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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Questions you can ask:
- What is the 5 year forecast for FASLODEX?
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- What is Average Wholesale Price for FASLODEX?
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: | 3,240 |
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 | 021344-001 | Apr 25, 2002 | AO | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-002 | Apr 25, 2002 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
>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 | 4,659,516 | ⤷ Try for Free |
Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | 8,329,680*PED | ⤷ Try for Free |
Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | 6,774,122*PED | ⤷ Try for Free |
Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | 8,466,139*PED | ⤷ Try for Free |
Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | 7,456,160*PED | ⤷ Try for Free |
>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 |
---|---|---|---|---|---|---|---|---|---|
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 | |
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 | |
>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 |
---|---|---|---|
Czech Republic | 304689 | Farmaceutický přípravek obsahující fulvestrant a jeho použití pro výrobu léčiva (Pharmaceutical preparation containing fulvestrant and its use for the preparation of a medicament) | ⤷ Try for Free |
Egypt | 24074 | Formulation | ⤷ Try for Free |
Germany | 60114145 | ⤷ Try for Free | |
Mexico | PA02006698 | FORMULACION DE FULVESTRANT. (FULVESTRANT FORMULATION.) | ⤷ Try for Free |
Taiwan | I259086 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FASLODEX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0138504 | 2004C/004 | Belgium | ⤷ Try for Free | PRODUCT NAME: FULVESTRANT; REGISTRATION NO/DATE: EU/1/03/269/001 20040311 |
0138504 | 300158 | Netherlands | ⤷ Try for Free | 300158, 20041002, EXPIRES: 20091001 |
0138504 | 91068 | Luxembourg | ⤷ Try for Free | 91068, EXPIRES: 20091002 |
0138504 | SPC/GB04/009 | United Kingdom | ⤷ Try for Free | 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 |
Market Dynamics and Financial Trajectory for Faslodex
More… ↓