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:	7,118
Drug Prices:	Drug price trends for NIMODIPINE
What excipients (inactive ingredients) are in NIMODIPINE?	NIMODIPINE excipients list
DailyMed Link:	NIMODIPINE at DailyMed

See drug prices for NIMODIPINE

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
Shanghai Canming Pharmaceutical Technology Co., Ltd	Phase 3

See all NIMODIPINE clinical trials

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

Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for NIMODIPINE

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

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

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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	203340-002	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
Bayer Pharms	NIMOTOP	nimodipine	CAPSULE;ORAL	018869-001	Dec 28, 1988		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-001	May 10, 2013		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
Sofgen Pharms	NIMODIPINE	nimodipine	CAPSULE;ORAL	201832-001	Jul 24, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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

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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
Bayer Pharms	NIMOTOP	nimodipine	CAPSULE;ORAL	018869-001	Dec 28, 1988	⤷ Sign Up	⤷ Sign Up
Bayer Pharms	NIMOTOP	nimodipine	CAPSULE;ORAL	018869-001	Dec 28, 1988	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for NIMODIPINE

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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

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