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. Nine 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for MALARONE?
- What are the global sales for MALARONE?
- What is Average Wholesale Price for MALARONE?
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: | 1,374 |
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 Environmental Preventive Medicine Unit TWO (NEPMU-2) | Phase 4 |
The 108 Military Central Hospital | Phase 4 |
Australian Defence Force Malaria and Infectious Disease Institute (ADF MIDI) | 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 | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Glaxosmithkline | MALARONE PEDIATRIC | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-002 | Jul 14, 2000 | AB | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
>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 | 5,053,432*PED | ⤷ Try for Free |
Glaxosmithkline | MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-001 | Jul 14, 2000 | 6,291,488*PED | ⤷ Try for Free |
Glaxosmithkline | MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-001 | Jul 14, 2000 | 5,998,449*PED | ⤷ Try for Free |
>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 |
---|---|---|---|
Australia | 5532194 | ⤷ Try for Free | |
Germany | 3464132 | ⤷ Try for Free | |
Japan | H08503938 | ⤷ Try for Free | |
>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 | ⤷ Try for Free | 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 | ⤷ Try for Free | 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 |
Market Dynamics and Financial Trajectory for Antimalarial Drugs: A Focus on MALARONE
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