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 five 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. Seven 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: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,425 |
| 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 |
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 five US patents.
Patents protecting NYMALIZE
Non-aqueous liquid nimodipine compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Dispenser for medicaments and method and apparatus for making same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Dispenser for medicaments and method and apparatus for making same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Azurity | NYMALIZE | nimodipine | SOLUTION;ORAL | 203340-002 | Apr 8, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Azurity | NYMALIZE | nimodipine | SOLUTION;ORAL | 203340-002 | Apr 8, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >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 | See Plans and Pricing |
| World Intellectual Property Organization (WIPO) | 03093108 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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