Nimodipine - Generic Drug Details
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What are the generic sources for nimodipine and what is the scope of freedom to operate?
Nimodipine
is the generic ingredient in three branded drugs marketed by Bionpharma, Heritage, Sofgen Pharms, Sun Pharm Inds Inc, Thepharmanetwork Llc, Bayer Pharms, Annora Pharma, and Azurity, and is included in eight NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Nimodipine has two patent family members in two countries.
There are eight drug master file entries for nimodipine. Four suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for nimodipine
International Patents: | 2 |
US Patents: | 6 |
Tradenames: | 3 |
Applicants: | 8 |
NDAs: | 8 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 125 |
Clinical Trials: | 46 |
Patent Applications: | 6,919 |
Drug Prices: | Drug price trends for nimodipine |
What excipients (inactive ingredients) are in nimodipine? | nimodipine excipients list |
DailyMed Link: | nimodipine at DailyMed |
Recent Clinical Trials for nimodipine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Xiaolin Chen, MD | Phase 2/Phase 3 |
Acasti Pharma Inc. | Phase 3 |
Affiliated hospital of jining medical college | Phase 3 |
Generic filers with tentative approvals for NIMODIPINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 60MG/10ML | SOLUTION;ORAL |
⤷ Sign Up | ⤷ Sign Up | 30MG/5ML | SOLUTION;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for nimodipine
Drug Class | Dihydropyridine Calcium Channel Blocker |
Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for nimodipine
Anatomical Therapeutic Chemical (ATC) Classes for nimodipine
Paragraph IV (Patent) Challenges for NIMODIPINE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
NYMALIZE | Oral Solution | nimodipine | 6 mg/mL | 203340 | 1 | 2021-11-29 |
US Patents and Regulatory Information for nimodipine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bayer Pharms | NIMOTOP | nimodipine | CAPSULE;ORAL | 018869-001 | Dec 28, 1988 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Heritage | NIMODIPINE | nimodipine | CAPSULE;ORAL | 077811-001 | May 2, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Azurity | NYMALIZE | nimodipine | SOLUTION;ORAL | 203340-002 | Apr 8, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 nimodipine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Pharms | NIMOTOP | nimodipine | CAPSULE;ORAL | 018869-001 | Dec 28, 1988 | ⤷ Sign Up | ⤷ Sign Up |
Azurity | NYMALIZE | nimodipine | SOLUTION;ORAL | 203340-002 | Apr 8, 2020 | ⤷ Sign Up | ⤷ Sign Up |
Azurity | NYMALIZE | nimodipine | SOLUTION;ORAL | 203340-002 | Apr 8, 2020 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for nimodipine
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 03093108 | ⤷ Sign Up | |
Australia | 2003221794 | DISPENSER FOR MEDICAMENTS AND METHOD AND APPARATUS FOR MAKING SAME | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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