ERLOTINIB HYDROCHLORIDE Drug Patent Profile
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When do Erlotinib Hydrochloride patents expire, and what generic alternatives are available?
Erlotinib Hydrochloride is a drug 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, and Zydus Pharms. and is included in thirteen NDAs.
The generic ingredient in ERLOTINIB HYDROCHLORIDE is erlotinib hydrochloride. There are twenty-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Erlotinib Hydrochloride
A generic version of ERLOTINIB HYDROCHLORIDE was approved as erlotinib hydrochloride by RISING on June 11th, 2014.
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Questions you can ask:
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Summary for ERLOTINIB HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 13 |
| Finished Product Suppliers / Packagers: | 12 |
| 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 |
| 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 | |||
| Shilpa | ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 211960-002 | Nov 5, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa Inc | ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 091059-001 | Nov 9, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Shilpa | ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 211960-003 | Nov 5, 2019 | AB | RX | 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 |
