IMVEXXY Drug Patent Profile
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Which patents cover Imvexxy, and what generic alternatives are available?
Imvexxy is a drug marketed by Mayne Pharma and is included in one NDA. There are twenty patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and sixty-one patent family members in twenty-one countries.
The generic ingredient in IMVEXXY is estradiol. There are seventy-five drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the estradiol profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Imvexxy
A generic version of IMVEXXY was approved as estradiol by BARR LABS INC on October 22nd, 1997.
Summary for IMVEXXY
International Patents: | 161 |
US Patents: | 20 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 2 |
Patent Applications: | 4,210 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for IMVEXXY |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for IMVEXXY |
What excipients (inactive ingredients) are in IMVEXXY? | IMVEXXY excipients list |
DailyMed Link: | IMVEXXY at DailyMed |
Recent Clinical Trials for IMVEXXY
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Teva Pharmaceuticals USA | Phase 3 |
University Hospitals Cleveland Medical Center | Phase 4 |
Pharmacology for IMVEXXY
Drug Class | Estrogen |
Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for IMVEXXY
US Patents and Regulatory Information for IMVEXXY
IMVEXXY is protected by thirty-four US patents.
Patents protecting IMVEXXY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA
Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-001 | May 29, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-002 | May 29, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-002 | May 29, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-001 | May 29, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-001 | May 29, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-001 | May 29, 2018 | RX | Yes | 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 |
International Patents for IMVEXXY
See the table below for patents covering IMVEXXY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 112014031910 | formulações e terapias naturais de combinação para reposição hormonal | ⤷ Try a Trial |
South Korea | 20200128214 | 천연 병용 호르몬 대체 제형 및 요법 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) | ⤷ Try a Trial |
Poland | 2861072 | ⤷ Try a Trial | |
Canada | 2942568 | FORMULATIONS DE PROGESTERONE (PROGESTERONE FORMULATIONS) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2013192251 | ⤷ Try a Trial | |
Portugal | 2782584 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IMVEXXY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1453521 | 122015000093 | Germany | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
0398460 | 12/2004 | Austria | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211 |
1453521 | CA 2016 00016 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
1453521 | 39/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
1453521 | 93156 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
0771217 | CA 2006 00038 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |