NISOLDIPINE Drug Patent Profile
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Which patents cover Nisoldipine, and when can generic versions of Nisoldipine launch?
Nisoldipine is a drug marketed by Amta and Mylan and is included in three NDAs.
The generic ingredient in NISOLDIPINE is nisoldipine. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nisoldipine
A generic version of NISOLDIPINE was approved as nisoldipine by MYLAN on July 25th, 2008.
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Questions you can ask:
- What is the 5 year forecast for NISOLDIPINE?
- What are the global sales for NISOLDIPINE?
- What is Average Wholesale Price for NISOLDIPINE?
Summary for NISOLDIPINE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 117 |
| Clinical Trials: | 6 |
| Patent Applications: | 4,812 |
| Drug Prices: | Drug price information 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amta | NISOLDIPINE | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 216606-001 | Apr 10, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| 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 | 079051-001 | Jul 25, 2008 | RX | No | Yes | ⤷ 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 | ||||
| Mylan | NISOLDIPINE | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 091001-001 | Jan 26, 2011 | AB | RX | No | No | ⤷ 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 |
