NIFEDIPINE Drug Patent Profile
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Which patents cover Nifedipine, and what generic alternatives are available?
Nifedipine is a drug marketed by Acella, Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Teva, Velzen Pharma Pvt, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Usa, Elite Pharm Solution, Endo Operations, Martec Usa Llc, Norvium Bioscience, Novast Labs, Osmotica Pharm Us, Rising, Spil, Swiss Pharm, Twi Pharms, Valeant Pharms North, and Zydus Pharms. and is included in thirty NDAs.
The generic ingredient in NIFEDIPINE is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nifedipine
A generic version of NIFEDIPINE was approved as nifedipine by ACTAVIS ELIZABETH on January 8th, 1991.
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Questions you can ask:
- What is the 5 year forecast for NIFEDIPINE?
- What are the global sales for NIFEDIPINE?
- What is Average Wholesale Price for NIFEDIPINE?
Summary for NIFEDIPINE
| US Patents: | 0 |
| Applicants: | 22 |
| NDAs: | 30 |
| Finished Product Suppliers / Packagers: | 35 |
| Raw Ingredient (Bulk) Api Vendors: | 165 |
| Clinical Trials: | 165 |
| Patent Applications: | 479 |
| Drug Prices: | Drug price information for NIFEDIPINE |
| Drug Sales Revenues: | Drug sales revenues for NIFEDIPINE |
| What excipients (inactive ingredients) are in NIFEDIPINE? | NIFEDIPINE excipients list |
| DailyMed Link: | NIFEDIPINE at DailyMed |
See drug prices for NIFEDIPINE
Recent Clinical Trials for NIFEDIPINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Marshall University | Phase 2 |
| Queen Mary University of London | N/A |
| Medical College of Wisconsin | Phase 3 |
Pharmacology for NIFEDIPINE
| Drug Class | Dihydropyridine Calcium Channel Blocker |
| Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for NIFEDIPINE
Anatomical Therapeutic Chemical (ATC) Classes for NIFEDIPINE
US Patents and Regulatory Information for NIFEDIPINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rising | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 201071-002 | Dec 3, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novast Labs | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 210614-002 | Mar 12, 2019 | AB2 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Twi Pharms | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 203126-001 | Apr 3, 2014 | AB2 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 210184-002 | Jun 29, 2018 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Spil | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 210838-002 | Apr 16, 2019 | AB2 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Twi Pharms | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 203126-002 | Apr 3, 2014 | AB2 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Valeant Pharms North | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 075289-001 | Sep 27, 2000 | AB2 | 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 |
