You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 21, 2024

Details for New Drug Application (NDA): 210910

✉ Email this page to a colleague

« Back to Dashboard

NDA 210910 describes AEMCOLO, which is a drug marketed by Redhill and is included in one NDA. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the rifamycin sodium profile page.
Summary for 210910
Ingredient:rifamycin sodium
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210910
Generic Entry Date for 210910*:
Constraining patent/regulatory exclusivity:

*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.

Pharmacology for NDA: 210910
Suppliers and Packaging for NDA: 210910
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AEMCOLO rifamycin sodium TABLET, DELAYED RELEASE;ORAL 210910 NDA RedHill Biopharma Ltd 57841-1200 57841-1200-1 2 BLISTER PACK in 1 CARTON (57841-1200-1) / 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1200-0)
AEMCOLO rifamycin sodium TABLET, DELAYED RELEASE;ORAL 210910 NDA RedHill Biopharma Ltd 57841-1200 57841-1200-2 6 BLISTER PACK in 1 CARTON (57841-1200-2) / 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1200-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 194MG BASE
Approval Date:Nov 16, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 16, 2028
Regulatory Exclusivity Expiration:Nov 16, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Try a TrialPatent Expiration:May 3, 2025Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.