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Generated: July 23, 2017
What are the generic 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 Navinta Llc, Aurobindo Pharma Ltd, Sagent Strides, Fresenius Kabi Usa, Akorn Inc, and Hospira, and is included in six NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 5 |
| Applicants: | 6 |
| NDAs: | 6 |
| Drug Master File Entries: see list | 13 |
| Suppliers / Packagers: see list | 8 |
| Bulk Api Vendors: see list | 93 |
| Clinical Trials: see list | 2,610 |
| Patent Applications: see list | 4,691 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | ropivacaine hydrochloride at DailyMed |
| Ingredient-type | Amides |
| Drug Class | Amide Local Anesthetic |
| Physiological Effect | Local Anesthesia |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hospira | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 090194-001 | Sep 23, 2014 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sagent Strides | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 090318-004 | Sep 23, 2014 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-007 | Sep 24, 1996 | RX | Yes | No | 7,828,787 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Hospira | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 090194-004 | Sep 23, 2014 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Hospira | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 090194-003 | Sep 23, 2014 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| 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 | 5,834,489 | ► Subscribe | ||||||||||||||||||||||
Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-003 | May 1, 1998 | 4,695,576 | ► Subscribe | ||||||||||||||||||||||
Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-003 | May 1, 1998 | 4,870,086 | ► Subscribe | ||||||||||||||||||||||
Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-001 | May 1, 1998 | 4,695,576 | ► Subscribe | ||||||||||||||||||||||
Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-003 | May 1, 1998 | 5,670,524 | ► Subscribe | ||||||||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 03099191 | ► Subscribe | |||||||||||||||||||||||||||
| South Africa | 200506747 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2191807 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2405262 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1767799 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB96/051 | United Kingdom | ► Subscribe | 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 | ► Subscribe | PRODUCT NAME: CHLORHYDRATE DE ROPIVACAINE MONOHYDRATE; NAT. REGISTRATION NO/DATE: 212 IS 216 F 12 19960806; FIRST REGISTRATION: SE 12319 19950915 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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