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ATOVAQUONE Drug Profile
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When do Atovaquone patents expire, and what generic alternatives are available?
Atovaquone is a drug marketed by Abhai Llc, Amneal Pharms, Apotex, Glenmark Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Paddock Labs Llc, Glenmark Generics, and Mylan. and is included in nine NDAs.
The generic ingredient in ATOVAQUONE 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.
Summary for ATOVAQUONE
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 9 |
| Suppliers / Packagers: | 12 |
| Bulk Api Vendors: | 123 |
| Clinical Trials: | 40 |
| Patent Applications: | 4,377 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ATOVAQUONE |
| DailyMed Link: | ATOVAQUONE at DailyMed |
Recent Clinical Trials for ATOVAQUONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| NHS Research Scotland | Phase 1 |
| National Institute for Health Research, United Kingdom | Phase 1 |
| Oxford University Hospitals NHS Trust | Phase 1 |
Pharmacology for ATOVAQUONE
| Drug Class | Antimalarial Antiprotozoal |
Medical Subject Heading (MeSH) Categories for ATOVAQUONE
Paragraph IV (Patent) Challenges for ATOVAQUONE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MEPRON | SUSPENSION;ORAL | atovaquone | 020500 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abhai Llc | ATOVAQUONE | atovaquone | SUSPENSION;ORAL | 210510-001 | May 31, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Paddock Labs Llc | ATOVAQUONE | atovaquone | SUSPENSION;ORAL | 207833-001 | Apr 28, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Glenmark Pharms | ATOVAQUONE | atovaquone | SUSPENSION;ORAL | 209685-001 | Nov 21, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
