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Last Updated: September 19, 2020

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annovera Drug Profile

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When do Annovera patents expire, and when can generic versions of Annovera launch?

Annovera is a drug marketed by Therapeuticsmd Inc and is included in one NDA. There is one patent protecting this drug.

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.

US ANDA Litigation and 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 August 10, 2023. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for annovera
Drug Prices for annovera

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Generic Entry Opportunity Date for annovera
Generic Entry Date for annovera*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
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

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Pharmacology for annovera
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

US Patents and Regulatory Information for annovera

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Therapeuticsmd Inc ANNOVERA ethinyl estradiol; segesterone acetate RING;VAGINAL 209627-001 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Therapeuticsmd Inc ANNOVERA ethinyl estradiol; segesterone acetate RING;VAGINAL 209627-001 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Boehringer Ingelheim
Baxter
AstraZeneca
Merck
Colorcon

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.