ANNOVERA Drug Patent Profile
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When do Annovera patents expire, and what generic alternatives are available?
Annovera is a drug marketed by Mayne Pharma and is included in one NDA. There are eight patents protecting this drug.
This drug has fourteen patent family members in fourteen countries.
The generic ingredient in ANNOVERA is ethinyl estradiol; segesterone acetate. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; segesterone acetate profile page.
DrugPatentWatch® Generic Entry Outlook for Annovera
Annovera was eligible for patent challenges on August 10, 2022.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 21, 2039. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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- What is the 5 year forecast for ANNOVERA?
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Summary for ANNOVERA
| International Patents: | 14 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 2 |
| Drug Prices: | Drug price information for ANNOVERA |
| What excipients (inactive ingredients) are in ANNOVERA? | ANNOVERA excipients list |
| DailyMed Link: | ANNOVERA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ANNOVERA
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ANNOVERA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| TherapeuticsMD | Phase 1 |
Pharmacology for ANNOVERA
| Drug Class | Estrogen Progestin |
| Mechanism of Action | Estrogen Receptor Agonists |
US Patents and Regulatory Information for ANNOVERA
ANNOVERA is protected by eleven US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ANNOVERA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ANNOVERA
Method of providing birth control
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF CONTRACEPTION BY INSERTING A VAGINAL SYSTEM FOR UP TO 13 21/7-DAY (IN/OUT) CYCLES, WHEREIN EFFICACY REQUIRES THE SYSTEM CANNOT BE OUT OF THE VAGINA FOR MORE THAN 2 CUMULATIVE HOURS IN ANY SUCH CYCLE WITHOUT USING ALTERNATIVE CONTRACEPTION
Method of providing birth control
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF PREVENTING PREGNANCY BY INSERTING A VAGINAL SYSTEM CONTAINING 103 MG OF SEGESTERONE ACETATE AND 17.4 MG ETHINYL ESTRADIOL INTO A VAGINA FOR UP TO THIRTEEN 21/7-DAY (IN/OUT) CYCLES
Method of providing birth control
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF PREVENTING PREGNANCY BY INSERTING A VAGINAL SYSTEM CONTAINING 103 MG OF SEGESTERONE ACETATE AND 17.4 MG ETHINYL ESTRADIOL INTO A VAGINA FOR UP TO THIRTEEN 21/7-DAY (IN/OUT) CYCLES
Method of providing birth control
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF CONTRACEPTION BY INSERTING A VAGINAL SYSTEM FOR UP TO 13 21/7-DAY (IN/OUT) CYCLES, WHEREIN EFFICACY REQUIRES THE SYSTEM CANNOT BE OUT OF THE VAGINA FOR MORE THAN 2 CUMULATIVE HOURS IN ANY SUCH CYCLE WITHOUT USING ALTERNATIVE CONTRACEPTION
Method of providing birth control
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF CONTRACEPTION BY INSERTING A VAGINAL SYSTEM FOR UP TO 13 21/7-DAY (IN/OUT) CYCLES, WHEREIN EFFICACY REQUIRES THE SYSTEM CANNOT BE OUT OF THE VAGINA FOR MORE THAN 2 CUMULATIVE HOURS IN ANY SUCH CYCLE WITHOUT USING ALTERNATIVE CONTRACEPTION
Method of providing birth control
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF PREVENTING PREGNANCY BY INSERTING A VAGINAL SYSTEM CONTAINING 103 MG OF SEGESTERONE ACETATE AND 17.4 MG ETHINYL ESTRADIOL INTO A VAGINA FOR UP TO THIRTEEN 21/7-DAY (IN/OUT) CYCLES
System for providing birth control
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
System for providing birth control
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
System for providing birth control
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF PREVENTING PREGNANCY BY INSERTING A VAGINAL SYSTEM CONTAINING 103 MG OF SEGESTERONE ACETATE AND 17.4 MG OF ETHINYL ESTRADIOL FOR UP TO 1THIRTEEN 21/7-DAY (IN/OUT) CYCLES
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mayne Pharma | ANNOVERA | ethinyl estradiol; segesterone acetate | RING;VAGINAL | 209627-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mayne Pharma | ANNOVERA | ethinyl estradiol; segesterone acetate | RING;VAGINAL | 209627-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mayne Pharma | ANNOVERA | ethinyl estradiol; segesterone acetate | RING;VAGINAL | 209627-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mayne Pharma | ANNOVERA | ethinyl estradiol; segesterone acetate | RING;VAGINAL | 209627-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mayne Pharma | ANNOVERA | ethinyl estradiol; segesterone acetate | RING;VAGINAL | 209627-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 ANNOVERA
When does loss-of-exclusivity occur for ANNOVERA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 0976
Patent: SISTEMA PARA PROPORCIONAR UN CONTROL DE LA NATALIDAD
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 20294780
Patent: System for providing birth control
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2021025853
Patent: Sistema para fornecimento de controle de natalidade
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 41077
Patent: SYSTEME DE FOURNITURE DE CONTRACEPTION (SYSTEM FOR PROVIDING BIRTH CONTROL)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 21003410
Patent: Sistema para proporcionar control de la natalidad
Estimated Expiration: ⤷ Sign Up
China
Patent: 4364369
Patent: 用于提供节育的系统 (System for providing birth control)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 21017509
Patent: Sistema para proporcionar control de la natalidad
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 86375
Patent: SYSTÈME DE FOURNITURE DE CONTRACEPTION (SYSTEM FOR PROVIDING BIRTH CONTROL)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 9135
Patent: מערכת למתן אמצעי מניעה (System for providing birth control)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 22536836
Patent: 受胎調節を提供するためのシステム
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 22000047
Patent: SISTEMA PARA PROPORCIONAR CONTROL DE LA NATALIDAD. (SYSTEM FOR PROVIDING BIRTH CONTROL.)
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 2110288
Patent: SYSTEM FOR PROVIDING BIRTH CONTROL
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 220027979
Patent: 산아 제한을 제공하기 위한 시스템
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ANNOVERA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 3141077 | SYSTEME DE FOURNITURE DE CONTRACEPTION (SYSTEM FOR PROVIDING BIRTH CONTROL) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2020257544 | ⤷ Sign Up | |
| Japan | 2022536836 | 受胎調節を提供するためのシステム | ⤷ Sign Up |
| Colombia | 2021017509 | Sistema para proporcionar control de la natalidad | ⤷ Sign Up |
| European Patent Office | 3986375 | SYSTÈME DE FOURNITURE DE CONTRACEPTION (SYSTEM FOR PROVIDING BIRTH CONTROL) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ANNOVERA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 1214076 | 49/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
| 1453521 | 300814 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 0771217 | 07C0001 | France | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804 |
| 1453521 | CA 2016 00016 | Denmark | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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