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 six 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. Four 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 on May 2^nd, 2007.

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Summary for NYMALIZE

International Patents:	2
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	1
Patent Applications:	5,129
Drug Prices:	Drug price information for NYMALIZE
What excipients (inactive ingredients) are in NYMALIZE?	NYMALIZE excipients list
DailyMed Link:	NYMALIZE at DailyMed

Drug patent expirations by year for NYMALIZE

Recent Clinical Trials for NYMALIZE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Johns Hopkins University	Early Phase 1

See all NYMALIZE clinical trials

Pharmacology for NYMALIZE

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists

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 six US patents.

Patents protecting NYMALIZE

Non-aqueous liquid nimodipine compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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

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Patent Expiration: ⤷ Sign Up

Dispenser for medicaments and method and apparatus for making same
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Glossary

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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	⤷ 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
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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 NYMALIZE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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 NYMALIZE

See the table below for patents covering NYMALIZE around the world.

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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