BENZNIDAZOLE Drug Patent Profile
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Which patents cover Benznidazole, and what generic alternatives are available?
Benznidazole is a drug marketed by Chemo Research Sl and is included in one NDA.
The generic ingredient in BENZNIDAZOLE is benznidazole. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the benznidazole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Benznidazole
A generic version of BENZNIDAZOLE was approved as benznidazole by CHEMO RESEARCH SL on August 29th, 2017.
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Summary for BENZNIDAZOLE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 77 |
| Clinical Trials: | 22 |
| Patent Applications: | 1,654 |
| What excipients (inactive ingredients) are in BENZNIDAZOLE? | BENZNIDAZOLE excipients list |
| DailyMed Link: | BENZNIDAZOLE at DailyMed |
Recent Clinical Trials for BENZNIDAZOLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| IC-MedTech Corporation | Phase 1 |
| Juan D. Maya | Phase 2 |
| Laboratorio Elea Phoenix S.A. | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for BENZNIDAZOLE
US Patents and Regulatory Information for BENZNIDAZOLE
BENZNIDAZOLE is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting BENZNIDAZOLE
FOR USE IN CHILDREN AGES 2 TO 12 YEARS OLD WITH CHAGAS DISEASE
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chemo Research Sl | BENZNIDAZOLE | benznidazole | TABLET;ORAL | 209570-001 | Aug 29, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chemo Research Sl | BENZNIDAZOLE | benznidazole | TABLET;ORAL | 209570-002 | Aug 29, 2017 | RX | Yes | Yes | ⤷ 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 |
