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 Therapeuticsmd Inc and is included in one NDA. There are six patents protecting this drug.
This drug has seven patent family members in seven countries.
The generic ingredient in ANNOVERA is ethinyl estradiol; segesterone acetate. There are twenty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ethinyl estradiol; segesterone acetate profile page.
DrugPatentWatch® Generic Entry Outlook for Annovera
Annovera will be eligible for patent challenges on August 10, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
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
Summary for ANNOVERA
International Patents: | 7 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 2 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ANNOVERA |
What excipients (inactive ingredients) are in ANNOVERA? | ANNOVERA excipients list |
DailyMed Link: | ANNOVERA at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity 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
Sponsor | Phase |
---|---|
TherapeuticsMD | Phase 1 |
Pharmacology for ANNOVERA
Drug Class | Estrogen Progestin |
Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ANNOVERA
US Patents and Regulatory Information for ANNOVERA
ANNOVERA is protected by nine US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ANNOVERA is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
System for providing birth control
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
System for providing birth control
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting ANNOVERA
NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing
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:
Australia
Patent: 20294780
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2021025853
Estimated Expiration: See Plans and Pricing
Canada
Patent: 41077
Estimated Expiration: See Plans and Pricing
China
Patent: 4364369
Estimated Expiration: See Plans and Pricing
Israel
Patent: 9135
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 220027979
Estimated Expiration: See Plans and Pricing
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 |
---|---|---|---|
Brazil | 112021025853 | Sistema para fornecimento de controle de natalidade | See Plans and Pricing |
Israel | 289135 | See Plans and Pricing | |
Australia | 2020294780 | System for providing birth control | See Plans and Pricing |
China | 114364369 | 用于提供节育的系统 | See Plans and Pricing |
South Korea | 20220027979 | 산아 제한을 제공하기 위한 시스템 | See Plans and Pricing |
Canada | 3141077 | SYSTEME DE FOURNITURE DE CONTRACEPTION (SYSTEM FOR PROVIDING BIRTH CONTROL) | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2020257544 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ANNOVERA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0398460 | C300221 | Netherlands | See Plans and Pricing | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
1214076 | SZ 49/2008 | Austria | See Plans and Pricing | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON |
1453521 | 122015000093 | Germany | See Plans and Pricing | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
1453521 | CA 2016 00016 | Denmark | See Plans and Pricing | 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 | See Plans and Pricing | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
0136011 | 2000C/027 | Belgium | See Plans and Pricing | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 |
1380301 | CA 2009 00017 | Denmark | See Plans and Pricing | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |