POTASSIUM CITRATE - Generic Drug Details

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

Potassium citrate is the generic ingredient in two branded drugs marketed by Ut Sw Medctr, Ani Pharms, Ascent Pharms Inc, Bionpharma, Hibrow Hlthcare, Rising, Strides Pharma, Teva Pharms Usa Inc, Torrent, Zydus Pharms, and Mission Pharma, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for potassium citrate. Sixteen suppliers are listed for this compound.

Sponsor	Phase
Albert Einstein College of Medicine	Phase 2/Phase 3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2/Phase 3
University of Utah	Phase 2/Phase 3

Sponsor

Phase

Albert Einstein College of Medicine

Phase 2/Phase 3

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Phase 2/Phase 3

University of Utah

Phase 2/Phase 3

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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
Zydus Pharms	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	203546-001	Aug 6, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	077440-001	Jun 9, 2006	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	077440-002	Jun 9, 2006	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ascent Pharms Inc	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	214420-003	Feb 5, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	206813-003	Sep 11, 2017	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:	11
NDAs:	11
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	62
Patent Applications:	5,709
Drug Prices:	Drug price trends for POTASSIUM CITRATE
What excipients (inactive ingredients) are in POTASSIUM CITRATE?	POTASSIUM CITRATE excipients list
DailyMed Link:	POTASSIUM CITRATE at DailyMed

Drug Class	Anti-coagulant Calculi Dissolution Agent
Mechanism of Action	Acidifying Activity Calcium Chelating Activity
Physiological Effect	Decreased Coagulation Factor Activity