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Ropivacaine hydrochloride - Generic Drug Details
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What are the generic drug sources for ropivacaine hydrochloride and what is the scope of patent protection?
Ropivacaine hydrochloride
is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Akorn, Akorn Inc, Aurobindo Pharma Ltd, Caplin, Hikma, Hospira, Inforlife, Mylan Asi, Navinta Llc, and Somerset Theraps Llc, and is included in eleven 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-five patent family members in twenty countries.
There are thirteen drug master file entries for ropivacaine hydrochloride. Eleven suppliers are listed for this compound.
Summary for ropivacaine hydrochloride
| International Patents: | 75 |
| US Patents: | 4 |
| Tradenames: | 2 |
| Applicants: | 11 |
| NDAs: | 11 |
| Drug Master File Entries: | 13 |
| Suppliers / Packagers: | 11 |
| Bulk Api Vendors: | 149 |
| Clinical Trials: | 669 |
| Patent Applications: | 4,701 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ropivacaine hydrochloride |
| DailyMed Link: | ropivacaine hydrochloride at DailyMed |
Recent Clinical Trials for ropivacaine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Beijing Sanbo Brain Hospital | Phase 4 |
| Xuanwu Hospital, Beijing | Phase 4 |
| University of Minnesota | Phase 4 |
Pharmacology for ropivacaine hydrochloride
| Drug Class | Amide Local Anesthetic |
| Physiological Effect | Local Anesthesia |
Paragraph IV (Patent) Challenges for ROPIVACAINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NAROPIN | SOLUTION;INJECTION | ropivacaine hydrochloride | 020533 | 2015-09-03 |
| NAROPIN | SOLUTION;INJECTION | ropivacaine hydrochloride | 020533 | 2015-01-30 |
| NAROPIN | SOLUTION;INJECTION | ropivacaine hydrochloride | 020533 | 2006-11-13 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 214074-003 | Jul 20, 2020 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-006 | Sep 24, 1996 | AP | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Hospira | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 090194-001 | Sep 23, 2014 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-007 | Sep 24, 1996 | AP | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-013 | May 1, 1998 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Akorn | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 204636-002 | Mar 16, 2018 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >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 | 020533-005 | Sep 24, 1996 | Start Trial | Start Trial |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-005 | Sep 24, 1996 | Start Trial | Start Trial |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-004 | Sep 24, 1996 | Start Trial | Start Trial |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-001 | May 1, 1998 | Start Trial | Start Trial |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-003 | May 1, 1998 | Start Trial | Start Trial |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-001 | May 1, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ropivacaine hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2004281535 | Start Trial |
| Denmark | 1605891 | Start Trial |
| Germany | 10223560 | Start Trial |
| Brazil | PI0408780 | Start Trial |
| Australia | 2003208752 | Start Trial |
| Hong Kong | 1081430 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ropivacaine hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0239710 | SPC/GB96/051 | United Kingdom | Start Trial | 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 |
| 0239710 | 96C0042 | Belgium | Start Trial | PRODUCT NAME: CHLORHYDRATE DE ROPIVACAINE MONOHYDRATE; NAT. REGISTRATION NO/DATE: 212 IS 216 F 12 19960806; FIRST REGISTRATION: SE 12319 19950915 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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ISSN: 2162-2639
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LOE / Major Patent Expirations 2020 - 2021
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
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