EXEMESTANE Drug Patent Profile
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When do Exemestane patents expire, and what generic alternatives are available?
Exemestane is a drug marketed by Alvogen, Amneal Pharms, Breckenridge, Cipla, Dr Reddys Labs Sa, Eugia Pharma, Hikma, Qilu, Rising, Upsher Smith Labs, and Zydus Pharms. and is included in eleven NDAs.
The generic ingredient in EXEMESTANE is exemestane. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the exemestane profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Exemestane
A generic version of EXEMESTANE was approved as exemestane by HIKMA on April 1st, 2011.
Summary for EXEMESTANE
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 100 |
| Clinical Trials: | 246 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EXEMESTANE |
| What excipients (inactive ingredients) are in EXEMESTANE? | EXEMESTANE excipients list |
| DailyMed Link: | EXEMESTANE at DailyMed |
Recent Clinical Trials for EXEMESTANE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Miami | Phase 2 |
| Ottawa Hospital Research Institute | Phase 4 |
| Arvinas Estrogen Receptor, Inc. | Phase 3 |
Pharmacology for EXEMESTANE
| Drug Class | Aromatase Inhibitor |
| Mechanism of Action | Aromatase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for EXEMESTANE
US Patents and Regulatory Information for EXEMESTANE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alvogen | EXEMESTANE | exemestane | TABLET;ORAL | 200898-001 | Jul 28, 2014 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hikma | EXEMESTANE | exemestane | TABLET;ORAL | 077431-001 | Apr 1, 2011 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Cipla | EXEMESTANE | exemestane | TABLET;ORAL | 210323-001 | Apr 27, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Qilu | EXEMESTANE | exemestane | TABLET;ORAL | 213547-001 | Apr 13, 2020 | AB | RX | 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 |
