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 Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Norvium Bioscience, Senores Pharms, Skg Pharma, Am Regent, Chengdu Shuode, Eugia Pharma, Hikma Intl Pharms, Micro Labs, Navinta Llc, Rk Pharma, Sun Pharm, West-ward Pharms Int, Wockhardt, Inforlife, and Cipla. and is included in twenty-one NDAs.
The generic ingredient in NICARDIPINE HYDROCHLORIDE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Twenty-four 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: | 19 |
| NDAs: | 21 |
| Finished Product Suppliers / Packagers: | 22 |
| Raw Ingredient (Bulk) Api Vendors: | 107 |
| Clinical Trials: | 53 |
| Patent Applications: | 1,573 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NICARDIPINE HYDROCHLORIDE |
| What excipients (inactive ingredients) are in NICARDIPINE HYDROCHLORIDE? | NICARDIPINE HYDROCHLORIDE excipients list |
| DailyMed Link: | NICARDIPINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for NICARDIPINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Boston Medical Center | Phase 4 |
| University of Illinois at Chicago | Early Phase 1 |
| Nanjing First Hospital, Nanjing Medical University | N/A |
Pharmacology for NICARDIPINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for NICARDIPINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes 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
NICARDIPINE HYDROCHLORIDE is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting NICARDIPINE HYDROCHLORIDE
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cipla | NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | nicardipine hydrochloride | INJECTABLE;INTRAVENOUS | 215592-002 | Sep 24, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Wockhardt | NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 090671-001 | Nov 17, 2009 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma Intl Pharms | NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | nicardipine hydrochloride | INJECTABLE;INTRAVENOUS | 022276-002 | Apr 7, 2016 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Inforlife | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | nicardipine hydrochloride | INJECTABLE;INTRAVENOUS | 203978-002 | Apr 17, 2024 | 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 |
