Malathion - Generic Drug Details
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What are the generic drug sources for malathion and what is the scope of freedom to operate?
Malathion
is the generic ingredient in two branded drugs marketed by Mylan Pharms Inc, Suven Pharms, and Taro, and is included in three NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Malathion has nine patent family members in six countries.
There are three drug master file entries for malathion. Two suppliers are listed for this compound.
Summary for malathion
International Patents: | 9 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 3 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Clinical Trials: | 8 |
Patent Applications: | 6,128 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for malathion |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for malathion |
What excipients (inactive ingredients) are in malathion? | malathion excipients list |
DailyMed Link: | malathion at DailyMed |
Recent Clinical Trials for malathion
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
London School of Hygiene and Tropical Medicine | Phase 3 |
Taro Pharmaceuticals USA | Phase 1 |
Taro Pharmaceuticals USA | Phase 2/Phase 3 |
Pharmacology for malathion
Drug Class | Cholinesterase Inhibitor |
Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for malathion
Anatomical Therapeutic Chemical (ATC) Classes for malathion
US Patents and Regulatory Information for malathion
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Suven Pharms | MALATHION | malathion | LOTION;TOPICAL | 091559-001 | May 23, 2012 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Taro | OVIDE | malathion | LOTION;TOPICAL | 018613-001 | Aug 2, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Mylan Pharms Inc | MALATHION | malathion | LOTION;TOPICAL | 078743-001 | Mar 6, 2009 | DISCN | 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 |
International Patents for malathion
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 103087095 | Process for preparing malathion for pharmaceutical use, and combination thereof | ⤷ Sign Up |
Canada | 2612578 | PROCEDE DE PREPARATION DE MALATHION DESTINE A UN USAGE PHARMACEUTIQUE (PROCESS FOR PREPARING MALATHION FOR PHARMACEUTICAL USE) | ⤷ Sign Up |
Japan | 5474347 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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