Hydroxychloroquine sulfate - Generic Drug Details

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

Hydroxychloroquine sulfate is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Alkaloida Zrt, Amneal Pharms Co, Appco, Aurobindo Pharma Usa, Chartwell Rx, Creekwood Pharms, Hikma Pharms, Ipca Labs Ltd, Laurus, Sandoz, Senores Pharms, Teva Pharms, Watson Labs, Zydus Pharms Usa Inc, Concordia, and Novitium Pharma, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for hydroxychloroquine sulfate. Twenty-eight suppliers are listed for this compound.

Sponsor

Phase

Henan Cancer Hospital

Phase 2

West Virginia University

Phase 1/Phase 2

Pfizer

Phase 2

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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
Hikma Pharms	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	040760-001	Aug 15, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Laurus	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	210959-001	Jan 15, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novitium Pharma	SOVUNA	hydroxychloroquine sulfate	TABLET;ORAL	214581-001	Jan 14, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Appco	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	210441-003	Sep 19, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Usa	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	040274-001	May 29, 1998	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Creekwood Pharms	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	040150-001	Jan 27, 1996	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Appco	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	210441-001	May 1, 2018	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

US Patents:	0
Tradenames:	3
Applicants:	17
NDAs:	17
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	46
Patent Applications:	3,696
Drug Sales Revenues:	Drug sales revenues for hydroxychloroquine sulfate
What excipients (inactive ingredients) are in hydroxychloroquine sulfate?	hydroxychloroquine sulfate excipients list
DailyMed Link:	hydroxychloroquine sulfate at DailyMed