Ropivacaine hydrochloride - Generic Drug Details
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What are the generic drug sources for ropivacaine hydrochloride and what is the scope of patent protection?
Ropivacaine hydrochloride
is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Akorn, Caplin, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Inforlife, Navinta Llc, Rising, and Somerset Theraps Llc, and is included in twelve NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Ropivacaine hydrochloride has seventy-six patent family members in twenty countries.
There are ten drug master file entries for ropivacaine hydrochloride. Thirteen suppliers are listed for this compound.
Summary for ropivacaine hydrochloride
International Patents: | 76 |
US Patents: | 4 |
Tradenames: | 2 |
Applicants: | 11 |
NDAs: | 12 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 13 |
Raw Ingredient (Bulk) Api Vendors: | 178 |
Clinical Trials: | 810 |
Patent Applications: | 6,678 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ropivacaine hydrochloride |
What excipients (inactive ingredients) are in ropivacaine hydrochloride? | ropivacaine hydrochloride excipients list |
DailyMed Link: | ropivacaine hydrochloride at DailyMed |
Recent Clinical Trials for ropivacaine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Beijing Friendship Hospital | N/A |
Aga Khan University Hospital, Pakistan | Phase 4 |
Security Forces Hospital | Phase 4 |
Pharmacology for ropivacaine hydrochloride
Drug Class | Amide Local Anesthetic |
Physiological Effect | Local Anesthesia |
Paragraph IV (Patent) Challenges for ROPIVACAINE HYDROCHLORIDE
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 ropivacaine hydrochloride
Expired US Patents for ropivacaine hydrochloride
International Patents for ropivacaine hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 502004008025 | See Plans and Pricing | |
European Patent Office | 2191807 | Raccord pour emballages contenant des liquides médicinaux et emballage pour liquides médicinaux (Connector for packaging containing medical fluids and packaging for medical fluids) | See Plans and Pricing |
South Korea | 100944420 | See Plans and Pricing | |
Poland | 373496 | Łącznik do opakowań zawierających płyny stosowanew medycynie i opakowanie płynów stosowanych w medycynie (CONNECTOR FOR PACKAGING CONTAINING MEDICAL FLUIDS AND PACKAGING FOR MEDICAL FLUIDS) | See Plans and Pricing |
Poland | 209530 | See Plans and Pricing | |
Austria | 407653 | See Plans and Pricing | |
Slovenia | 1507502 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ropivacaine hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0239710 | 96C0042 | Belgium | See Plans and Pricing | PRODUCT NAME: CHLORHYDRATE DE ROPIVACAINE MONOHYDRATE; NAT. REGISTRATION NO/DATE: 212 IS 216 F 12 19960806; FIRST REGISTRATION: SE 12319 19950915 |
0239710 | SPC/GB96/051 | United Kingdom | See Plans and Pricing | 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 |
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