FULVESTRANT Drug Patent Profile
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Which patents cover Fulvestrant, and what generic alternatives are available?
Fulvestrant is a drug marketed by Accord Hlthcare, Alembic, Amneal, Apotex, Chia Tai Tianqing, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms Inc, Hbt Labs Inc, Jiangsu Hansoh Pharm, Sagent Pharms Inc, Sandoz, Teva Pharms Usa Inc, Xiromed, and Zydus Pharms. and is included in seventeen NDAs. There are three patents protecting this drug.
The generic ingredient in FULVESTRANT 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 Fulvestrant
A generic version of FULVESTRANT was approved as fulvestrant by AMNEAL on March 4th, 2019.
Summary for FULVESTRANT
| US Patents: | 3 |
| Applicants: | 16 |
| NDAs: | 17 |
| Finished Product Suppliers / Packagers: | 19 |
| Raw Ingredient (Bulk) Api Vendors: | 102 |
| Clinical Trials: | 385 |
| Patent Applications: | 2,289 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FULVESTRANT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FULVESTRANT |
| What excipients (inactive ingredients) are in FULVESTRANT? | FULVESTRANT excipients list |
| DailyMed Link: | FULVESTRANT at DailyMed |
Recent Clinical Trials for FULVESTRANT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Miami | Phase 2 |
| Tianjin Medical University Cancer Institute and Hospital | N/A |
| Tianjin Medical University Cancer Institute and Hospital | Phase 2 |
Pharmacology for FULVESTRANT
| Drug Class | Estrogen Receptor Antagonist |
| Mechanism of Action | Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators |
Anatomical Therapeutic Chemical (ATC) Classes for FULVESTRANT
Paragraph IV (Patent) Challenges for FULVESTRANT
| 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 FULVESTRANT
FULVESTRANT is protected by three US patents.
Patents protecting FULVESTRANT
Fulvestrant formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN
Fulvestrant formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN
Fulvestrant formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | FULVESTRANT | fulvestrant | SOLUTION;INTRAMUSCULAR | 211689-001 | Nov 17, 2020 | AO | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Xiromed | FULVESTRANT | fulvestrant | SOLUTION;INTRAMUSCULAR | 213553-001 | Aug 13, 2021 | AO | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Eugia Pharma | FULVESTRANT | fulvestrant | SOLUTION;INTRAMUSCULAR | 208811-001 | Jul 23, 2019 | AO | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for FULVESTRANT
| 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 |
