ANASTROZOLE - Generic Drug Details
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What are the generic drug sources for anastrozole and what is the scope of freedom to operate?
Anastrozole
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Apotex Inc, Beijing Yiling, Chartwell Molecular, Chartwell Rx, Cipla, Eugia Pharma, Fresenius Kabi Usa, Hikma, Impax Labs Inc, Kenton, Natco Pharma Ltd, Norvium Bioscience, Sandoz, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Watson Labs Teva, Zydus Pharms Usa Inc, and Ani Pharms, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-four drug master file entries for anastrozole. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for ANASTROZOLE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 20 |
| NDAs: | 20 |
| Drug Master File Entries: | 24 |
| Finished Product Suppliers / Packagers: | 24 |
| Raw Ingredient (Bulk) Api Vendors: | 119 |
| Clinical Trials: | 316 |
| Patent Applications: | 7,080 |
| Drug Prices: | Drug price trends for ANASTROZOLE |
| Drug Sales Revenues: | Drug sales revenues for ANASTROZOLE |
| What excipients (inactive ingredients) are in ANASTROZOLE? | ANASTROZOLE excipients list |
| DailyMed Link: | ANASTROZOLE at DailyMed |
Recent Clinical Trials for ANASTROZOLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Breast Cancer Research Foundation | Phase 2 |
| University of Wisconsin, Madison | Phase 2 |
| GOG Foundation | Phase 3 |
Generic filers with tentative approvals for ANASTROZOLE
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 ANASTROZOLE
| Drug Class | Aromatase Inhibitor |
| Mechanism of Action | Aromatase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ANASTROZOLE
US Patents and Regulatory Information for ANASTROZOLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Impax Labs Inc | ANASTROZOLE | anastrozole | TABLET;ORAL | 091242-001 | May 31, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | ANASTROZOLE | anastrozole | TABLET;ORAL | 078485-001 | Jun 28, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cipla | ANASTROZOLE | anastrozole | TABLET;ORAL | 091164-001 | Jun 28, 2010 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fresenius Kabi Usa | ANASTROZOLE | anastrozole | TABLET;ORAL | 090088-001 | Jun 28, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex Inc | ANASTROZOLE | anastrozole | TABLET;ORAL | 200654-001 | May 11, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Pharms Usa Inc | ANASTROZOLE | anastrozole | TABLET;ORAL | 078921-001 | Jun 28, 2010 | AB | RX | 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 ANASTROZOLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ani Pharms | ARIMIDEX | anastrozole | TABLET;ORAL | 020541-001 | Dec 27, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Ani Pharms | ARIMIDEX | anastrozole | TABLET;ORAL | 020541-001 | Dec 27, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| >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.
ISSN: 2162-2639
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