DUCHESNAY Company Profile

What is the competitive landscape for DUCHESNAY, and what generic alternatives to DUCHESNAY drugs are available?

DUCHESNAY has three approved drugs.

There are eleven US patents protecting DUCHESNAY drugs.

There are one hundred and forty patent family members on DUCHESNAY drugs in forty-two countries and sixteen supplementary protection certificates in fourteen countries.

Summary for DUCHESNAY

International Patents:	140
US Patents:	11
Tradenames:	3
Ingredients:	2
NDAs:	3

Drugs and US Patents for DUCHESNAY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes	9,526,703		Y
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	AB	RX	Yes	Yes	9,241,915
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	AB	RX	Yes	Yes	8,236,861
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	AB	RX	Yes	Yes	8,642,079		Y
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	AB	RX	Yes	Yes	8,470,890
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes	9,937,132		Y
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes	9,375,404		Y

Expired US Patents for DUCHESNAY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	6,340,695
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	8,772,353
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	8,470,890
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	9,241,915
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	9,855,224
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	9,566,252
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016	7,560,122

Paragraph IV (Patent) Challenges for DUCHESNAY drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	20 mg/20 mg		2018-08-28
	Delayed-release Tablets	10 mg/10 mg		2013-08-01

International Patents for DUCHESNAY Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	3185856
Poland	1713458
Brazil	112017004190
Hong Kong	1197035
Mexico	2014008594
Czech Republic	200326
Brazil	PI0507897

Supplementary Protection Certificates for DUCHESNAY Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1713458	2015/031	Ireland		PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115
1713458	PA2015023	Lithuania		PRODUCT NAME: OSPEMIFENUM; REGISTRATION NO/DATE: EU/1/14/978/001, 2015 01 15 EU/1/14/978/002 20150115
1713458	SPC/GB15/035	United Kingdom		PRODUCT NAME: OSPEMIFENE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/14/978/001 20150115; UK EU/1/14/978/002 20150115
1713458	122015000048	Germany		PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115
1713458	28/2015	Austria		PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150119
1713458	132016000023047	Italy		PRODUCT NAME: OSPEMIFENE IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE(SENSHIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/978/001-002, 20150115
1713458	CR 2015 00031	Denmark		PRODUCT NAME: OSPEMIFENE OR A GEOMETRIC ISOMER THEREOF, A STEREOISOMER THEREOF, A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AN ESTER THEREOF OR A METABOLITE THEREOF; REG. NO/DATE: EU/1/14/978/001-002 20150115

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Duchesnay