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 |
|---|---|
| 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 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glenmark Pharms Ltd | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 091211-002 | Apr 6, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glaxosmithkline | MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-001 | Jul 14, 2000 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 202362-002 | May 27, 2014 | 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 | |||
| 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 | |||
| >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 | 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 |
| 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 |
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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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