CALCIUM ACETATE Drug Patent Profile
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Which patents cover Calcium Acetate, and what generic alternatives are available?
Calcium Acetate is a drug 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, Chartwell Molecular, and Padagis Us. and is included in fourteen NDAs.
The generic ingredient in CALCIUM ACETATE is calcium acetate. There are two hundred and eighty-two drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Calcium Acetate
A generic version of CALCIUM ACETATE was approved as calcium acetate by HIKMA on February 26th, 2008.
Summary for CALCIUM ACETATE
| US Patents: | 0 |
| Applicants: | 12 |
| NDAs: | 14 |
| Finished Product Suppliers / Packagers: | 19 |
| Raw Ingredient (Bulk) Api Vendors: | 60 |
| Clinical Trials: | 40 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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
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 Hospital | 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms | CALCIUM ACETATE | calcium acetate | CAPSULE;ORAL | 201658-001 | Oct 6, 2014 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin Ltd | CALCIUM ACETATE | calcium acetate | CAPSULE;ORAL | 202127-001 | Jul 9, 2015 | AB | RX | No | No | ⤷ 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 | |||
| Heritage Pharms Inc | CALCIUM ACETATE | calcium acetate | TABLET;ORAL | 202885-001 | Jan 22, 2015 | 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 |
