MALARONE Drug Patent Profile
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When do Malarone patents expire, and when can generic versions of Malarone launch?
Malarone is a drug marketed by Glaxosmithkline and is included in one NDA.
The generic ingredient in MALARONE 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
A generic version of MALARONE was approved as atovaquone; proguanil hydrochloride by GLENMARK PHARMS LTD on January 12th, 2011.
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Summary for MALARONE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 38 |
| Clinical Trials: | 22 |
| Patent Applications: | 1,314 |
| Drug Prices: | Drug price information for MALARONE |
| What excipients (inactive ingredients) are in MALARONE? | MALARONE excipients list |
| DailyMed Link: | MALARONE at DailyMed |
Recent Clinical Trials for MALARONE
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
| Drug Class | Antimalarial Antiprotozoal |
| Mechanism of Action | Dihydrofolate Reductase Inhibitors |
US Patents and Regulatory Information for MALARONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-001 | Jul 14, 2000 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-001 | Jul 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-001 | Jul 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-001 | Jul 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-001 | Jul 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MALARONE
See the table below for patents covering MALARONE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 0123238 | NAPHTHOQUINONE DERIVATIVES | ⤷ Sign Up |
| Slovakia | 281559 | ⤷ Sign Up | |
| Czech Republic | 9501192 | ⤷ Sign Up | |
| Czech Republic | 289692 | Farmaceutická kombinace 2-/4-(4-chlorfenyl)-cyklohexyl/-3-hydroxy-1,4-naftochinonu a proguanilu a farmaceutický prostředek (Pharmaceutical combination of 2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthoquinone and proguanil and pharmaceutical preparation) | ⤷ Sign Up |
| Hungary | 225918 | COMBINATION OF ATOVAQUONE WITH PROGUANIL FOR THE TREATMENT OF PROTOZOAL INFECTIONS AND P. CARINII | ⤷ Sign Up |
| African Intellectual Property Organization (OAPI) | 10352 | Combination of atovaquone with proguanil for the treatment of protozoal infections | ⤷ Sign Up |
| Germany | 69328307 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MALARONE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 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 |
| >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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