HYDROXYCHLOROQUINE SULFATE Drug Patent Profile

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Hydroxychloroquine Sulfate is a drug 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, and Zydus Pharms Usa Inc. and is included in fifteen NDAs.

The generic ingredient in HYDROXYCHLOROQUINE SULFATE is hydroxychloroquine sulfate. There are fifteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.

A generic version of HYDROXYCHLOROQUINE SULFATE was approved as hydroxychloroquine sulfate by TEVA PHARMS on September 30^th, 1994.

US Patents:	0
Applicants:	15
NDAs:	15
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	46
Patent Applications:	2,618
Formulation / Manufacturing:	see details
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

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

Sponsor	Phase
Henan Cancer Hospital	Phase 2
West Virginia University	Phase 1/Phase 2
Breast Cancer Research Foundation	Phase 2

Drug Class	Antimalarial Antirheumatic Agent

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

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

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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
Accord Hlthcare	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	213342-002	Aug 18, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Senores Pharms	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	212902-001	May 14, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Appco	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	210441-002	Sep 19, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Accord Hlthcare	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	213342-004	Aug 18, 2021	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chartwell Rx	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	210543-001	Jul 6, 2018	AB	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