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, Eywa, 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. Seventeen suppliers are listed for this compound.

Sponsor	Phase
TenNor Therapeutics (Suzhou) Limited	Phase 3
Joshua Stern	Early Phase 1
Albert Einstein College of Medicine	Early Phase 1

Sponsor

Phase

TenNor Therapeutics (Suzhou) Limited

Phase 3

Joshua Stern

Early Phase 1

Albert Einstein College of Medicine

Early Phase 1

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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
Torrent	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	213986-002	Feb 6, 2024		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Pharms Usa Inc	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	209758-001	Mar 5, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	077440-001	Jun 9, 2006	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ascent Pharms Inc	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	214420-001	Feb 5, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ani Pharms	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	212779-002	Jan 14, 2020	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

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	60
Patent Applications:	5,709
Formulation / Manufacturing:	see details
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