IMVEXXY Drug Patent Profile
✉ Email this page to a colleague
When do Imvexxy patents expire, 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-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-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: | 162 |
| US Patents: | 20 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 109 |
| Clinical Trials: | 2 |
| Patent Applications: | 4,210 |
| 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 |
|---|---|---|---|
| Australia | 2013211876 | Transdermal hormone replacement therapies | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2017100378 | ⤷ Try a Trial | |
| Hungary | E055275 | ⤷ Try a Trial | |
| Brazil | 112014031910 | formulações e terapias naturais de combinação para reposição hormonal | ⤷ Try a Trial |
| Australia | 2021240253 | Natural Combination Hormone Replacement Formulations And Therapies | ⤷ Try a Trial |
| Spain | 2885523 | ⤷ 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 |
|---|---|---|---|---|
| 0398460 | C300221 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
| 1453521 | C 2015 029 | Romania | ⤷ Try a Trial | 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 |
| 2782584 | 2021C/558 | Belgium | ⤷ Try a Trial | PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406 |
| 0770388 | PA2009004,C0770388 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103 |
| 0771217 | 07C0001 | France | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804 |
| 0398460 | 04C0022 | France | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211 |
| >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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - HIPAA-ready chat for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
