Anastrozole - Generic Drug Details
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What are the generic 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
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 1MG | 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 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Norvium Bioscience | ANASTROZOLE | anastrozole | TABLET;ORAL | 091051-001 | Jun 28, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Natco Pharma Ltd | ANASTROZOLE | anastrozole | TABLET;ORAL | 079220-001 | Jun 28, 2010 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sun Pharm Inds Ltd | ANASTROZOLE | anastrozole | TABLET;ORAL | 091177-001 | Jul 15, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Synthon Pharms | ANASTROZOLE | anastrozole | TABLET;ORAL | 078322-001 | Jun 28, 2010 | 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 |
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 |
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