NAROPIN Drug Patent Profile
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When do Naropin patents expire, and what generic alternatives are available?
Naropin is a drug marketed by Fresenius Kabi Usa and is included in one NDA. There are three patents protecting this drug and three Paragraph IV challenges.
This drug has seventy-six patent family members in twenty countries.
The generic ingredient in NAROPIN is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Naropin
A generic version of NAROPIN was approved as ropivacaine hydrochloride by NAVINTA LLC on July 17th, 2014.
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Summary for NAROPIN
| International Patents: | 76 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 159 |
| Patent Applications: | 4,674 |
| Drug Prices: | Drug price information for NAROPIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NAROPIN |
| What excipients (inactive ingredients) are in NAROPIN? | NAROPIN excipients list |
| DailyMed Link: | NAROPIN at DailyMed |
Recent Clinical Trials for NAROPIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hartford Hospital | Phase 4 |
| The University of Texas Health Science Center at San Antonio | Phase 2 |
| United States Department of Defense | Phase 2 |
Pharmacology for NAROPIN
| Drug Class | Amide Local Anesthetic |
| Physiological Effect | Local Anesthesia |
Paragraph IV (Patent) Challenges for NAROPIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NAROPIN | Injection | ropivacaine hydrochloride | 2 mg/mL, 200 mL | 020533 | 1 | 2015-09-03 |
| NAROPIN | Injection | ropivacaine hydrochloride | 2 mg/mL, 100 mL | 020533 | 1 | 2015-01-30 |
| NAROPIN | Injection | ropivacaine hydrochloride | 2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials | 020533 | 1 | 2006-11-13 |
US Patents and Regulatory Information for NAROPIN
NAROPIN is protected by three US patents.
Patents protecting NAROPIN
Connector for packaging containing medical fluids and packaging for medical fluids
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Connector for medical liquid-containing packages and medical liquid-containing packages
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Connector for packings containing medical liquids, and corresponding packing for medical liquids
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-010 | Jan 4, 2011 | AP | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-005 | Sep 24, 1996 | AP | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-002 | Sep 24, 1996 | AP | RX | Yes | 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 NAROPIN
| 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 | 020533-007 | Sep 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-006 | Sep 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NAROPIN
See the table below for patents covering NAROPIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 100918859 | ⤷ Sign Up | |
| Finland | 870003 | ⤷ Sign Up | |
| Iceland | 4174 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NAROPIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0239710 | SPC/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 |
| 0239710 | C960005 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ROPIVACAINI HYDROCHLORIDUM MONOHYDRICUM; NAT. REGISTRATION NO/DATE: RVG 18437, RVG 18440, RVG 18441 19951003; FIRST REGISTRATION: SE 12319, 12322, 12323 19950915 |
| 0239710 | 96C0042 | Belgium | ⤷ Sign Up | 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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