MALARONE PEDIATRIC Drug Patent Profile
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Which patents cover Malarone Pediatric, and what generic alternatives are available?
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 PHARMS LTD 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 |
---|---|
The 108 Military Central Hospital | Phase 4 |
Australian Defence Force Malaria and Infectious Disease Institute (ADF MIDI) | Phase 4 |
Naval Medical Research Unit TWO (NAMRU-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 |
---|---|---|---|
Hong Kong | 1004468 | ⤷ Try a Trial | |
Australia | 574353 | ⤷ Try a Trial | |
Spain | 2145114 | ⤷ Try a Trial | |
Cyprus | 1549 | NAPHTHOQUINONE DERIVATIVES | ⤷ 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 |