NIFURTIMOX - Generic Drug Details
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What are the generic drug sources for nifurtimox and what is the scope of patent protection?
Nifurtimox
is the generic ingredient in one branded drug marketed by Bayer Healthcare and is included in one NDA. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for NIFURTIMOX
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 39 |
| Clinical Trials: | 22 |
| Patent Applications: | 10 |
| What excipients (inactive ingredients) are in NIFURTIMOX? | NIFURTIMOX excipients list |
| DailyMed Link: | NIFURTIMOX at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NIFURTIMOX
Generic Entry Date for NIFURTIMOX*:
Constraining patent/regulatory exclusivity:
INDICATED IN PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE AND WEIGHING AT LEAST 2.5 KG) FOR THE TREATMENT OF CHAGAS DISEASE (AMERICAN TRYPANOSOMIASIS) CAUSED BY TRYPANOSOMA CRUZI Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for NIFURTIMOX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Juan D. Maya | Phase 2 |
| Laboratorio Elea Phoenix S.A. | Phase 3 |
| Drugs for Neglected Diseases initiative | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for NIFURTIMOX
US Patents and Regulatory Information for NIFURTIMOX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Healthcare | LAMPIT | nifurtimox | TABLET;ORAL | 213464-001 | Aug 6, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Healthcare | LAMPIT | nifurtimox | TABLET;ORAL | 213464-002 | Aug 6, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Healthcare | LAMPIT | nifurtimox | TABLET;ORAL | 213464-002 | Aug 6, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Healthcare | LAMPIT | nifurtimox | TABLET;ORAL | 213464-001 | Aug 6, 2020 | 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 |
