ARIMIDEX Drug Patent Profile
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Which patents cover Arimidex, and what generic alternatives are available?
Arimidex is a drug marketed by Ani Pharms and is included in one NDA.
The generic ingredient in ARIMIDEX is anastrozole. There are twenty-four drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the anastrozole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Arimidex
A generic version of ARIMIDEX was approved as anastrozole by ACCORD HLTHCARE on June 28th, 2010.
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Summary for ARIMIDEX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 119 |
| Clinical Trials: | 151 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ARIMIDEX |
| What excipients (inactive ingredients) are in ARIMIDEX? | ARIMIDEX excipients list |
| DailyMed Link: | ARIMIDEX at DailyMed |
Recent Clinical Trials for ARIMIDEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GOG Foundation | Phase 3 |
| European Network of Gynaecological Oncological Trial Groups (ENGOT) | Phase 3 |
| Verastem, Inc. | Phase 3 |
Pharmacology for ARIMIDEX
| Drug Class | Aromatase Inhibitor |
| Mechanism of Action | Aromatase Inhibitors |
US Patents and Regulatory Information for ARIMIDEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | ARIMIDEX | anastrozole | TABLET;ORAL | 020541-001 | Dec 27, 1995 | AB | RX | Yes | Yes | ⤷ 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 ARIMIDEX
| 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 |
International Patents for ARIMIDEX
See the table below for patents covering ARIMIDEX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 1691188 | ⤷ Sign Up | |
| New Zealand | 225037 | SUBSTITUTED HETEROCYCLIC DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS | ⤷ Sign Up |
| Hungary | 211142 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ARIMIDEX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0296749 | 09C0055 | France | ⤷ Sign Up | PRODUCT NAME: ANASTROZOLE, EVENTUELLEMENT SOUS LA FORME D’UN SEL D’ADDITION ACCEPTABLE EN MEDECINE PHARMACEUTIQUE; REGISTRATION NO/DATE IN FRANCE: NL 21126 DU 19961227; REGISTRATION NO/DATE AT EEC: 12619/0106 DU 19950811 |
| 0296749 | C970012 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ANASSTROZOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT; NAT. REGISTRATION NO/DATE: RVG 19123 19960905; FIRST REGISTRATION: GB 12619/0106 19950811 |
| 0296749 | 97C0023 | France | ⤷ Sign Up | PRODUCT NAME: ANASTROZOLE, EVENTUELLEMENT SOUS LA FORME D UN SEL D ADDITION ACCEPTABLE EN MEDECINE PHARMACEUTIQUE; NAT REG. NO/DATE: NL 21126 19961227; FIRST REG.: 12619/0106 19950811 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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