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NORMOCARB HF 25 Drug Profile
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When do Normocarb Hf 25 patents expire, and when can generic versions of Normocarb Hf 25 launch?
Normocarb Hf 25 is a drug marketed by Dialysis Sups and is included in one NDA. There is one patent protecting this drug.
This drug has four patent family members in four countries.
The generic ingredient in NORMOCARB HF 25 is magnesium chloride; sodium bicarbonate; sodium chloride. There are one hundred and forty-six drug master file entries for this compound. Additional details are available on the magnesium chloride; sodium bicarbonate; sodium chloride profile page.
US ANDA Litigation and Generic Entry Outlook for Normocarb Hf 25
Indicators of Generic Entry
Summary for NORMOCARB HF 25
| International Patents: | 4 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | NORMOCARB HF 25 at DailyMed |
US Patents and Regulatory Information for NORMOCARB HF 25
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dialysis Sups | NORMOCARB HF 25 | magnesium chloride; sodium bicarbonate; sodium chloride | SOLUTION;INJECTION | 021910-001 | Jul 26, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 NORMOCARB HF 25
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Dialysis Sups | NORMOCARB HF 25 | magnesium chloride; sodium bicarbonate; sodium chloride | SOLUTION;INJECTION | 021910-001 | Jul 26, 2006 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NORMOCARB HF 25
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2365787 | Start Trial |
| Australia | 2620902 | Start Trial |
| European Patent Office | 1347795 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0249693 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NORMOCARB HF 25
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0984957 | CR 2012 00035 | Denmark | Start Trial | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105 |
| 0984957 | 122012000017 | Germany | Start Trial | PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812 |
| 1499331 | SPC/GB13/034 | United Kingdom | Start Trial | PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313 |
| 0124495 | SPC/GB01/006 | United Kingdom | Start Trial | PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727 |
| 0984957 | 2012/048 | Ireland | Start Trial | PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
