LETROZOLE - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for letrozole and what is the scope of patent protection?
Letrozole
is the generic ingredient in three branded drugs marketed by Novartis Pharms, Accord Hlthcare, Actavis Totowa, Apotex Inc, Beijing Yiling, Carnegie, Chartwell Rx, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Pharms, Impax Labs, Indicus Pharma, Lannett Co Inc, Mylan, Natco Pharma Ltd, Strides Pharma, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, and Novartis, and is included in twenty-two NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are twenty-four drug master file entries for letrozole. Fifteen suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for LETROZOLE
US Patents: | 8 |
Tradenames: | 3 |
Applicants: | 21 |
NDAs: | 22 |
Drug Master File Entries: | 24 |
Finished Product Suppliers / Packagers: | 15 |
Raw Ingredient (Bulk) Api Vendors: | 135 |
Clinical Trials: | 584 |
Patent Applications: | 7,454 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for LETROZOLE |
Drug Sales Revenues: | Drug sales revenues for LETROZOLE |
What excipients (inactive ingredients) are in LETROZOLE? | LETROZOLE excipients list |
DailyMed Link: | LETROZOLE at DailyMed |
Recent Clinical Trials for LETROZOLE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Universitaire Ziekenhuizen KU Leuven | Phase 2 |
Kom Op Tegen Kanker | Phase 2 |
University of Miami | Phase 2 |
Generic filers with tentative approvals for LETROZOLE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 2.5MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 2.5MG | TABLET; ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 200MG;2.5MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for LETROZOLE
Drug Class | Aromatase Inhibitor |
Mechanism of Action | Aromatase Inhibitors |
US Patents and Regulatory Information for LETROZOLE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Novartis | KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Synthon Pharms | LETROZOLE | letrozole | TABLET;ORAL | 090196-001 | Jun 3, 2011 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 LETROZOLE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis Pharms | FEMARA | letrozole | TABLET;ORAL | 020726-001 | Jul 25, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.