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.
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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 |
| Drug Prices: | Drug price information for MALARONE PEDIATRIC |
| DailyMed Link: | MALARONE PEDIATRIC at DailyMed |
Recent Clinical Trials for MALARONE PEDIATRIC
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| 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | MALARONE PEDIATRIC | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-002 | Jul 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | MALARONE PEDIATRIC | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-002 | Jul 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Portugal | 670719 | ⤷ Sign Up | |
| South Africa | 9308832 | ⤷ Sign Up | |
| Norway | 951995 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 |
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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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