Erlotinib hydrochloride - Generic Drug Details
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What are the generic drug sources for erlotinib hydrochloride and what is the scope of patent protection?
Erlotinib hydrochloride
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alembic, Apotex, Chartwell Rx, Eugia Pharma, Hetero Labs Ltd V, MSN, Natco Pharma Ltd, Rising, Shilpa, Sun Pharm, Teva Pharms Usa Inc, Zydus Pharms, and Osi Pharms, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-three drug master file entries for erlotinib hydrochloride. Thirteen suppliers are listed for this compound.
Summary for erlotinib hydrochloride
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 14 |
NDAs: | 14 |
Drug Master File Entries: | 23 |
Finished Product Suppliers / Packagers: | 13 |
Raw Ingredient (Bulk) Api Vendors: | 126 |
Clinical Trials: | 833 |
Patent Applications: | 19 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for erlotinib hydrochloride |
What excipients (inactive ingredients) are in erlotinib hydrochloride? | erlotinib hydrochloride excipients list |
DailyMed Link: | erlotinib hydrochloride at DailyMed |
Recent Clinical Trials for erlotinib hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
State University of New York - Downstate Medical Center | Phase 1/Phase 2 |
China Medical University Hospital | Phase 1/Phase 2 |
MedSIR | Phase 2 |
Pharmacology for erlotinib hydrochloride
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Medical Subject Heading (MeSH) Categories for erlotinib hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for erlotinib hydrochloride
Paragraph IV (Patent) Challenges for ERLOTINIB HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TARCEVA | Tablets | erlotinib hydrochloride | 25 mg | 021743 | 1 | 2008-11-18 |
US Patents and Regulatory Information for erlotinib hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm | ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 210300-003 | Nov 5, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Natco Pharma Ltd | ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 208488-001 | Nov 5, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Eugia Pharma | ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 216342-003 | Jun 22, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Accord Hlthcare | ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 211083-001 | Jul 2, 2020 | 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 erlotinib hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-003 | Nov 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-001 | Nov 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-002 | Nov 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-003 | Nov 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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