ERLOTINIB Drug Patent Profile
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Which patents cover Erlotinib, and what generic alternatives are available?
Erlotinib 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 is erlotinib hydrochloride. There are twenty-five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Erlotinib
A generic version of ERLOTINIB was approved as erlotinib hydrochloride by RISING on June 11th, 2014.
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Summary for ERLOTINIB
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 13 |
| Drug Prices: | Drug price information for ERLOTINIB |
| DailyMed Link: | ERLOTINIB at DailyMed |
US Patents and Regulatory Information for ERLOTINIB
| 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 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Shilpa | ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 211960-002 | Nov 5, 2019 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Teva Pharms Usa Inc | ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 091059-001 | Nov 9, 2020 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Shilpa | ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 211960-003 | Nov 5, 2019 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Accord Hlthcare | ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 211083-001 | Jul 2, 2020 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
