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, Leading, Teva, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Usa, Elite Pharm Solution, Martec Usa Llc, Mylan, Novast Labs, Osmotica Pharm Us, Par Pharm, Rising, Spil, Twi Pharms, Valeant Pharms North, Vitruvias, 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 September 20th, 1990.
Summary for NIFEDIPINE
US Patents: | 0 |
Applicants: | 22 |
NDAs: | 30 |
Finished Product Suppliers / Packagers: | 35 |
Raw Ingredient (Bulk) Api Vendors: | 165 |
Clinical Trials: | 164 |
Patent Applications: | 3,740 |
Formulation / Manufacturing: | see details |
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 |
Recent Clinical Trials for NIFEDIPINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Queen Mary University of London | N/A |
Medical College of Wisconsin | Phase 3 |
Shaheed Zulfiqar Ali Bhutto Medical University | N/A |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Osmotica Pharm Us | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 077127-001 | Nov 21, 2005 | AB2 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Twi Pharms | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 203126-003 | Apr 3, 2014 | AB2 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Zydus Pharms | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 210184-002 | Jun 29, 2018 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |