NISOLDIPINE - Generic Drug Details
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What are the generic drug sources for nisoldipine and what is the scope of patent protection?
Nisoldipine
is the generic ingredient in two branded drugs marketed by Amta, Mylan, and Covis, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.There are eight drug master file entries for nisoldipine. Four suppliers are listed for this compound.
Summary for NISOLDIPINE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 4 |
| Drug Master File Entries: | 8 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 117 |
| Clinical Trials: | 6 |
| Patent Applications: | 7,004 |
| Drug Prices: | Drug price trends for NISOLDIPINE |
| What excipients (inactive ingredients) are in NISOLDIPINE? | NISOLDIPINE excipients list |
| DailyMed Link: | NISOLDIPINE at DailyMed |
Recent Clinical Trials for NISOLDIPINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Menarini International Operations Luxembourg SA | Phase 4 |
| Mylan Pharmaceuticals | Phase 1 |
| Bayer | Phase 4 |
Pharmacology for NISOLDIPINE
| Drug Class | Dihydropyridine Calcium Channel Blocker |
| Mechanism of Action | Calcium Channel Antagonists |
| Physiological Effect | Decreased Blood Pressure |
Medical Subject Heading (MeSH) Categories for NISOLDIPINE
Anatomical Therapeutic Chemical (ATC) Classes for NISOLDIPINE
Paragraph IV (Patent) Challenges for NISOLDIPINE
| 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 NISOLDIPINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | NISOLDIPINE | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 091001-004 | Jan 26, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | NISOLDIPINE | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 091001-002 | Jan 26, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-008 | Jan 2, 2008 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-003 | Feb 2, 1995 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan | NISOLDIPINE | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 091001-003 | Jan 26, 2011 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-001 | Feb 2, 1995 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan | NISOLDIPINE | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 079051-003 | Jul 25, 2008 | RX | No | 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 NISOLDIPINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-006 | Jan 2, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-001 | Feb 2, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-002 | Feb 2, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-003 | Feb 2, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-005 | Jan 2, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-008 | Jan 2, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-006 | Jan 2, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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. 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.
ISSN: 2162-2639
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