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 GENERICS on January 12th, 2011.
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: | 1,383 |
Formulation / Manufacturing: | see details |
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 |
---|---|
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
Drug Class | Antimalarial Antiprotozoal |
Mechanism of Action | Dihydrofolate Reductase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for Malarone
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-001 | Jul 14, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-001 | Jul 14, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-001 | Jul 14, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-001 | 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
See the table below for patents covering Malarone around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Bulgaria | 62595 | ⤷ Try a Trial | |
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) | ⤷ Try a Trial |
Japan | H08503938 | ⤷ Try a Trial | |
Mexico | 9202993 | DERIVADOS DE NAFTOQUINONAS. | ⤷ Try a Trial |
Denmark | 172273 | ⤷ Try a Trial | |
Luxembourg | 88579 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Malarone
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 |