Details for New Drug Application (NDA): 210910
✉ Email this page to a colleague
NDA 210910 describes AEMCOLO, which is a drug marketed by Cosmo Technologies and is included in one NDA. There are four patents protecting this drug. Additional details are available on the AEMCOLO profile page.
The generic ingredient in AEMCOLO is rifamycin sodium. There are eleven drug master file entries for this compound. Additional details are available on the rifamycin sodium profile page.
The generic ingredient in AEMCOLO is rifamycin sodium. There are eleven drug master file entries for this compound. Additional details are available on the rifamycin sodium profile page.
Summary for 210910
| Tradename: | AEMCOLO |
| Applicant: | Cosmo Technologies |
| Ingredient: | rifamycin sodium |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210910
Generic Entry Date for 210910*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW Dosage:
TABLET, DELAYED RELEASE;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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 194MG BASE | ||||
| Approval Date: | Nov 16, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 16, 2028 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Nov 16, 2023 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 8,263,120 | Patent Expiration: | May 3, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 210910
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cosmo Technologies | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | 8,529,945 | ⤷ Try for Free |
| Cosmo Technologies | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | 8,486,446 | ⤷ Try for Free |
| Cosmo Technologies | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | 8,741,948 | ⤷ Try for Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
