Alosetron hydrochloride - Generic Drug Details
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What are the generic drug sources for alosetron hydrochloride and what is the scope of freedom to operate?
Alosetron hydrochloride
is the generic ingredient in two branded drugs marketed by Amneal Pharms, Endo Operations, Hibrow Hlthcare, Hikma, Mankind Pharma, Rising, and Sebela Ireland Ltd, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for alosetron hydrochloride. Seven suppliers are listed for this compound.
Summary for alosetron hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 7 |
| NDAs: | 7 |
| Drug Master File Entries: | 3 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 108 |
| Clinical Trials: | 5 |
| Patent Applications: | 281 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rising | ALOSETRON HYDROCHLORIDE | alosetron hydrochloride | TABLET;ORAL | 209180-001 | Jan 14, 2019 | AB | RX | 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 | ||||
| Sebela Ireland Ltd | LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107-002 | Dec 23, 2003 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mankind Pharma | ALOSETRON HYDROCHLORIDE | alosetron hydrochloride | TABLET;ORAL | 213614-001 | Sep 9, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hibrow Hlthcare | ALOSETRON HYDROCHLORIDE | alosetron hydrochloride | TABLET;ORAL | 211621-002 | Sep 16, 2019 | 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 |
Expired US Patents for alosetron hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sebela Ireland Ltd | LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107-002 | Dec 23, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Sebela Ireland Ltd | LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107-001 | Feb 9, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Sebela Ireland Ltd | LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107-001 | Feb 9, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Sebela Ireland Ltd | LOTRONEX | alosetron hydrochloride | TABLET;ORAL | 021107-002 | Dec 23, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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.
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