2S)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrochloride |
| (2S)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrochloride--water (1/1) |
| (S)-(--)-1-propyl-2',6'-pipecoloxylidide hydrochloride |
| (S)-(-)-1-propyl-2',6'-pipecoloxylidide |
| (S)-(-)-1-propyl-2',6'-pipecoloxylidine hydrochloride monohydrate |
| (S)-(-)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)amide hydrochloride monohydrate |
| (S)-1-propyl-2-piperidylformo-2',6'-xylidide hydrochloride |
| (S)-N-(2,6-Dimethylphenyl)-1-propylpiperidine-2-carboxamide |
| (S)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrochloride monohydrate |
| (S)-Ropivacaine |
| (S)-ropivacaine HCl |
| (S)-Ropivacaine hydrochloride |
| (S)-ropivacaine hydrochloride (anhydrous) |
| (S)-ropivacaine hydrochloride hydrate |
| (S)-ropivacaine hydrochloride monohydrate |
| (S)-ropivacaine monohydrochloride (anhydrous) |
| 057R954 |
| 112R357 |
| 132112-35-7 |
| 2-Piperidinecarboxamide, N-(2,6-dimethylphenyl)-1-propyl-, (2S)- |
| 2-Piperidinecarboxamide, N-(2,6-dimethylphenyl)-1-propyl-, (S)-(-)- |
| 2-Piperidinecarboxamide, N-(2,6-dimethylphenyl)-1-propyl-, monohydrochloride, (S)- |
| 2-Piperidinecarboxamide,N-(2,6-dimethylphenyl)-1-propyl-, (2S)- |
| 2694AH |
| 35504LBE2T |
| 717R158 |
| 7IO5LYA57N |
| 84057-95-4 |
| 98717-15-8 |
| A840710 |
| AB0004985 |
| AB00698466_10 |
| AB00698466-07 |
| AB1007072 |
| AC-2101 |
| AC1L41QM |
| AC1L41QN |
| AC1OCF17 |
| ACT04747 |
| AJ-24263 |
| AK117722 |
| AK161933 |
| AK326168 |
| AKOS015900322 |
| AKOS015918210 |
| AKOS015950974 |
| AKOS015994752 |
| AKOS017343283 |
| AL-281 |
| AL-381 |
| AN-14289 |
| AN-9624 |
| Anapaine |
| Anapeine |
| Anapeine (TN) |
| API0007295 |
| B3377 |
| BC209065 |
| BIDD:GT0203 |
| C07532 |
| C17H26N2O.ClH |
| C17H26N2O.HCl |
| C17H26N2O.HCl.H2O |
| CAS-98717-15-8 |
| CCG-101108 |
| CHEBI:34954 |
| CHEBI:60803 |
| CHEBI:8890 |
| CHEMBL1077896 |
| CHEMBL1889140 |
| CPD000469137 |
| CS-0013146 |
| CS-2672 |
| D04048 |
| D08490 |
| D09RHQ |
| DB00296 |
| DR000904 |
| DSSTox_CID_28353 |
| DSSTox_GSID_48379 |
| DSSTox_RID_82753 |
| DTXSID2048379 |
| DTXSID4040187 |
| ETI-211 |
| F-93 |
| FC1264 |
| FT-0631143 |
| FT-0674459 |
| GTPL7602 |
| H838 |
| HE306542 |
| HE395698 |
| HY-B0563A |
| HY-B0563B |
| I14-176 |
| I14-8019 |
| K500 |
| KB-60355 |
| KB-60356 |
| KS-5134 |
| L-N-(2,6-dimethylphenyl)-1-propyl-2-piperidinocarboxamide hydrochloride monohydrate |
| L-N-n-propylpipecolic acid-2,6-xylidide |
| L-N-n-propylpipecolic acid-2,6-xylidide hydrochloride |
| L-ropivacaine HCl |
| L-ropivacaine hydrochloride |
| L-ropivacaine hydrochloride monohydrate |
| LEA 103 |
| LS-113954 |
| MFCD00864425 |
| MFCD00946578 |
| MFCD02102164 |
| MLS001401363 |
| MolPort-003-983-292 |
| MolPort-005-935-350 |
| MolPort-006-069-213 |
| N-(2,6-dimethylphenyl)-1-propyl-piperidine-2-carboxamide; hydron; chloride |
| Narapin |
| Narop |
| Naropeine |
| Naropin |
| Naropin (TN) |
| Naropin hydrochloride monohydrate |
| Naropina |
| naropine |
| NC00358 |
| NCGC00164597-01 |
| NCGC00164597-02 |
| NDNSIBYYUOEUSV-RSAXXLAASA-N |
| Noropine |
| PRF-108 |
| Q-100126 |
| Q-201677 |
| Q-201678 |
| Ropivacaina |
| Ropivacaina [INN-Spanish] |
| Ropivacaina [Spanish] |
| Ropivacaine |
| Ropivacaine (hydrochloride monohydrate) |
| Ropivacaine (INN) |
| Ropivacaine [INN:BAN] |
| Ropivacaine [INN] |
| Ropivacaine base |
| ROPIVACAINE HCl |
| Ropivacaine hydrochloride (USP) |
| Ropivacaine hydrochloride [USP] |
| Ropivacaine hydrochloride hydrate |
| Ropivacaine hydrochloride hydrate (JAN) |
| ROPIVACAINE HYDROCHLORIDE MONOHYDRATE |
| Ropivacaine hydrochloride monohydrate, >=98% (HPLC) |
| Ropivacaine hydrochloride monohydrate, European Pharmacopoeia (EP) Reference Standard |
| Ropivacaine hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| Ropivacaine monohydrochloride |
| ropivacaine monohydrochloride, |
| ropivacaine monohydrochloride, (S)-isomer |
| ropivacaine monohydrochloride, (S)-isomer |
| Ropivacainehydrochloridehydrate |
| Ropivacainum |
| Ropivacainum [INN-Latin] |
| S-Ropivacaine |
| S-Ropivacaine hydrochloride |
| s4058 |
| SAM001246524 |
| SC-23114 |
| SC-26798 |
| SCHEMBL236432 |
| SCHEMBL33292 |
| SCHEMBL510838 |
| SMR000469137 |
| ST24049128 |
| ST51051452 |
| ST51054447 |
| Tox21_112221 |
| Tox21_112221_1 |
| UNII-35504LBE2T |
| UNII-7IO5LYA57N |
| UNII-V910P86109 |
| V910P86109 |
| VSHFRHVKMYGBJL-CKUXDGONSA-N |
| ZINC897002 |
| ZKMNUMMKYBVTFN-HNNXBMFYSA-N |
US Patents and Regulatory Information for ropivacaine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Somerset Theraps Llc | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 207636-005 | Jun 15, 2018 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-003 | May 1, 1998 | AP | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Aurobindo Pharma Ltd | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 205612-001 | Jul 13, 2016 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Somerset Theraps Llc | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 207636-001 | Jun 15, 2018 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Hospira | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 090194-003 | Sep 23, 2014 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-013 | May 1, 1998 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Expired US Patents for ropivacaine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-003 | May 1, 1998 | ➤ Sign Up | ➤ Sign Up |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-004 | Sep 24, 1996 | ➤ Sign Up | ➤ Sign Up |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-005 | Sep 24, 1996 | ➤ Sign Up | ➤ Sign Up |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-001 | May 1, 1998 | ➤ Sign Up | ➤ Sign Up |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-003 | May 1, 1998 | ➤ Sign Up | ➤ Sign Up |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-004 | Sep 24, 1996 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for ropivacaine hydrochloride
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1089080 | ➤ Sign Up |
| Germany | 10313760 | ➤ Sign Up |
| Poland | 209530 | ➤ Sign Up |
| Japan | 2005527301 | ➤ Sign Up |
| European Patent Office | 1673135 | ➤ Sign Up |
| South Korea | 20070007248 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ropivacaine hydrochloride
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C/GB96/051 | United Kingdom | ➤ Sign Up | PRODUCT NAME: (S)-(-)-1-PROPYL-2',6'-PIPECOLOXYLIDIDE HYDROCHLORIDE MONOHYDRATE (GENERIC NAME: ROPIVACAINE MONOHYDROCHLORIDE MONOHYDRATE); REGISTERED: SE 12319 19950915; SE 12322 19950915; SE 12323 19950915; UK 0017/0375 19960517; UK 0017/0376 19960517; UK 0017/0377 19960517; UK 0017/0378 19960517 |
| C0042 | Belgium | ➤ Sign Up | PRODUCT NAME: CHLORHYDRATE DE ROPIVACAINE MONOHYDRATE; NAT. REGISTRATION NO/DATE: 212 IS 216 F 12 19960806; FIRST REGISTRATION: SE 12319 19950915 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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