RUFINAMIDE - Generic Drug Details

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What are the generic drug sources for rufinamide and what is the scope of freedom to operate?

Rufinamide is the generic ingredient in two branded drugs marketed by Eisai Inc, Alkem Labs Ltd, Aurobindo Pharma, Bionpharma, Chartwell Rx, Hetero Labs Ltd Iii, Hikma, Lupin Ltd, Glenmark Pharms Ltd, Micro Labs, and Mylan, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for rufinamide. Twelve suppliers are listed for this compound.

Summary for RUFINAMIDE

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	16
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	12
Patent Applications:	1,609
Drug Prices:	Drug price trends for RUFINAMIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RUFINAMIDE
What excipients (inactive ingredients) are in RUFINAMIDE?	RUFINAMIDE excipients list
DailyMed Link:	RUFINAMIDE at DailyMed

See drug prices for RUFINAMIDE

Recent Clinical Trials for RUFINAMIDE

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

Sponsor	Phase
Bristol Royal Hospital for Children	Phase 4
National Institute for Health Research, United Kingdom	Phase 4
Alder Hey Children's NHS Foundation Trust	Phase 4

See all RUFINAMIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for RUFINAMIDE

N03AF	Carboxamide derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for RUFINAMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BANZEL	Oral Suspension	rufinamide	40 mg/mL	201367	1	2014-06-16
BANZEL	Tablets	rufinamide	200 mg and 400 mg	021911	5	2012-11-14

US Patents and Regulatory Information for RUFINAMIDE

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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
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-003	Nov 14, 2008	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd Iii	RUFINAMIDE	rufinamide	TABLET;ORAL	204993-002	May 11, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	RUFINAMIDE	rufinamide	TABLET;ORAL	204988-001	May 16, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bionpharma	RUFINAMIDE	rufinamide	SUSPENSION;ORAL	211388-001	Apr 23, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd Iii	RUFINAMIDE	rufinamide	TABLET;ORAL	204993-001	May 11, 2021	AB	RX	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 RUFINAMIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	BANZEL	rufinamide	SUSPENSION;ORAL	201367-001	Mar 3, 2011	⤷ Sign Up	⤷ Sign Up
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-001	Nov 14, 2008	⤷ Sign Up	⤷ Sign Up
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-001	Nov 14, 2008	⤷ Sign Up	⤷ Sign Up
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008	⤷ Sign Up	⤷ Sign Up
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for RUFINAMIDE

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eisai GmbH	Inovelon	rufinamide	EMEA/H/C/000660 Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years of age and older.	Authorised	no	no	no	2007-01-16
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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