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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Fresenius Medcl | PHOSLYRA | calcium acetate | SOLUTION;ORAL | 022581-001 | Apr 18, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 | |||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Fresenius Medcl | PHOSLO | calcium acetate | CAPSULE;ORAL | 021160-001 | Apr 2, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Fresenius Medcl | PHOSLO | calcium acetate | CAPSULE;ORAL | 021160-002 | Apr 2, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>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) | ⤷ Sign Up |
Spain | 2382993 | ⤷ Sign Up | |
Mexico | 2009000722 | COMPOSICIONES LIQUIDAS DE ACETATO DE CALCIO. (LIQUID COMPOSITIONS OF CALCIUM ACETATE.) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CALCIUM ACETATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2365988 | 2018C/006 | Belgium | ⤷ Sign Up | PRODUCT NAME: PATIROMER SORBITEX CALCIUM OF EERDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721 |
2957286 | CA 2018 00043 | Denmark | ⤷ Sign Up | PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721 |
2957286 | 132019000000021 | Italy | ⤷ Sign Up | PRODUCT NAME: PATIROMER SORBITEX CALCIUM E QUALSIASI SUO SALE O DERIVATO(VELTASSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1179, 20170721 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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