LOTRONEX Drug Patent Profile
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When do Lotronex patents expire, and when can generic versions of Lotronex launch?
Lotronex is a drug marketed by Sebela Ireland Ltd and is included in one NDA.
The generic ingredient in LOTRONEX is alosetron hydrochloride. There are three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the alosetron hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lotronex
A generic version of LOTRONEX was approved as alosetron hydrochloride by AMNEAL PHARMS on December 22nd, 2016.
Summary for LOTRONEX
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 158 |
Patent Applications: | 1,565 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for LOTRONEX |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LOTRONEX |
What excipients (inactive ingredients) are in LOTRONEX? | LOTRONEX excipients list |
DailyMed Link: | LOTRONEX at DailyMed |
Pharmacology for LOTRONEX
Drug Class | Serotonin-3 Receptor Antagonist |
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for LOTRONEX
Paragraph IV (Patent) Challenges for LOTRONEX
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LOTRONEX | Tablets | alosetron hydrochloride | 0.5 mg and 1 mg | 021107 | 1 | 2010-12-02 |
US Patents and Regulatory Information for LOTRONEX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sebela Ireland Ltd | LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107-002 | Dec 23, 2003 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sebela Ireland Ltd | LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107-001 | Feb 9, 2000 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for LOTRONEX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sebela Ireland Ltd | LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107-001 | Feb 9, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Sebela Ireland Ltd | LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107-001 | Feb 9, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Sebela Ireland Ltd | LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107-002 | Dec 23, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Sebela Ireland Ltd | LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107-002 | Dec 23, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LOTRONEX
See the table below for patents covering LOTRONEX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ireland | 61669 | Lactam derivatives | ⤷ Try a Trial |
Japan | 2001518495 | ⤷ Try a Trial | |
Eurasian Patent Organization | 200000299 | ⤷ Try a Trial | |
Japan | H01151578 | LACTAM DERIVATIVE | ⤷ Try a Trial |
European Patent Office | 0306323 | Dérivés de lactames. (Lactam derivatives.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |