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Last Updated: May 26, 2022

BONJESTA Drug Patent Profile


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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.

Drug patent expirations by year for BONJESTA
Drug Prices for BONJESTA

See drug prices for BONJESTA

Recent Clinical Trials for BONJESTA

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

SponsorPhase
Health DecisionsPhase 3
Duchesnay Inc.Phase 3

See all BONJESTA clinical trials

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

Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT

Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT

Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT

Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Duchesnay BONJESTA doxylamine succinate; pyridoxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209661-001 Nov 7, 2016 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Duchesnay BONJESTA doxylamine succinate; pyridoxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209661-001 Nov 7, 2016 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Duchesnay BONJESTA doxylamine succinate; pyridoxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209661-001 Nov 7, 2016 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 0126
Estimated Expiration: See Plans and Pricing

Australia

Patent: 13224598
Estimated Expiration: See Plans and Pricing

Canada

Patent: 48798
Estimated Expiration: See Plans and Pricing

Chile

Patent: 14001828
Estimated Expiration: See Plans and Pricing

China

Patent: 4136004
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 26611
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 87971
Estimated Expiration: See Plans and Pricing

Patent: 26611
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 97035
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 52301
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3644
Estimated Expiration: See Plans and Pricing

Japan

Patent: 14701
Estimated Expiration: See Plans and Pricing

Patent: 15508082
Estimated Expiration: See Plans and Pricing

Patent: 16053092
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 26611
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 5912
Estimated Expiration: See Plans and Pricing

Patent: 14008594
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 7593
Estimated Expiration: See Plans and Pricing

Poland

Patent: 26611
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 26611
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201403931Y
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1588259
Estimated Expiration: See Plans and Pricing

Patent: 140139496
Estimated Expiration: See Plans and Pricing

Spain

Patent: 09713
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 38657
Estimated Expiration: See Plans and Pricing

Patent: 1334780
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 631
Estimated Expiration: See Plans and Pricing

Patent: 283
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
France 2841783 FORME POSOLOGIQUE PHARMACEUTIQUE PORTANT UNE SIGNALISATION INDIQUANT UNE PARFAITE INNOCUITE EN CAS DE GROSSESSE See Plans and Pricing
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) See Plans and Pricing
Japan 6272561 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
McKinsey
Medtronic
Boehringer Ingelheim
AstraZeneca
Johnson and Johnson

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 verification 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.