➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
AstraZeneca
Express Scripts
Medtronic
Moodys

Last Updated: July 6, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020356


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 020356 describes SULAR, which is a drug marketed by Covis Pharma Bv and is included in one NDA. It is available from two suppliers. Additional details are available on the SULAR profile page.

The generic ingredient in SULAR is nisoldipine. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.
Summary for 020356
Tradename:SULAR
Applicant:Covis Pharma Bv
Ingredient:nisoldipine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020356
Mechanism of ActionCalcium Channel Antagonists
Physiological EffectDecreased Blood Pressure
Medical Subject Heading (MeSH) Categories for 020356
Suppliers and Packaging for NDA: 020356
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-472 66993-472-02 1 BOTTLE in 1 CARTON (66993-472-02) > 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-473 66993-473-02 1 BOTTLE in 1 CARTON (66993-473-02) > 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Paragraph IV (Patent) Challenges for 020356
Tradename Dosage Ingredient NDA Submissiondate
SULAR TABLET, EXTENDED RELEASE;ORAL nisoldipine 020356 2009-03-02
SULAR TABLET, EXTENDED RELEASE;ORAL nisoldipine 020356 2008-11-28
SULAR TABLET, EXTENDED RELEASE;ORAL nisoldipine 020356 2007-11-07
SULAR TABLET, EXTENDED RELEASE;ORAL nisoldipine 020356 2007-06-11

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 2, 1995TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 2, 1995TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 2, 1995TE:RLD:Yes

Expired US Patents for NDA 020356

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-007 Jan 2, 2008   Start Trial   Start Trial
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-008 Jan 2, 2008   Start Trial   Start Trial
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-006 Jan 2, 2008   Start Trial   Start Trial
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-006 Jan 2, 2008   Start Trial   Start Trial
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-002 Feb 2, 1995   Start Trial   Start Trial
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-003 Feb 2, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
Baxter
Harvard Business School
Colorcon
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.