FASLODEX Drug Patent Profile
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When do Faslodex patents expire, and what generic alternatives are available?
Faslodex is a drug marketed by Astrazeneca and is included in one NDA.
The generic ingredient in FASLODEX is fulvestrant. There are twelve drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Faslodex
A generic version of FASLODEX was approved as fulvestrant by AMNEAL on March 4th, 2019.
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Summary for FASLODEX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 102 |
| Clinical Trials: | 165 |
| Patent Applications: | 3,851 |
| Drug Prices: | Drug price information for FASLODEX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FASLODEX |
| What excipients (inactive ingredients) are in FASLODEX? | FASLODEX excipients list |
| DailyMed Link: | FASLODEX at DailyMed |
Recent Clinical Trials for FASLODEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Washington | Phase 2 |
| Breast Cancer Research Foundation | Phase 2 |
| Carrick Therapeutics Limited | Phase 2 |
Pharmacology for FASLODEX
| Drug Class | Estrogen Receptor Antagonist |
| Mechanism of Action | Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators |
Paragraph IV (Patent) Challenges for FASLODEX
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FASLODEX | Injection | fulvestrant | 50 mg/mL, 2.5 mL and 5 mL syringe | 021344 | 1 | 2009-10-01 |
US Patents and Regulatory Information for FASLODEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-002 | Apr 25, 2002 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | AO | 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 FASLODEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for FASLODEX
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Mylan Pharmaceuticals Limited | Fulvestrant Mylan | fulvestrant | EMEA/H/C/004649 Fulvestrant is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:not previously treated with endocrine therapy, orwith disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on antiestrogen therapy. |
Authorised | yes | no | no | 2018-01-08 | |
| AstraZeneca AB | Faslodex | fulvestrant | EMEA/H/C/000540 Faslodex is indicated, , , as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:, , not previously treated with endocrine therapy, or, with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy., , , in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy., , , In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist., |
Authorised | no | no | no | 2004-03-09 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for FASLODEX
See the table below for patents covering FASLODEX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | S6097995 | STEROID DERIVATIVE, MANUFACTURE ANTIESTROGENIC MEDICINE COMPOSITION | ⤷ Sign Up |
| Japan | 2004107353 | FULVESTRANT FORMULATION | ⤷ Sign Up |
| Poland | 356030 | ⤷ Sign Up | |
| France | 2803516 | FORMULATION INJECTABLE DE FULVESTRANT | ⤷ Sign Up |
| Japan | H0216759 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FASLODEX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0138504 | 91068 | Luxembourg | ⤷ Sign Up | 91068, EXPIRES: 20091002 |
| 0138504 | 300158 | Netherlands | ⤷ Sign Up | 300158, 20041002, EXPIRES: 20091001 |
| 0138504 | 2004C/004 | Belgium | ⤷ Sign Up | PRODUCT NAME: FULVESTRANT; REGISTRATION NO/DATE: EU/1/03/269/001 20040311 |
| 0138504 | SPC/GB04/009 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: FULVESTRANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/03/269/001 20040310 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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.
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