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Last Updated: May 7, 2024

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CALCIUM ACETATE - Generic Drug Details

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

Calcium acetate is the generic ingredient in five branded drugs marketed by Amneal Pharms, Chartwell Rx, Heritage Pharms Inc, Hikma, Invagen Pharms, Lotus Pharm Co Ltd, Lupin Ltd, Nostrum Labs Inc, Square Pharms, Suven Pharms, Fresenius Medcl, Chartwell Molecular, Padagis Us, and Cypress Pharm, and is included in eighteen NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Calcium acetate has twenty-three patent family members in sixteen countries.

There are six drug master file entries for calcium acetate. Twenty suppliers are listed for this compound.

Summary for CALCIUM ACETATE

International Patents:	23
US Patents:	3
Tradenames:	5
Applicants:	14
NDAs:	18
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	40
Patent Applications:	8,410
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for CALCIUM ACETATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CALCIUM ACETATE
What excipients (inactive ingredients) are in CALCIUM ACETATE?	CALCIUM ACETATE excipients list
DailyMed Link:	CALCIUM ACETATE at DailyMed

See drug prices for CALCIUM ACETATE

Drug Sales Revenue Trends for CALCIUM ACETATE

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Recent Clinical Trials for CALCIUM ACETATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mark Fox	Phase 4
University of Colorado, Denver	Phase 2
National Cheng-Kung University Hospital	N/A

See all CALCIUM ACETATE clinical trials

Pharmacology for CALCIUM ACETATE

Drug Class	Blood Coagulation Factor Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity
Physiological Effect	Increased Coagulation Factor Activity

Paragraph IV (Patent) Challenges for CALCIUM ACETATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PHOSLYRA	Oral Solution	calcium acetate	667 mg/5 mL	022581	2	2013-12-05
PHOSLO GELCAPS	Capsules	calcium acetate	EQ 169 mg calcium	021160	1	2005-05-31

US Patents and Regulatory Information for CALCIUM ACETATE

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Glossary

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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
Padagis Us	CALCIUM ACETATE	calcium acetate	TABLET;ORAL	091561-001	Apr 13, 2011	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lotus Pharm Co Ltd	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	203298-001	Jul 26, 2016		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fresenius Medcl	PHOSLYRA	calcium acetate	SOLUTION;ORAL	022581-001	Apr 18, 2011		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Square Pharms	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	217205-001	Mar 13, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	202127-001	Jul 9, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	077728-001	Feb 26, 2008	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fresenius Medcl	PHOSLO	calcium acetate	TABLET;ORAL	019976-001	Dec 10, 1990		DISCN	Yes	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

Expired US Patents for CALCIUM ACETATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Medcl	PHOSLO	calcium acetate	TABLET;ORAL	019976-001	Dec 10, 1990	⤷ Try a Trial	⤷ Try a Trial
Fresenius Medcl	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-002	Apr 2, 2001	⤷ Try a Trial	⤷ Try a Trial
Fresenius Medcl	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-001	Apr 2, 2001	⤷ Try a Trial	⤷ Try a Trial
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	⤷ Try a Trial	⤷ Try a Trial
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	⤷ Try a Trial	⤷ Try a Trial
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	⤷ Try a Trial	⤷ Try a Trial
Fresenius Medcl	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-002	Apr 2, 2001	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for CALCIUM ACETATE

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Country	Patent Number	Title	Estimated Expiration
Japan	5335674		⤷ Try a Trial
Canada	2658465	COMPOSITIONS LIQUIDES D'ACETATE DE CALCIUM (LIQUID COMPOSITIONS OF CALCIUM ACETATE)	⤷ Try a Trial
Spain	2382993		⤷ Try a Trial
Russian Federation	2009104774	ЖИДКАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ) И СПОСОБ СВЯЗЫВАНИЯ ФОСФОРА В ЖЕЛУДОЧНО-КИШЕЧНОМ ТРАКТЕ	⤷ Try a Trial
South Korea	20090040340	LIQUID COMPOSITIONS OF CALCIUM ACETATE	⤷ Try a Trial
Hong Kong	1129814	LIQUID COMPOSITIONS OF CALCIUM ACETATE	⤷ Try a Trial
Australia	2007275606	Liquid compositions of calcium acetate	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CALCIUM ACETATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2957286	2018/046	Ireland	⤷ Try a Trial	PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
0521471	SPC/GB03/033	United Kingdom	⤷ Try a Trial	PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321
2957286	CA 2018 00043	Denmark	⤷ Try a Trial	PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
2365988	CA 2018 00006	Denmark	⤷ Try a Trial	PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
0521471	C300125	Netherlands	⤷ Try a Trial	PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
0933372	PA2008006,C0933372	Lithuania	⤷ Try a Trial	PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
2957286	C02957286/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66411 22.12.2017
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.