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Details for Patent: 8,076,362

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Patent 8,076,362 protects BANZEL and is included in one NDA. There have been two Paragraph IV challenges on Banzel.

Protection for BANZEL has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

Summary for Patent: 8,076,362

Title:Crystal modification A of 1-(2,6-difluorobenzyI)-1 H-1,2,3-triazole-4-carboxamide and dosage forms and formulations thereof
Abstract: The invention relates to dosage forms and formulations comprising the novel crystal modification A of the compound I-(2,6-difluorobenzyl)-I H-I,2,3-triazole-4-carboxamide, wherein crystal modification A is characterized by characteristic lines with interplanar spacings (d values) of 10.5 .ANG., 5.14 .ANG., 4.84 .ANG., 4.55 .ANG., 4.34 .ANG., 4.07 .ANG., 3.51 .ANG., 3.48 .ANG., 3.25 .ANG., 3.19 .ANG., 3.15 .ANG., 3.07 .ANG., and 2.81 .ANG., determined by means of an X-ray powder pattern. Dosage forms of crystal modification A of the compound I-(2,6-difluorobenzyl)-I H-I,2,3-triazole-4-carboxamide may be for oral or parenteral administration, in the form of a solid or liquid, and in a dosage range of 20 mg to less than 500 mg. Solid dosage forms comprise a tablet or capsule, and further comprise a pharmaceutically-acceptable carrier and film-coat.
Inventor(s): Portmann; Robert (Pratteln, CH), Hofmeier; Urs Christoph (St. Pantaleon, CH), Burkhard; Andreas (Basel, CH), Scherrer; Walter (Rheinfelden, CH), Szelagiewicz; Martin (Munchenstein, CH)
Assignee: Novartis AG (Basel, CH)
Application Number:12/767,003
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 18th percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Eisai Inc
BANZEL
rufinamide
TABLET;ORAL021911-001Nov 14, 2008DISCNNo8,076,362*PED► subscribeY
Eisai Inc
BANZEL
rufinamide
TABLET;ORAL021911-002Nov 14, 2008RXNo8,076,362*PED► subscribeY
Eisai Inc
BANZEL
rufinamide
TABLET;ORAL021911-003Nov 14, 2008RXYes8,076,362*PED► subscribeY
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Foreign Priority and PCT Information for Patent: 8,076,362

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Switzerland1404/97Jun 10, 1997

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