Calcium acetate - Generic Drug Details
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What are the generic 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-one 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: | 21 |
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 |
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 | N/A |
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Chartwell Molecular | CALCIUM ACETATE | calcium acetate | TABLET;ORAL | 202420-001 | Feb 5, 2013 | AB | RX | No | Yes | ⤷ 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 | ||||
Fresenius Medcl | PHOSLO | calcium acetate | CAPSULE;ORAL | 021160-001 | Apr 2, 2001 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Fresenius Medcl | PHOSLO GELCAPS | calcium acetate | CAPSULE;ORAL | 021160-003 | Apr 2, 2001 | AB | RX | Yes | Yes | ⤷ 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 | |||
>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 | 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 | calcium acetate | TABLET;ORAL | 019976-001 | Dec 10, 1990 | ⤷ 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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for calcium acetate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hong Kong | 1129814 | LIQUID COMPOSITIONS OF CALCIUM ACETATE | ⤷ Try a Trial |
South Korea | 20090040340 | LIQUID COMPOSITIONS OF CALCIUM ACETATE | ⤷ Try a Trial |
European Patent Office | 2048948 | COMPOSITIONS LIQUIDES D'ACÉTATE DE CALCIUM (LIQUID COMPOSITIONS OF CALCIUM ACETATE) | ⤷ Try a Trial |
Russian Federation | 2463060 | ЖИДКАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ) И СПОСОБ СВЯЗЫВАНИЯ ФОСФОРА В ЖЕЛУДОЧНО-КИШЕЧНОМ ТРАКТЕ (LIQUID PHARMACEUTICAL COMPOSITION (VERSIONS) AND METHOD FOR PHOSPHOR BINDING IN GASTROINTESTINAL TRACT) | ⤷ Try a Trial |
Mexico | 2009000722 | COMPOSICIONES LIQUIDAS DE ACETATO DE CALCIO. (LIQUID COMPOSITIONS OF CALCIUM ACETATE.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for calcium acetate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2957286 | LUC00094 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721 |
2957286 | C02957286/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66411 22.12.2017 |
0720599 | 300689 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912 |
2365988 | LUC00061 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM ET TOUS LES SELS ET DERIVES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721 |
0933372 | PA2008006,C0933372 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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