IMVEXXY Drug Patent Profile
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Which patents cover Imvexxy, and when can generic versions of Imvexxy launch?
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-two 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-seven 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.
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Questions you can ask:
- What is the 5 year forecast for IMVEXXY?
- What are the global sales for IMVEXXY?
- What is Average Wholesale Price for IMVEXXY?
Summary for IMVEXXY
International Patents: | 162 |
US Patents: | 20 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 2 |
Patent Applications: | 4,111 |
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 |
![IMVEXXY drug patent expirations Drug patent expirations by year for IMVEXXY](/p/graph/s/t/IMVEXXY-patent-expirations.png)
![Drug Prices for IMVEXXY](/p/graph/drug-price/IMVEXXY.png)
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 |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA
Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA
Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-002 | May 29, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-002 | May 29, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-001 | May 29, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-001 | May 29, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-001 | May 29, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-002 | May 29, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 |
---|---|---|---|
Japan | 2016534025 | 膣挿入されるエストラジオール薬学的組成物及び方法 | ⤷ Sign Up |
Brazil | 112019011655 | fórmulas e terapias naturais combinadas para reposição | ⤷ Sign Up |
Argentina | 098160 | COMPOSICIONES FARMACÉUTICAS DE ESTRADIOL INSERTADAS EN LA VAGINA Y PROCEDIMIENTOS | ⤷ Sign Up |
South Korea | 20200013771 | 질 삽입 에스트라디올 약학적 조성물 및 방법 | ⤷ Sign Up |
Russian Federation | 2015100533 | ЕСТЕСТВЕННАЯ КОМБИНАЦИЯ СОСТАВОВ И СПОСОБОВ ГОРМОНОЗАМЕСТИТЕЛЬНОЙ ТЕРАПИИ | ⤷ Sign Up |
Japan | 2019206540 | プロゲステロン製剤 (PROGESTERONE FORMULATIONS) | ⤷ Sign Up |
European Patent Office | 2861072 | FORMULATIONS ET THÉRAPIES DE REMPLACEMENT D'HORMONES DE COMBINAISON NATURELLE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IMVEXXY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0136011 | 2000C/027 | Belgium | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 |
1453521 | C 2015 029 | Romania | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129 |
1453521 | 132016000025143 | Italy | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414 |
1380301 | CA 2009 00017 | Denmark | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 |
0770388 | 09C0018 | France | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103 |
0398460 | C300221 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
0398460 | SPC/GB04/032 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |