NAROPIN Drug Patent Profile
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Which patents cover Naropin, and when can generic versions of Naropin launch?
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.
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: | 158 |
Patent Applications: | 5,690 |
Formulation / Manufacturing: | see details |
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 |
---|---|
United States Department of Defense | Phase 2 |
The University of Texas Health Science Center at San Antonio | Phase 2 |
Weill Medical College of Cornell University | Phase 4 |
Pharmacology for NAROPIN
Drug Class | Amide Local Anesthetic |
Physiological Effect | Local Anesthesia |
Anatomical Therapeutic Chemical (ATC) Classes for NAROPIN
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Connector for medical liquid-containing packages and medical liquid-containing packages
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Connector for packings containing medical liquids, and corresponding packing for medical liquids
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Expired US Patents for NAROPIN
International Patents for NAROPIN
See the table below for patents covering NAROPIN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Slovenia | 1507502 | ⤷ Try a Trial | |
Japan | 2007508081 | ⤷ Try a Trial | |
Germany | 10313760 | Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen und Verpackung für medizinische Flüssigkeiten (Connector for a bag containing medical fluids, for e.g. transfusion/infusion, has a connector with a clamp section integrated into the package by an expanded base and without a connection tube) | ⤷ Try a Trial |
Denmark | 1605891 | ⤷ Try a Trial | |
Denmark | 1507502 | ⤷ Try a Trial | |
Norway | 331003 | ⤷ Try a Trial | |
Canada | 2518617 | CONNECTEUR POUR EMBALLAGES CONTENANT DES LIQUIDES MEDICAUX ET EMBALLAGE POUR LIQUIDES MEDICAUX (CONNECTOR FOR PACKINGS CONTAINING MEDICAL LIQUIDS, AND CORRESPONDING PACKING FOR MEDICAL LIQUIDS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NAROPIN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0239710 | 96C0042 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CHLORHYDRATE DE ROPIVACAINE MONOHYDRATE; NAT. REGISTRATION NO/DATE: 212 IS 216 F 12 19960806; FIRST REGISTRATION: SE 12319 19950915 |
0239710 | C960005 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ROPIVACAINI HYDROCHLORIDUM MONOHYDRICUM; NAT. REGISTRATION NO/DATE: RVG 18437, RVG 18440, RVG 18441 19951003; FIRST REGISTRATION: SE 12319, 12322, 12323 19950915 |
0239710 | SPC/GB96/051 | United Kingdom | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |