ATOVAQUONE; PROGUANIL HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for atovaquone; proguanil hydrochloride and what is the scope of patent protection?
Atovaquone; proguanil hydrochloride
is the generic ingredient in three branded drugs marketed by Glenmark Pharms Ltd, Mylan, and Glaxosmithkline, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.Ten suppliers are listed for this compound.
Summary for ATOVAQUONE; PROGUANIL HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 3 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 10 |
Clinical Trials: | 25 |
DailyMed Link: | ATOVAQUONE; PROGUANIL HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for ATOVAQUONE; PROGUANIL HYDROCHLORIDE
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 ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Drug Class | Antimalarial Antiprotozoal |
Mechanism of Action | Dihydrofolate Reductase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Paragraph IV (Patent) Challenges for ATOVAQUONE; PROGUANIL HYDROCHLORIDE
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 ATOVAQUONE; PROGUANIL HYDROCHLORIDE
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 | |||
Glenmark Pharms Ltd | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 091211-001 | Jan 12, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Mylan | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 202362-001 | May 27, 2014 | AB | RX | No | No | ⤷ 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 ATOVAQUONE; PROGUANIL HYDROCHLORIDE
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 | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-001 | 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 | 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 |
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