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.

Summary for hydroxychloroquine sulfate

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

Drug Sales Revenue Trends for hydroxychloroquine sulfate

See drug sales revenues for hydroxychloroquine sulfate

Recent Clinical Trials for hydroxychloroquine sulfate

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

Sponsor	Phase
Henan Cancer Hospital	Phase 2
West Virginia University	Phase 1/Phase 2
Abramson Cancer Center of the University of Pennsylvania	Phase 2

See all hydroxychloroquine sulfate clinical trials

Pharmacology for hydroxychloroquine sulfate

Drug Class	Antimalarial Antirheumatic Agent

Medical Subject Heading (MeSH) Categories for hydroxychloroquine sulfate

Antimalarials
Antirheumatic Agents
Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for hydroxychloroquine sulfate

P01BA	Aminoquinolines
P01B	ANTIMALARIALS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

P01BA	Aminoquinolines
P01B	ANTIMALARIALS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for hydroxychloroquine sulfate

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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
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
>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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