BIJUVA Drug Patent Profile

Which patents cover Bijuva, and when can generic versions of Bijuva launch?

Bijuva is a drug marketed by Therapeuticsmd Inc and is included in one NDA. There are twenty-one patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-eight patent family members in nineteen countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Bijuva

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 21, 2032. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BIJUVA

International Patents:	148
US Patents:	21
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BIJUVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BIJUVA
What excipients (inactive ingredients) are in BIJUVA?	BIJUVA excipients list
DailyMed Link:	BIJUVA at DailyMed

See drug prices for BIJUVA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for BIJUVA

NDA:

210132

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.

Anatomical Therapeutic Chemical (ATC) Classes for BIJUVA

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03DA	Pregnen (4) derivatives
G03D	PROGESTOGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for BIJUVA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BIJUVA	Capsules	estradiol; progesterone	1 mg/100 mg	210132	1	2020-01-06

US Patents and Regulatory Information for BIJUVA

BIJUVA is protected by twenty-one US patents.

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 BIJUVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Therapeuticsmd Inc	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes			Y
Therapeuticsmd Inc	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes			Y
Therapeuticsmd Inc	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes			Y
Therapeuticsmd Inc	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes			Y
Therapeuticsmd Inc	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No			Y
Therapeuticsmd Inc	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes
Therapeuticsmd Inc	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes			Y

International Patents for BIJUVA

When does loss-of-exclusivity occur for BIJUVA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Croatia

European Patent Office

Hungary

Israel

Japan

Lithuania

Mexico

Poland

Portugal

Russian Federation

Serbia

South Africa

South Korea

Spain

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 BIJUVA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2019204655	Natural Combination Hormone Replacement Formulations And Therapies
Israel	248985
Australia	2015237243	Progesterone formulations
Argentina	107022	COMPOSICIONES FARMACÉUTICAS DE ESTRADIOL INSERTADAS POR VÍA VAGINAL Y MÉTODOS
Australia	2017208300	Soluble Estradiol Capsule For Vaginal Insertion
Portugal	2782584
Mexico	2014015898	FORMULACIONES Y TERAPIAS DE REEMPLAZO DE COMBINACION DE HORMONAS NATURALES. (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES.)

Supplementary Protection Certificates for BIJUVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
2782584	LUC00245	Luxembourg		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210701
2782584	122021000080	Germany		PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; NAT. REGISTRATION NO/DATE: 2205034.00.00 20210924; FIRST REGISTRATION: BELGIEN BE582231 20210406
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
0398460	12/2004	Austria		PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211