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Ropivacaine hydrochloride - Generic Drug Details
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This ingredient has sixty-four patent family members in twenty countries.
There are twelve drug master file entries for ropivacaine hydrochloride. Eight suppliers are listed for this compound.
Summary for Generic Name: ropivacaine hydrochloride
| Tradenames: | 2 |
| Patents: | 4 |
| Applicants: | 6 |
| NDAs: | 6 |
| Drug Master File Entries: see list | 12 |
| Suppliers / Packaging: see list | 8 |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: ropivacaine hydrochloride
| Ingredient-type | Amides |
| Drug Class | Amide Local Anesthetic |
| Physiological Effect | Local Anesthesia |
Clinical Trials for: ropivacaine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-007 | Sep 24, 1996 | RX | No | 8,162,915 | May 23, 2024 | Y | |||||||||||||||||||
Akorn Inc | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | INJECTABLE;INJECTION | 203955-001 | Apr 11, 2016 | RX | No | ||||||||||||||||||||||
Sagent Strides | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 090318-004 | Sep 23, 2014 | RX | No | ||||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: ropivacaine hydrochloride
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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 | 4,870,086 | <disabled> | ||||||||||||||||||||||
Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-001 | May 1, 1998 | 4,695,576 | <disabled> | ||||||||||||||||||||||
Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-003 | May 1, 1998 | 5,834,489 | <disabled> | ||||||||||||||||||||||
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International Patent Family for Ingredient: ropivacaine hydrochloride
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Poland | 209530 | <disabled in preview> | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 03099191 | <disabled in preview> | |||||||||||||||||||||||||||
| Norway | 20053981 | <disabled in preview> | |||||||||||||||||||||||||||
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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 Certificates for Tradename: ROPIVACAINE HYDROCHLORIDE
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB96/051 | United Kingdom | <disabled> | 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 | <disabled> | 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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