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 |
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 |
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
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fresenius Medcl | PHOSLYRA | calcium acetate | SOLUTION;ORAL | 022581-001 | Apr 18, 2011 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Fresenius Medcl | PHOSLYRA | calcium acetate | SOLUTION;ORAL | 022581-001 | Apr 18, 2011 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Hikma | CALCIUM ACETATE | calcium acetate | CAPSULE;ORAL | 077728-001 | Feb 26, 2008 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Cypress Pharm | ELIPHOS | calcium acetate | TABLET;ORAL | 078502-001 | Nov 25, 2008 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Fresenius Medcl | PHOSLO GELCAPS | calcium acetate | CAPSULE;ORAL | 021160-003 | Apr 2, 2001 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Heritage Pharms Inc | CALCIUM ACETATE | calcium acetate | TABLET;ORAL | 202885-001 | Jan 22, 2015 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Fresenius Medcl | PHOSLO GELCAPS | calcium acetate | CAPSULE;ORAL | 021160-003 | Apr 2, 2001 | ⤷ Subscribe | ⤷ Subscribe |
Fresenius Medcl | PHOSLO | calcium acetate | CAPSULE;ORAL | 021160-001 | Apr 2, 2001 | ⤷ Subscribe | ⤷ Subscribe |
Fresenius Medcl | PHOSLO | calcium acetate | TABLET;ORAL | 019976-001 | Dec 10, 1990 | ⤷ Subscribe | ⤷ Subscribe |
Fresenius Medcl | PHOSLO GELCAPS | calcium acetate | CAPSULE;ORAL | 021160-003 | Apr 2, 2001 | ⤷ Subscribe | ⤷ Subscribe |
Fresenius Medcl | PHOSLO GELCAPS | calcium acetate | CAPSULE;ORAL | 021160-003 | Apr 2, 2001 | ⤷ Subscribe | ⤷ Subscribe |
Fresenius Medcl | PHOSLO | calcium acetate | CAPSULE;ORAL | 021160-002 | Apr 2, 2001 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CALCIUM ACETATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2484352 | Compositions liquides d'acétate de calcium (Liquid compositions of calcium acetate) | ⤷ Subscribe |
South Korea | 101553719 | ⤷ Subscribe | |
Poland | 2484352 | ⤷ Subscribe | |
Hong Kong | 1202815 | 醋酸鈣的液體組合物 (LIQUID COMPOSITIONS OF CALCIUM ACETATE) | ⤷ Subscribe |
South Africa | 200900472 | Liquid compositions of calcium acetate | ⤷ Subscribe |
Brazil | PI0714882 | composiÇço lÍquida de acetato de cÁlcio e uso de uma soluÇço aquosa que compreende entre cerca de 7% (p/v) e cerca de 21% (p/v) de acetato de cÁlcio | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CALCIUM ACETATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2957286 | 300962 | Netherlands | ⤷ Subscribe | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721 |
2365988 | 2018C/006 | Belgium | ⤷ Subscribe | PRODUCT NAME: PATIROMER SORBITEX CALCIUM OF EERDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721 |
0933372 | PA2008006,C0933372 | Lithuania | ⤷ Subscribe | PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712 |
2957286 | 1990003-4 | Sweden | ⤷ Subscribe | PRODUCT NAME: PATRIOMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179 20170721 |
2365988 | LUC00061 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: PATIROMER SORBITEX CALCIUM ET TOUS LES SELS ET DERIVES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721 |
2957286 | SPC/GB19/003 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTERED: UK EU/1/17/1179/001(NI) 20170721; UK EU/1/17/1179/002(NI) 20170721; UK EU/1/17/1179/003(NI) 20170721; UK EU/1/17/1179/004(NI) 20170721; UK EU/1/17/1179/005(NI) 20170721; UK EU/1/17/1179/006(NI) 20170721; UK EU/1/17/1179/007(NI) 20170721; UK EU/1/17/1179/008(NI) 20170721; UK EU/1/17/1179/009(NI) 20170721; UK PLGB 50784/0002-0001 20170721; UK PLGB 50784/0003-0001 20170721; UK PLGB 50784/0004-0001 20170721 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
CALCIUM ACETATE Market Analysis and Financial Projection Experimental
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