Nicardipine hydrochloride - Generic Drug Details
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What are the generic drug sources for nicardipine hydrochloride and what is the scope of patent protection?
Nicardipine hydrochloride
is the generic ingredient in ten branded drugs marketed by Chiesi, 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, and Inforlife, and is included in twenty-three NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Nicardipine hydrochloride has twenty-one patent family members in ten countries.
There are eleven drug master file entries for nicardipine hydrochloride. Twenty-two suppliers are listed for this compound.
Summary for nicardipine hydrochloride
International Patents: | 21 |
US Patents: | 6 |
Tradenames: | 10 |
Applicants: | 19 |
NDAs: | 23 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 22 |
Raw Ingredient (Bulk) Api Vendors: | 107 |
Clinical Trials: | 53 |
Patent Applications: | 2,590 |
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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Epic Pharma Llc | NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | CAPSULE;ORAL | 074928-001 | Mar 19, 1998 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Glenmark Pharms Ltd | NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | CAPSULE;ORAL | 216357-001 | Dec 16, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
West-ward Pharms Int | NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 078714-001 | Dec 28, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Chiesi | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | nicardipine hydrochloride | INJECTABLE;INTRAVENOUS | 019734-004 | Nov 7, 2008 | AP | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for nicardipine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Chiesi | CARDENE SR | nicardipine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020005-002 | Feb 21, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Chiesi | CARDENE SR | nicardipine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020005-001 | Feb 21, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Chiesi | CARDENE | nicardipine hydrochloride | INJECTABLE;INJECTION | 019734-001 | Jan 30, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Chiesi | CARDENE | nicardipine hydrochloride | INJECTABLE;INJECTION | 019734-001 | Jan 30, 1992 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for nicardipine hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2009534388 | ⤷ Sign Up | |
South Korea | 20090037388 | PRE-MIXED, READY-TO-USE IV BOLUS COMPOSITIONS AND METHODS OF USE | ⤷ Sign Up |
China | 101484006 | Pre-mixed, ready-to-use iv bolus compositions and methods of use | ⤷ Sign Up |
European Patent Office | 2012788 | COMPOSITIONS EN BOLUS IV PRE-MELANGEES PRETES A L'EMPLOI ET PROCEDES D'UTILISATION (PRE-MIXED, READY-TO-USE IV BOLUS COMPOSITIONS AND METHODS OF USE) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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