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Duchesnay Company Profile

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

DUCHESNAY has three approved drugs.

There are fourteen US patents protecting DUCHESNAY drugs.

There are one hundred and seventy-seven patent family members on DUCHESNAY drugs in fifty-three countries and twelve supplementary protection certificates in ten countries.

Summary for Duchesnay

International Patents:	177
US Patents:	14
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	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	AB	RX	Yes	Yes	7,560,122		Y
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes	9,375,404		Y
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		RX	Yes	Yes	6,245,819
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013		RX	Yes	Yes	8,236,861
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes	7,560,122		Y
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes	9,937,132		Y

Paragraph IV (Patent) Challenges for DUCHESNAY drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Delayed-release Tablets	10 mg/10 mg		2013-08-01

Non-Orange Book US Patents for Duchesnay

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,984,665	Methods for the inhibition of atrophy or for treatment or prevention of atrophy-related symptoms in women

International Patents for Duchesnay Drugs

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013123595
South Korea	20030023612
Estonia	05344
Egypt	24483
Portugal	1718288
Eurasian Patent Organization	201790477
Poland	204507

Supplementary Protection Certificates for Duchesnay Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00742	Netherlands		PRODUCT NAME: OSPEMIFEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/14/978 20150115
15/031	Ireland		PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115
2015023	Lithuania		PRODUCT NAME: OSPEMIFENUM; REGISTRATION NO/DATE: EU/1/14/978/001, 2015 01 15 EU/1/14/978/002 20150115
C0041	France		PRODUCT NAME: OSPEMIFENE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/978 20150115
/2015	Austria		PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150119
0150029 00165	Estonia		PRODUCT NAME: OSPEMIFEEN;REG NO/DATE: EU/1/14/978 19.01.2015
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