ALOSETRON HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for alosetron hydrochloride and what is the scope of patent protection?
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 | ||||
>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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