Nafcillin sodium - Generic Drug Details

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What are the generic drug sources for nafcillin sodium and what is the scope of patent protection?

Nafcillin sodium is the generic ingredient in five branded drugs marketed by Wyeth Ayerst, Antibiotice, Apothecon, Eugia Pharma Speclts, Fresenius, Istituto Bio Ita Spa, Onesource Specialty, Sagent Pharms, Sandoz, Watson Labs Inc, Glaxosmithkline, and Baxter Hlthcare, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for nafcillin sodium. Eleven suppliers are listed for this compound.

Sponsor

Phase

Federal University of São Paulo

Phase 4

Fundação de Amparo à Pesquisa do Estado de São Paulo

Phase 4

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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	UNIPEN	nafcillin sodium	INJECTABLE;INJECTION	062717-004	Dec 16, 1986		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Fresenius	NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	206682-001	Dec 10, 2019		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sagent Pharms	NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	090580-001	Aug 24, 2012	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sandoz	NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	062527-002	Aug 2, 1984		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Baxter Hlthcare	NALLPEN IN PLASTIC CONTAINER	nafcillin sodium	INJECTABLE;INJECTION	050655-002	Oct 31, 1989		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Wyeth Ayerst	UNIPEN	nafcillin sodium	INJECTABLE;INJECTION	050320-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sandoz	NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	062732-002	Dec 23, 1986		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	5
Applicants:	12
NDAs:	23
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	1,763
What excipients (inactive ingredients) are in nafcillin sodium?	nafcillin sodium excipients list
DailyMed Link:	nafcillin sodium at DailyMed