BONJESTA Drug Patent Profile
✉ Email this page to a colleague
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 19th, 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 |


Recent Clinical Trials for BONJESTA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Health Decisions | Phase 3 |
Duchesnay Inc. | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for BONJESTA
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 |
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 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |