NICARDIPINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Nicardipine Hydrochloride, and when can generic versions of Nicardipine Hydrochloride launch?
Nicardipine Hydrochloride is a drug marketed by Amneal, Ani Pharms, Bionpharma, Chartwell Rx, Epic Pharma Llc, Glenmark Pharms Ltd, Pharmobedient, Senores Pharms, Am Regent, Chengdu Shuode, Eugia Pharma, Hikma, Hikma Intl Pharms, Mankind Pharma, Micro Labs, Nanjing King Friend, Navinta Llc, Qilu Pharm Hainan, Somerset Theraps Llc, Sun Pharm, Inforlife, Caplin, Cipla, and Fresenius Kabi Usa. and is included in twenty-seven NDAs.
The generic ingredient in NICARDIPINE HYDROCHLORIDE is nicardipine hydrochloride. Twenty-nine suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nicardipine Hydrochloride
A generic version of NICARDIPINE HYDROCHLORIDE was approved as nicardipine hydrochloride by ANI PHARMS on October 28th, 1996.
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Summary for NICARDIPINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 24 |
| NDAs: | 27 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NICARDIPINE HYDROCHLORIDE |
Paragraph IV (Patent) Challenges for NICARDIPINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER | Injection | nicardipine hydrochloride | 2.5 mg/mL, 10 mL Ampoules | 019734 | 1 | 2006-12-27 |
US Patents and Regulatory Information for NICARDIPINE HYDROCHLORIDE
| 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 | NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | nicardipine hydrochloride | INJECTABLE;INTRAVENOUS | 219334-002 | Aug 4, 2026 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Somerset Theraps Llc | NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 090664-001 | Nov 17, 2009 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Micro Labs | NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 216420-001 | Jul 7, 2023 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sun Pharm | NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 078405-001 | Nov 17, 2009 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
