Rifampin - Generic Drug Details

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

Rifampin is the generic ingredient in three branded drugs marketed by Sanofi Aventis Us, Chartwell Molecular, Epic Pharma Llc, Hikma, Lupin Pharms, Oxford Pharms, Avet Lifesciences, Fresenius Kabi Usa, Hikma Pharms, Mylan Labs Ltd, and Watson Pharms Teva, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for rifampin. Fifteen suppliers are listed for this compound.

Sponsor	Phase
Hôpital Necker-Enfants Malades	Phase 3
Institut Pasteur	Phase 3
Centre Hospitalier Universitaire de Caen	Phase 3

Sponsor

Phase

Hôpital Necker-Enfants Malades

Phase 3

Institut Pasteur

Phase 3

Centre Hospitalier Universitaire de Caen

Phase 3

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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
Sanofi Aventis Us	RIFADIN	rifampin	INJECTABLE;INJECTION	050627-001	May 25, 1989	AP	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	RIFAMPIN	rifampin	CAPSULE;ORAL	065028-001	Mar 14, 2001	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Pharms Teva	RIFAMPIN	rifampin	INJECTABLE;INJECTION	206736-001	Jan 19, 2016		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Pharms	RIFAMPIN	rifampin	CAPSULE;ORAL	090034-001	Aug 21, 2013	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma Pharms	RIFAMPIN	rifampin	INJECTABLE;INJECTION	205039-001	Mar 3, 2016	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Pharms	RIFAMPIN	rifampin	CAPSULE;ORAL	090034-002	Aug 21, 2013	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Epic Pharma Llc	RIFAMPIN	rifampin	INJECTABLE;INJECTION	065502-001	Sep 21, 2010	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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:	3
Applicants:	11
NDAs:	15
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	306
Patent Applications:	7,295
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for rifampin
What excipients (inactive ingredients) are in rifampin?	rifampin excipients list
DailyMed Link:	rifampin at DailyMed