NYMALIZE Drug Patent Profile
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When do Nymalize patents expire, and when can generic versions of Nymalize launch?
Nymalize is a drug marketed by Azurity and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has two patent family members in two countries.
The generic ingredient in NYMALIZE is nimodipine. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nimodipine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nymalize
A generic version of NYMALIZE was approved as nimodipine by HERITAGE PHARMS on May 2nd, 2007.
Summary for NYMALIZE
International Patents: | 2 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 124 |
Clinical Trials: | 1 |
Patent Applications: | 4,146 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for NYMALIZE |
What excipients (inactive ingredients) are in NYMALIZE? | NYMALIZE excipients list |
DailyMed Link: | NYMALIZE at DailyMed |


Recent Clinical Trials for NYMALIZE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Johns Hopkins University | Early Phase 1 |
Pharmacology for NYMALIZE
Drug Class | Dihydropyridine Calcium Channel Blocker |
Mechanism of Action | Calcium Channel Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for NYMALIZE
Paragraph IV (Patent) Challenges for NYMALIZE
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 NYMALIZE
NYMALIZE is protected by seven US patents.
Patents protecting NYMALIZE
Non-aqueous liquid nimodipine compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR THE IMPROVEMENT OF NEUROLOGICAL OUTCOME BY REDUCING THE INCIDENCE AND SEVERITY OF ISCHEMIC DEFICITS IN ADULT PATIENTS WITH SUBARACHNOID HEMORRHAGE (SAH) FROM RUPTURED INTRACRANIAL BERRY ANEURYSMS
Non-aqueous liquid nimodipine compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR THE IMPROVEMENT OF NEUROLOGICAL OUTCOME BY REDUCING THE INCIDENCE AND SEVERITY OF ISCHEMIC DEFICITS IN ADULT PATIENTS WITH SUBARACHNOID HEMORRHAGE (SAH) FROM RUPTURED INTRACRANIAL BERRY ANEURYSMS
Non-aqueous liquid nimodipine compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR THE IMPROVEMENT OF NEUROLOGICAL OUTCOME BY REDUCING THE INCIDENCE AND SEVERITY OF ISCHEMIC DEFICITS IN ADULT PATIENTS WITH SUBARACHNOID HEMORRHAGE (SAH) FROM RUPTURED INTRACRANIAL BERRY ANEURYSMS
Non-aqueous liquid nimodipine compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR THE IMPROVEMENT OF NEUROLOGICAL OUTCOME BY REDUCING THE INCIDENCE AND SEVERITY OF ISCHEMIC DEFICITS IN ADULT PATIENTS WITH SUBARACHNOID HEMORRHAGE (SAH) FROM RUPTURED INTRACRANIAL BERRY ANEURYSMS
Liquid nimodipine compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dispenser for medicaments and method and apparatus for making same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dispenser for medicaments and method and apparatus for making same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Azurity | NYMALIZE | nimodipine | SOLUTION;ORAL | 203340-001 | May 10, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Azurity | NYMALIZE | nimodipine | SOLUTION;ORAL | 203340-002 | Apr 8, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Azurity | NYMALIZE | nimodipine | SOLUTION;ORAL | 203340-002 | Apr 8, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Azurity | NYMALIZE | nimodipine | SOLUTION;ORAL | 203340-002 | Apr 8, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Azurity | NYMALIZE | nimodipine | SOLUTION;ORAL | 203340-002 | Apr 8, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Azurity | NYMALIZE | nimodipine | SOLUTION;ORAL | 203340-002 | Apr 8, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Azurity | NYMALIZE | nimodipine | SOLUTION;ORAL | 203340-002 | Apr 8, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
International Patents for NYMALIZE
See the table below for patents covering NYMALIZE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2003221794 | DISPENSER FOR MEDICAMENTS AND METHOD AND APPARATUS FOR MAKING SAME | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 03093108 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |