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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
McKinsey
Healthtrust
McKesson
US Army
Harvard Business School
Medtronic
Federal Trade Commission
Johnson and Johnson
Julphar

Generated: December 13, 2017

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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 calcium acetate freedom to operate?

Calcium acetate
is the generic ingredient in five branded drugs marketed by Amneal Pharms, Chartwell Rx, Eci Pharms Llc, Heritage Pharms Inc, Invagen Pharms, Lupin Ltd, Nostrum Labs Inc, West-ward Pharms Int, Fresenius Medcl, Paddock Llc, and Cypress Pharm, and is included in sixteen NDAs. There are five 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 seventeen countries and eight supplementary protection certificates in five countries.

There are two hundred and seventy drug master file entries for calcium acetate. Thirty-four suppliers are listed for this compound.

Pharmacology for CALCIUM ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
West-ward Pharms IntCALCIUM ACETATEcalcium acetateTABLET;ORAL077693-001Jan 30, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Nostrum Labs IncCALCIUM ACETATEcalcium acetateCAPSULE;ORAL203179-001Oct 26, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Invagen PharmsCALCIUM ACETATEcalcium acetateCAPSULE;ORAL203135-001Feb 7, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius MedclPHOSLO GELCAPScalcium acetateCAPSULE;ORAL021160-003Apr 2, 2001ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius MedclPHOSLYRAcalcium acetateSOLUTION;ORAL022581-001Apr 18, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius MedclPHOSLYRAcalcium acetateSOLUTION;ORAL022581-001Apr 18, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Fresenius MedclPHOSLOcalcium acetateTABLET;ORAL019976-001Dec 10, 1990DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Lupin LtdCALCIUM ACETATEcalcium acetateCAPSULE;ORAL202127-001Jul 9, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Chartwell RxCALCIUM ACETATEcalcium acetateCAPSULE;ORAL091312-001Jun 1, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius MedclPHOSLOcalcium acetateCAPSULE;ORAL021160-001Apr 2, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: calcium acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius MedclPHOSLOcalcium acetateCAPSULE;ORAL021160-001Apr 2, 2001► Subscribe► Subscribe
Fresenius MedclPHOSLOcalcium acetateTABLET;ORAL019976-001Dec 10, 1990► Subscribe► Subscribe
Fresenius MedclPHOSLO GELCAPScalcium acetateCAPSULE;ORAL021160-003Apr 2, 2001► Subscribe► Subscribe
Fresenius MedclPHOSLOcalcium acetateCAPSULE;ORAL021160-002Apr 2, 2001► Subscribe► Subscribe
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International Patent Family for Ingredient: calcium acetate

Country Document Number Estimated Expiration
Israel196584► Subscribe
Russian Federation2463060► Subscribe
World Intellectual Property Organization (WIPO)2008011126► Subscribe
BrazilPI0714882► Subscribe
Japan5335674► Subscribe
Canada2658465► Subscribe
New Zealand574331► Subscribe
Australia2007275606► Subscribe
Russian Federation2009104774► Subscribe
China104095838► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: CALCIUM ACETATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00125Netherlands► SubscribePRODUCT 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
C/GB08/018United Kingdom► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
C/GB03/033United Kingdom► SubscribePRODUCT 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
2014 00050Denmark► SubscribePRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
2008006,C0933372Lithuania► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
/2008Austria► SubscribePRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
2008006Lithuania► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
/1997Austria► SubscribePRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
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Serving leading biopharmaceutical companies globally:

Colorcon
QuintilesIMS
Citi
Cantor Fitzgerald
Fuji
Dow
Deloitte
Federal Trade Commission
Express Scripts
Fish and Richardson

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 verifification 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.

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