nicardipine hydrochloride - Profile
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What are the generic 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, Amneal, Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Navinta Llc, Pharmobedient, Senores Pharms, Am Regent, Chengdu Shuode, Eugia Pharma, Hikma, Hikma Intl Pharms, Mankind Pharma, Micro Labs, Nanjing King Friend, Qilu Pharm Hainan, Somerset Theraps Llc, Sun Pharm, Inforlife, Caplin, and Cipla, and is included in twenty-nine 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.
Summary for nicardipine hydrochloride
| International Patents: | 21 |
| US Patents: | 6 |
| Tradenames: | 10 |
| Applicants: | 23 |
| NDAs: | 29 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chiesi | CARDENE SR | nicardipine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020005-001 | Feb 21, 1992 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Chiesi | CARDENE SR | nicardipine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020005-002 | Feb 21, 1992 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Chiesi | CARDENE SR | nicardipine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020005-003 | Feb 21, 1992 | DISCN | Yes | 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 |
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 | 020005-003 | Feb 21, 1992 | 5,198,226 | ⤷ Start Trial |
| Chiesi | CARDENE SR | nicardipine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020005-001 | Feb 21, 1992 | 3,985,758 | ⤷ Start Trial |
| Chiesi | CARDENE SR | nicardipine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020005-002 | Feb 21, 1992 | 3,985,758 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for nicardipine hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2007237903 | ⤷ Start Trial | |
| Australia | 2007240820 | Pre-mixed, ready-to-use pharmaceutical compositions | ⤷ Start Trial |
| Brazil | PI0709617 | composição farmacêutica, e, métodos para tratar elevações agudas de pressão sangüìnea em um indivìduo humano, para induzir a hipotensão em um indivìduo humano, e para produzir uma composição farmacêutica para administração intravenosa | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
