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
Translational Breast Cancer Research Consortium	Phase 2

Sponsor

Phase

Henan Cancer Hospital

Phase 2

West Virginia University

Phase 1/Phase 2

Translational Breast Cancer Research Consortium

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
Appco	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	210441-004	Sep 19, 2022	AB	RX	No	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
Amneal Pharms Co	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	210577-001	May 15, 2018	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
Accord Hlthcare	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	213342-001	Apr 7, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	040081-001	Sep 30, 1994	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Concordia	PLAQUENIL	hydroxychloroquine sulfate	TABLET;ORAL	009768-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes	⤷ 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