ROPIVACAINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Ropivacaine Hydrochloride, and when can generic versions of Ropivacaine Hydrochloride launch?
Ropivacaine Hydrochloride is a drug marketed by Amneal, Caplin, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Inforlife, Kindos, Mylan Labs Ltd, Navinta Llc, Rising, and Somerset Theraps Llc. and is included in fifteen NDAs.
The generic ingredient in ROPIVACAINE HYDROCHLORIDE 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 Ropivacaine Hydrochloride
A generic version of ROPIVACAINE HYDROCHLORIDE was approved as ropivacaine hydrochloride by NAVINTA LLC on July 17th, 2014.
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Summary for ROPIVACAINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 12 |
| NDAs: | 15 |
| Finished Product Suppliers / Packagers: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 189 |
| Clinical Trials: | 865 |
| Patent Applications: | 272 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ROPIVACAINE HYDROCHLORIDE |
| DailyMed Link: | ROPIVACAINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for ROPIVACAINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| McMaster University | Phase 4 |
| Ziekenhuis Oost-Limburg | N/A |
| Massachusetts General Hospital | Phase 2 |
Pharmacology for ROPIVACAINE HYDROCHLORIDE
| Drug Class | Amide Local Anesthetic |
| Physiological Effect | Local Anesthesia |
Anatomical Therapeutic Chemical (ATC) Classes for ROPIVACAINE HYDROCHLORIDE
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Kindos | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 218713-005 | Jul 30, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hospira | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 090194-006 | Sep 23, 2014 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 204636-002 | Mar 16, 2018 | AP | RX | No | 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 |
