Zinc sulfate - Generic Drug Details

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

Zinc sulfate is the generic ingredient in one branded drug marketed by Abraxis Pharm, Am Regent, Apotex, Fresenius Kabi Usa, Gland Pharma Ltd, Nivagen Pharms Inc, Somerset Theraps Llc, and Zydus Pharms, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for zinc sulfate. Nine suppliers are listed for this compound.

Sponsor	Phase
Bellicum Pharmaceuticals	Phase 1/Phase 2
UNC Lineberger Comprehensive Cancer Center	Phase 1/Phase 2
University Cancer Research Fund at Lineberger Comprehensive Cancer Center	Phase 1/Phase 2

Sponsor

Phase

Bellicum Pharmaceuticals

Phase 1/Phase 2

UNC Lineberger Comprehensive Cancer Center

Phase 1/Phase 2

University Cancer Research Fund at Lineberger Comprehensive Cancer Center

Phase 1/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
Gland Pharma Ltd	ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	216249-002	May 3, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	217074-003	Aug 22, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	217074-001	Aug 22, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	209377-001	Jul 18, 2019	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Somerset Theraps Llc	ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	216135-002	Jul 17, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nivagen Pharms Inc	ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	214597-002	Jul 5, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland Pharma Ltd	ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	216249-003	Sep 1, 2023	AP	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:	1
Applicants:	8
NDAs:	8
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	1,080
Patent Applications:	3,727
Drug Sales Revenues:	Drug sales revenues for zinc sulfate
What excipients (inactive ingredients) are in zinc sulfate?	zinc sulfate excipients list
DailyMed Link:	zinc sulfate at DailyMed

Drug Class	Copper Absorption Inhibitor
Physiological Effect	Decreased Copper Ion Absorption