ALOSETRON HYDROCHLORIDE Drug Patent Profile
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When do Alosetron Hydrochloride patents expire, and what generic alternatives are available?
Alosetron Hydrochloride is a drug marketed by Amneal Pharms, Endo Operations, Hibrow Hlthcare, Hikma, Mankind Pharma, and Rising. and is included in six NDAs.
The generic ingredient in ALOSETRON HYDROCHLORIDE 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 Alosetron Hydrochloride
A generic version of ALOSETRON HYDROCHLORIDE was approved as alosetron hydrochloride by AMNEAL PHARMS on December 22nd, 2016.
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Questions you can ask:
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Summary for ALOSETRON HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 108 |
| Clinical Trials: | 5 |
| Patent Applications: | 174 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ALOSETRON HYDROCHLORIDE |
| What excipients (inactive ingredients) are in ALOSETRON HYDROCHLORIDE? | ALOSETRON HYDROCHLORIDE excipients list |
| DailyMed Link: | ALOSETRON HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for ALOSETRON HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GlaxoSmithKline | Phase 4 |
| Hadassah Medical Organization | Phase 1 |
| GlaxoSmithKline | Phase 2 |
Pharmacology for ALOSETRON HYDROCHLORIDE
| Drug Class | Serotonin-3 Receptor Antagonist |
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for ALOSETRON HYDROCHLORIDE
Paragraph IV (Patent) Challenges for ALOSETRON HYDROCHLORIDE
| 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 ALOSETRON HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms | ALOSETRON HYDROCHLORIDE | alosetron hydrochloride | TABLET;ORAL | 206647-001 | Dec 22, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | ALOSETRON HYDROCHLORIDE | alosetron hydrochloride | TABLET;ORAL | 200652-001 | May 4, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Endo Operations | ALOSETRON HYDROCHLORIDE | alosetron hydrochloride | TABLET;ORAL | 206113-002 | Feb 23, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | ALOSETRON HYDROCHLORIDE | alosetron hydrochloride | TABLET;ORAL | 209180-002 | Jan 14, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | ALOSETRON HYDROCHLORIDE | alosetron hydrochloride | TABLET;ORAL | 200652-002 | May 4, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal Pharms | ALOSETRON HYDROCHLORIDE | alosetron hydrochloride | TABLET;ORAL | 206647-002 | Dec 22, 2016 | AB | RX | No | 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 |
