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-two 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:	22
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	41
Patent Applications:	8,410
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
Peking University People's Hospital	Phase 2
Mark Fox	Phase 4
University of Colorado, Denver	Phase 2

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

Anatomical Therapeutic Chemical (ATC) Classes for CALCIUM ACETATE

V03AE	Drugs for treatment of hyperkalemia and hyperphosphatemia
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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
Suven Pharms	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	211038-001	Feb 21, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Square Pharms	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	217205-001	Mar 13, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lotus Pharm Co Ltd	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	203298-001	Jul 26, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nostrum Labs Inc	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	203179-001	Oct 26, 2015	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

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	CAPSULE;ORAL	021160-001	Apr 2, 2001	⤷ Sign Up	⤷ Sign Up
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	⤷ Sign Up	⤷ Sign Up
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	⤷ Sign Up	⤷ Sign Up
Fresenius Medcl	PHOSLO	calcium acetate	TABLET;ORAL	019976-001	Dec 10, 1990	⤷ Sign Up	⤷ Sign Up
>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
China	104095838	Liquid compositions of calcium acetate	⤷ Sign Up
Canada	2658465	COMPOSITIONS LIQUIDES D'ACETATE DE CALCIUM (LIQUID COMPOSITIONS OF CALCIUM ACETATE)	⤷ Sign Up
China	101522021	Liquid compositions of calcium acetate	⤷ Sign Up
Australia	2007275606	Liquid compositions of calcium acetate	⤷ Sign Up
>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
0720599	122014000088	Germany	⤷ Sign Up	PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT ATORVASTATIN ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE ATORVASTATIN ALS ATORVASTATINCALCIUMTRIHYDRAT; NAT. REGISTRATION NO/DATE: 90223.00.00 20141113; FIRST REGISTRATION: FRANKREICH CIS: 6 928 917 6 20140912
2365988	CA 2018 00006	Denmark	⤷ Sign Up	PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
0521471	SPC/GB03/033	United Kingdom	⤷ Sign Up	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
0933372	13/2008	Austria	⤷ Sign Up	PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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