ATOVAQUONE - Generic Drug Details
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What are the generic sources for atovaquone and what is the scope of patent protection?
Atovaquone
is the generic ingredient in five branded drugs marketed by Abhai Llc, Abon Pharms Llc, Amneal Pharms, Apotex, Bionpharma, Chartwell Rx, Glenmark Speclt, Hetero Labs Ltd Iii, Lupin Ltd, Glaxosmithkline Llc, Glenmark Pharms Ltd, Mylan, and Glaxosmithkline, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.There are sixteen drug master file entries for atovaquone. Nineteen suppliers are listed for this compound.
Summary for ATOVAQUONE
| US Patents: | 0 |
| Tradenames: | 5 |
| Applicants: | 13 |
| NDAs: | 14 |
| Drug Master File Entries: | 16 |
| Finished Product Suppliers / Packagers: | 19 |
| Raw Ingredient (Bulk) Api Vendors: | 166 |
| Clinical Trials: | 42 |
| Patent Applications: | 6,930 |
| Drug Prices: | Drug price trends for ATOVAQUONE |
| What excipients (inactive ingredients) are in ATOVAQUONE? | ATOVAQUONE excipients list |
| DailyMed Link: | ATOVAQUONE at DailyMed |
Recent Clinical Trials for ATOVAQUONE
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
| Drug Class | Antimalarial Antiprotozoal |
Medical Subject Heading (MeSH) Categories for ATOVAQUONE
Anatomical Therapeutic Chemical (ATC) Classes for ATOVAQUONE
Paragraph IV (Patent) Challenges for ATOVAQUONE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MEPRON | Oral Suspension | atovaquone | 750 mg/5 mL | 020500 | 1 | 2009-10-20 |
US Patents and Regulatory Information for ATOVAQUONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | MEPRON | atovaquone | TABLET;ORAL | 020259-001 | Nov 25, 1992 | DISCN | Yes | 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 | |||
| Apotex | ATOVAQUONE | atovaquone | SUSPENSION;ORAL | 209750-001 | Oct 11, 2017 | 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 | |||
| 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 | |||
| Lupin Ltd | ATOVAQUONE | atovaquone | SUSPENSION;ORAL | 209105-001 | Sep 11, 2018 | AB | RX | No | No | ⤷ 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 | |||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | MEPRON | atovaquone | SUSPENSION;ORAL | 020500-001 | Feb 8, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | MEPRON | atovaquone | TABLET;ORAL | 020259-001 | Nov 25, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | MEPRON | atovaquone | TABLET;ORAL | 020259-001 | Nov 25, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | MEPRON | atovaquone | SUSPENSION;ORAL | 020500-001 | Feb 8, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | MEPRON | atovaquone | SUSPENSION;ORAL | 020500-001 | Feb 8, 1995 | ⤷ 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.
ISSN: 2162-2639
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