You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 23, 2024

~ Buy the ANNOVERA (ethinyl estradiol; segesterone acetate) Drug Profile, 2024 PDF Report in the Report Store ~

annovera Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

< Available with Subscription >

  Sign Up

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for annovera?
  • What are the global sales for annovera?
  • What is Average Wholesale Price for annovera?
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
Drug patent expirations by year for annovera
Drug Prices for annovera

See drug prices for annovera

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for annovera
Generic Entry Date for annovera*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
RING;VAGINAL

*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

SponsorPhase
TherapeuticsMDPhase 1

See all annovera clinical trials

Pharmacology for annovera
Drug ClassEstrogen
Progestin
Mechanism of ActionEstrogen 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
>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
Colombia 2021017509 Sistema para proporcionar control de la natalidad ⤷  Sign Up
Japan 2022536836 受胎調節を提供するためのシステム ⤷  Sign Up
South Korea 20220027979 산아 제한을 제공하기 위한 시스템 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for annovera

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0771217 07C0001 France ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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
1453521 39/2015 Austria ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
>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.