Potassium citrate - Generic Drug Details

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What are the generic sources for potassium citrate and what is the scope of patent protection?

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
University of Utah	Phase 2/Phase 3
Columbia University	Phase 2/Phase 3
University of Pittsburgh Medical Center	Phase 2/Phase 3

Sponsor

Phase

University of Utah

Phase 2/Phase 3

Columbia University

Phase 2/Phase 3

University of Pittsburgh Medical Center

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
Rising	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	077440-001	Jun 9, 2006	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Torrent	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	213986-003	Feb 6, 2024		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hibrow Hlthcare	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	214426-003	Feb 19, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	206813-001	Sep 11, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	206813-002	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