SULAR Drug Patent Profile
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When do Sular patents expire, and what generic alternatives are available?
Sular is a drug marketed by Azurity and is included in one NDA.
The generic ingredient in SULAR is nisoldipine. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sular
A generic version of SULAR was approved as nisoldipine by AMTA on April 10th, 2023.
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Questions you can ask:
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Summary for SULAR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 93 |
| Patent Applications: | 4,946 |
| Drug Prices: | Drug price information for SULAR |
| What excipients (inactive ingredients) are in SULAR? | SULAR excipients list |
| DailyMed Link: | SULAR at DailyMed |
Pharmacology for SULAR
| Drug Class | Dihydropyridine Calcium Channel Blocker |
| Mechanism of Action | Calcium Channel Antagonists |
| Physiological Effect | Decreased Blood Pressure |
Paragraph IV (Patent) Challenges for SULAR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SULAR | Extended-release Tablets | nisoldipine | 8.5 mg and 17 mg | 020356 | 1 | 2009-03-02 |
| SULAR | Extended-release Tablets | nisoldipine | 25.5 mg and 34 mg | 020356 | 1 | 2008-11-28 |
| SULAR | Extended-release Tablets | nisoldipine | 20 mg and 30 mg | 020356 | 1 | 2007-11-07 |
| SULAR | Extended-release Tablets | nisoldipine | 40 mg | 020356 | 1 | 2007-06-11 |
US Patents and Regulatory Information for SULAR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Azurity | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-008 | Jan 2, 2008 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Azurity | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-005 | Jan 2, 2008 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Azurity | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-002 | Feb 2, 1995 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Azurity | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-004 | Feb 2, 1995 | 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 SULAR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Azurity | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-005 | Jan 2, 2008 | ⤷ Start Trial | ⤷ Start Trial |
| Azurity | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-008 | Jan 2, 2008 | ⤷ Start Trial | ⤷ Start Trial |
| Azurity | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-002 | Feb 2, 1995 | ⤷ Start Trial | ⤷ Start Trial |
| Azurity | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-006 | Jan 2, 2008 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SULAR
See the table below for patents covering SULAR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 44650 | ⤷ Start Trial | |
| Australia | 4840085 | ⤷ Start Trial | |
| Canada | 1251733 | COMBINAISON DE DIHYDROPYRIDINES AVEC DES INHIBITEURS DE L'ENZYME DE CONVERSION DE L'ANGIOTENSINE ET UTILISATION COMME MEDICAMENTS (COMBINATION OF DIHYDROPYRIDINES WITH ACE INHIBITORS AND THEIR USE IN MEDICAMENTS) | ⤷ Start Trial |
| German Democratic Republic | 239525 | VERFAHREN ZUR HERSTELLUNG EINER KOMBINATION VON DIHYDROPYRIDENEN MIT ACE-HEMMERN | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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