Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210132

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NDA 210132 describes BIJUVA, which is a drug marketed by Therapeuticsmd Inc and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the BIJUVA profile page.

The generic ingredient in BIJUVA is estradiol; progesterone. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol; progesterone profile page.
Summary for 210132
Tradename:BIJUVA
Applicant:Therapeuticsmd Inc
Ingredient:estradiol; progesterone
Patents:12
Generic Entry Opportunity Date for 210132
Generic Entry Date for 210132*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*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.

Pharmacology for NDA: 210132
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 210132
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BIJUVA estradiol; progesterone CAPSULE;ORAL 210132 NDA TherapeuticsMD, Inc. 50261-211 50261-211-05 1 BLISTER PACK in 1 CARTON (50261-211-05) > 5 CAPSULE in 1 BLISTER PACK
BIJUVA estradiol; progesterone CAPSULE;ORAL 210132 NDA TherapeuticsMD, Inc. 50261-211 50261-211-30 1 BLISTER PACK in 1 CARTON (50261-211-30) > 30 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1MG;100MG
Approval Date:Oct 28, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 28, 2021
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Nov 21, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Nov 21, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

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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 verifification 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.