PHOSLYRA Drug Patent Profile
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When do Phoslyra patents expire, and what generic alternatives are available?
Phoslyra is a drug marketed by Fresenius Medcl and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-three patent family members in sixteen countries.
The generic ingredient in PHOSLYRA 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 Phoslyra
A generic version of PHOSLYRA was approved as calcium acetate by HIKMA on February 26th, 2008.
Summary for PHOSLYRA
| International Patents: | 23 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 60 |
| Clinical Trials: | 2 |
| Patent Applications: | 1,706 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PHOSLYRA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PHOSLYRA |
| What excipients (inactive ingredients) are in PHOSLYRA? | PHOSLYRA excipients list |
| DailyMed Link: | PHOSLYRA at DailyMed |
Recent Clinical Trials for PHOSLYRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Vifor Fresenius Medical Care Renal Pharma | Phase 3 |
| Fresenius Medical Care North America | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for PHOSLYRA
Paragraph IV (Patent) Challenges for PHOSLYRA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PHOSLYRA | Oral Solution | calcium acetate | 667 mg/5 mL | 022581 | 2 | 2013-12-05 |
US Patents and Regulatory Information for PHOSLYRA
PHOSLYRA is protected by three US patents.
Patents protecting PHOSLYRA
Liquid compositions of calcium acetate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS
Liquid compositions of calcium acetate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS
Liquid compositions of calcium acetate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fresenius Medcl | PHOSLYRA | calcium acetate | SOLUTION;ORAL | 022581-001 | Apr 18, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fresenius Medcl | PHOSLYRA | calcium acetate | SOLUTION;ORAL | 022581-001 | Apr 18, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
International Patents for PHOSLYRA
See the table below for patents covering PHOSLYRA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| 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 |
| Austria | E547099 | ⤷ Try a Trial | |
| Japan | 5335674 | ⤷ Try a Trial | |
| European Patent Office | 2484352 | Compositions liquides d'acétate de calcium (Liquid compositions of calcium acetate) | ⤷ Try a Trial |
| Poland | 2048948 | ⤷ Try a Trial | |
| Hong Kong | 1202815 | 醋酸鈣的液體組合物 (LIQUID COMPOSITIONS OF CALCIUM ACETATE) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PHOSLYRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0247633 | 62/1997 | Austria | ⤷ Try a Trial | PRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107 |
| 2365988 | 122018000012 | Germany | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM UND SALZE DAVON IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719 |
| 2957286 | 2018/046 | Ireland | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719 |
| 2365988 | 2018C/006 | Belgium | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM OF EERDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721 |
| 2957286 | 300962 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721 |
| 2957286 | CR 2018 00043 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179/001-009 20170721 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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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