DICLOXACILLIN SODIUM - Generic Drug Details

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What are the generic sources for dicloxacillin sodium and what is the scope of freedom to operate?

Dicloxacillin sodium is the generic ingredient in four branded drugs marketed by Aurobindo Pharma, Chartwell Rx, Teva, Glaxosmithkline, Wyeth Ayerst, and Apothecon, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for dicloxacillin sodium. Eight suppliers are listed for this compound.

Summary for DICLOXACILLIN SODIUM

US Patents:	0
Tradenames:	4
Applicants:	6
NDAs:	9
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	1
Patent Applications:	1,683
What excipients (inactive ingredients) are in DICLOXACILLIN SODIUM?	DICLOXACILLIN SODIUM excipients list
DailyMed Link:	DICLOXACILLIN SODIUM at DailyMed

Recent Clinical Trials for DICLOXACILLIN SODIUM

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

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all DICLOXACILLIN SODIUM clinical trials

Pharmacology for DICLOXACILLIN SODIUM

Drug Class	Penicillin-class Antibacterial

Medical Subject Heading (MeSH) Categories for DICLOXACILLIN SODIUM

Anti-Bacterial Agents

US Patents and Regulatory Information for DICLOXACILLIN SODIUM

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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
Wyeth Ayerst	PATHOCIL	dicloxacillin sodium	CAPSULE;ORAL	050011-003	Mar 28, 1983		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	DYCILL	dicloxacillin sodium	CAPSULE;ORAL	060254-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	DICLOXACILLIN SODIUM	dicloxacillin sodium	CAPSULE;ORAL	061454-002	Approved Prior to Jan 1, 1982		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

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