QUININE SULFATE - Generic Drug Details

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What are the generic sources for quinine sulfate and what is the scope of patent protection?

Quinine sulfate is the generic ingredient in two branded drugs marketed by Sun Pharm Industries, Amneal Pharms, Aurobindo Pharma Usa, Lupin Ltd, Novast Labs, and Teva Pharms, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for quinine sulfate. Five suppliers are listed for this compound.

Sponsor	Phase
Hiroshi Mitsumoto	Phase 1/Phase 2
National Research and Innovation Agency of Indonesia	N/A
Universitas Padjadjaran	N/A

Sponsor

Phase

Hiroshi Mitsumoto

Phase 1/Phase 2

National Research and Innovation Agency of Indonesia

N/A

Universitas Padjadjaran

N/A

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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
Sun Pharm Industries	QUALAQUIN	quinine sulfate	CAPSULE;ORAL	021799-001	Aug 12, 2005		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novast Labs	QUININE SULFATE	quinine sulfate	CAPSULE;ORAL	204372-001	Jul 22, 2015	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	QUININE SULFATE	quinine sulfate	CAPSULE;ORAL	203112-001	Apr 24, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Usa	QUININE SULFATE	quinine sulfate	CAPSULE;ORAL	202581-001	Dec 14, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	QUININE SULFATE	quinine sulfate	CAPSULE;ORAL	203729-001	Jul 15, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms	QUININE SULFATE	quinine sulfate	CAPSULE;ORAL	091661-001	Sep 28, 2012	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:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	205
Clinical Trials:	17
Patent Applications:	4,860
Drug Prices:	Drug price trends for QUININE SULFATE
What excipients (inactive ingredients) are in QUININE SULFATE?	QUININE SULFATE excipients list
DailyMed Link:	QUININE SULFATE at DailyMed