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NAROPIN Drug Profile
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This drug has sixty-four patent family members in twenty countries.
The generic ingredient in NAROPIN is ropivacaine hydrochloride. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.
Summary for Tradename: NAROPIN
| Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 3 |
| Drug Prices: : | see details |
Pharmacology for Tradename: NAROPIN
| Ingredient-type | Amides |
| Drug Class | Amide Local Anesthetic |
| Physiological Effect | Local Anesthesia |
Clinical Trials for: NAROPIN
| 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 | 020533-010 | Jan 4, 2011 | RX | No | ||||||||||||||||||||||
Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-007 | Sep 24, 1996 | RX | No | 7,857,802 | Nov 28, 2026 | Y | |||||||||||||||||||
Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-005 | Sep 24, 1996 | RX | No | ||||||||||||||||||||||
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Expired Patents for Tradename: NAROPIN
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-004 | Sep 24, 1996 | 5,670,524 | <disabled> | ||||||||||||||||||||||
Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-004 | Sep 24, 1996 | 5,834,489 | <disabled> | ||||||||||||||||||||||
Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-005 | Sep 24, 1996 | 5,834,489 | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: NAROPIN
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ropivacaine hydrochloride | Injection | 2 mg/mL, 200 mL | Naropin | 9/3/2015 |
| ropivacaine hydrochloride | Injection | 2 mg/mL, 100 mL | Naropin | 1/30/2015 |
| ropivacaine hydrochloride | Injection | 2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials | Naropin | 11/13/2006 |
International Patent Family for Tradename: NAROPIN
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Portugal | 1605891 | <disabled in preview> | |||||||||||||||||||||||||||
| Brazil | 0311342 | <disabled in preview> | |||||||||||||||||||||||||||
| Portugal | 1673135 | <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: NAROPIN
| 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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