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-four patent family members in thirty-one countries.
The generic ingredient in BONJESTA is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Seven 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.
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Summary for BONJESTA
| International Patents: | 64 |
| 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 |
Pharmacology for BONJESTA
| Ingredient-type | Analogs/Derivatives Vitamin B 6 |
| Drug Class | Antihistamine Vitamin B6 Analog |
| Mechanism of Action | Histamine Receptor Antagonists |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Duchesnay | BONJESTA | doxylamine succinate; pyridoxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209661-001 | Nov 7, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Duchesnay | BONJESTA | doxylamine succinate; pyridoxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209661-001 | Nov 7, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Duchesnay | BONJESTA | doxylamine succinate; pyridoxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209661-001 | Nov 7, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| >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
Patent: COMPOSICION DE DOXILAMINA Y PIRIDOXINA Y/O SUS METABOLITOS O SALES
Estimated Expiration: ⤷ Sign Up
Patent: 2580
Patent: FORMA DE DOSIFICACIÓN DE DOXILAMINA Y PIRIDOXINA Y/O SUS METABOLITOS O SALES
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 13224598
Patent: Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2014020186
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 48798
Patent: FORMULATION DE DOXYLAMINE ET DE PYRIDOXINE ET/OU DE LEURS METABOLITES OU SELS (FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 14001828
Patent: Sistema de dosificacion oral de liberacion dual que comprende doxilamina y piridoxina y/o sus analogos, metabolitos y sales de los mismos; forma de dosificacion oral de liberacion dual; kit farmaceutico; uso para aliviar los sintomas de nauseas y vomitos, incluidos los del embarazo.
Estimated Expiration: ⤷ Sign Up
China
Patent: 4136004
Patent: Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 23122
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 26611
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 87971
Patent: FORMULATION DE DOXYLAMINE ET DE PYRIDOXINE ET/OU DE LEURS MÉTABOLITES OU SELS (FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 26611
Patent: FORMULATION DE DOXYLAMINE ET DE PYRIDOXINE ET/OU DE LEURS MÉTABOLITES OU SELS (FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 97035
Patent: 多西拉敏和吡哆醇和/或其代謝物或鹽的製劑 (FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND OR METABOLITES OR SALTS THEREOF)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 52301
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 3644
Patent: צורות מינון בעלות שחרור דואלי הניתנות דרך הפה אשר מכילות דוקסילאמין ופירידוקסין, ערכות המכילות אותן ושימושן להקלת סימפטומים של בחילה והקאה (Dual release oral dosage forms comprising doxylamine and pyridoxine, kits comprising them and their use in alleviating the symptoms of nausea and vomiting)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 14701
Estimated Expiration: ⤷ Sign Up
Patent: 15508082
Patent: ドキシラミンおよびピリドキシン、ならびに／またはその代謝物もしくは塩の製剤
Estimated Expiration: ⤷ Sign Up
Patent: 16053092
Patent: ドキシラミンおよびピリドキシン、ならびに／またはその代謝物もしくは塩の製剤 (FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 26611
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 5912
Patent: FORMULACIÓN DE DOXILAMINA Y PIRIDOXINA Y/O SUS METABOLITOS O SALES. (FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF.)
Estimated Expiration: ⤷ Sign Up
Patent: 14008594
Patent: FORMULACION DE DOXILAMINA Y PIRIDOXINA Y/O SUS METABOLITOS O SALES. (FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 7593
Patent: Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 26611
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 26611
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201403931Y
Patent: FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1588259
Estimated Expiration: ⤷ Sign Up
Patent: 140139496
Patent: FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 09713
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 38657
Estimated Expiration: ⤷ Sign Up
Patent: 1334780
Patent: Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 631
Patent: FORMULACIÓN DE DOXILAMINA Y PIRIDOXINA Y/O SUS METABOLITOS O SALES
Estimated Expiration: ⤷ Sign Up
Patent: 283
Patent: FORMULACIÓN DE LIBERACIÓN PLURIMODAL DE DOXILAMINA Y PIRIDOXINA Y/O METABOLITOS O SALES DE LAS MISMAS
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Saudi Arabia | 517380942 | صيغة إطلاق متعددة النماذج للدوكسيلامين والبيريدوكسين و/أو نواتج أيض أو أملاح منها (Plurimodal Release Formulation of Doxylamine and Pyridoxine and/or Metabolites or Salts Thereof) | ⤷ Sign Up |
| Belgium | 1016043 | FORME POSOLOGIQUE PHARMACEUTIQUE PORTANT UNE SIGNALETIQUE INDIQUANT UNE PARFAITE INNOCUITE EN CAS DE GROSSESSE. | ⤷ Sign Up |
| Hungary | E052301 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2016029290 | ⤷ Sign Up | |
| Hong Kong | 1197035 | 多西拉敏和吡哆醇和/或其代謝物或鹽的製劑 (FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND OR METABOLITES OR SALTS THEREOF) | ⤷ Sign Up |
| Israel | 250541 | פורמולציות שחרור פלורימודלי של דוקסילאמין ופירידוקסין ו/או מטבוליטים או מלחים שלהם (Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
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