MALARONE PEDIATRIC Drug Patent Profile
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Which patents cover Malarone Pediatric, and when can generic versions of Malarone Pediatric launch?
Malarone Pediatric is a drug marketed by Glaxosmithkline and is included in one NDA.
The generic ingredient in MALARONE PEDIATRIC is atovaquone; proguanil hydrochloride. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Malarone Pediatric
A generic version of MALARONE PEDIATRIC was approved as atovaquone; proguanil hydrochloride by GLENMARK GENERICS on January 12th, 2011.
Summary for MALARONE PEDIATRIC
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 3 |
Clinical Trials: | 22 |
Patent Applications: | 1 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for MALARONE PEDIATRIC |
DailyMed Link: | MALARONE PEDIATRIC at DailyMed |
Recent Clinical Trials for MALARONE PEDIATRIC
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Naval Medical Research Unit TWO (NAMRU-2) | Phase 4 |
Naval Medical Research Center | Phase 4 |
Naval Environmental Preventive Medicine Unit TWO (NEPMU-2) | Phase 4 |
Pharmacology for MALARONE PEDIATRIC
Drug Class | Antimalarial Antiprotozoal |
Mechanism of Action | Dihydrofolate Reductase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for MALARONE PEDIATRIC
Paragraph IV (Patent) Challenges for MALARONE PEDIATRIC
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
MALARONE PEDIATRIC | Tablets | atovaquone; proguanil hydrochloride | 62.5 mg/25 mg | 021078 | 1 | 2010-09-14 |
MALARONE PEDIATRIC | Tablets | atovaquone; proguanil hydrochloride | 250 mg/100 mg | 021078 | 1 | 2009-04-03 |
US Patents and Regulatory Information for MALARONE PEDIATRIC
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxosmithkline | MALARONE PEDIATRIC | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-002 | Jul 14, 2000 | AB | RX | Yes | 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 MALARONE PEDIATRIC
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | MALARONE PEDIATRIC | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-002 | Jul 14, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | MALARONE PEDIATRIC | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-002 | Jul 14, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | MALARONE PEDIATRIC | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-002 | Jul 14, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | MALARONE PEDIATRIC | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-002 | Jul 14, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MALARONE PEDIATRIC
See the table below for patents covering MALARONE PEDIATRIC around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 257901 | SYNERGISTIC ANTIMALARIAL MIXTURE OF ATOVAGUONE AND PROGUANIL; MEDICAMENTS | ⤷ Try a Trial |
Spain | 2145114 | ⤷ Try a Trial | |
Romania | 119280 | ASOCIERE FARMACEUTICĂ, COMPOZIŢIE FARMACEUTICĂ ŞI UTILIZAREA ASOCIERII FARMACEUTICE PENTRU TRATAMENTUL ŞI/SAU PROFILAXIA UNEI INFECŢII CAUZATE DE PROTOZOARE PARAZITE SAU A UNEI INFECŢII CAUZATE DE PNEUMOCYSTIS CARINII (PHARMACEUTICAL ASSOCIATION, PHARMACEUTICAL COMPOSITION AND THE USE OF PHARMACEUTICAL ASSOCIATION FOR THE TREATMENT AND CAUSED BY PARASITIC PROTOZOA OR PROPHILAXIS OF AN INFECTION INFECTIONS OR AN INFECTION CAUSED BY PNEUMOCYSTIS CARINII) | ⤷ Try a Trial |
African Regional IP Organization (ARIPO) | 517 | Combination of atovaquone and proguanil and its use in treatment of protozoal infections. | ⤷ Try a Trial |
Taiwan | 253835 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MALARONE PEDIATRIC
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0123238 | SPC/GB95/004 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ATOVAQUONE OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: LU 0458/94/08/0741 19940803; UK 0003/0337 19940823 |
0123238 | 95C0009 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ATOVAQUONUM; NATIONAL REGISTRTION NO/DATE: 251 IS 151 F 3 19950710; FIRST REGISTRATION: LU 0458/94/08/0741 19940803 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |