BONJESTA Drug Patent Profile

When do Bonjesta patents expire, and what generic alternatives are available?

Bonjesta is a drug marketed by Duchesnay and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has sixty patent family members in thirty countries.

The generic ingredient in BONJESTA is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bonjesta

A generic version of BONJESTA was approved as doxylamine succinate; pyridoxine hydrochloride by ACTAVIS LABS FL INC on August 19^th, 2016.

Summary for BONJESTA

International Patents:	60
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BONJESTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BONJESTA
What excipients (inactive ingredients) are in BONJESTA?	BONJESTA excipients list
DailyMed Link:	BONJESTA at DailyMed

See drug prices for BONJESTA

Recent Clinical Trials for BONJESTA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Health Decisions	Phase 3
Duchesnay Inc.	Phase 3

See all BONJESTA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BONJESTA

R06AA	Aminoalkyl ethers
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

Paragraph IV (Patent) Challenges for BONJESTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BONJESTA	Extended-release Tablets	doxylamine succinate; pyridoxine hydrochloride	20 mg/20 mg	209661	1	2018-08-28

US Patents and Regulatory Information for BONJESTA

BONJESTA is protected by four US patents.

Patents protecting BONJESTA

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	AB	RX	Yes	Yes			Y
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016	AB	RX	Yes	Yes			Y
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016	AB	RX	Yes	Yes			Y
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016	AB	RX	Yes	Yes			Y

Expired US Patents for BONJESTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016

International Patents for BONJESTA

When does loss-of-exclusivity occur for BONJESTA?

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

Argentina

Australia

Canada

Chile

China

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Poland

Portugal

Singapore

South Korea

Spain

Taiwan

Uruguay

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 BONJESTA around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2809713
France	2841783	FORME POSOLOGIQUE PHARMACEUTIQUE PORTANT UNE SIGNALISATION INDIQUANT UNE PARFAITE INNOCUITE EN CAS DE GROSSESSE
Eurasian Patent Organization	032671	ТВЕРДАЯ ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ ПЕРОРАЛЬНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩАЯ ДОКСИЛАМИН И ПИРИДОКСИН И/ИЛИ ИХ СОЛИ (SOLID ORAL DOSAGE FORM COMPRISING DOXYLAMINE AND PYRIDOXINE AND/OR SALTS THEREOF)
Japan	6272561