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BONJESTA Drug Profile
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» See Plans and PricingWhen 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 fifty-one patent family members in twenty-seven countries.
The generic ingredient in BONJESTA is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Bonjesta
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for BONJESTA
| International Patents: | 51 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 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 |
| DailyMed Link: | BONJESTA at DailyMed |
Recent Litigation for BONJESTA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Duchesnay Inc. v. Mylan Pharmaceuticals Inc. | 2015-05-13 |
| Michael R Mastro | 2009-07-10 |
Pharmacology for BONJESTA
| Ingredient-type | Vitamin B 6 Analogs/Derivatives |
| Drug Class | Antihistamine Vitamin B6 Analog |
| Mechanism of Action | Histamine Receptor Antagonists |
Paragraph IV (Patent) Challenges for BONJESTA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BONJESTA | TABLET, EXTENDED RELEASE;ORAL | doxylamine succinate; pyridoxine hydrochloride | 209661 | 2018-08-28 |
US Patents and Regulatory Information for 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 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Duchesnay | BONJESTA | doxylamine succinate; pyridoxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209661-001 | Nov 7, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Duchesnay | BONJESTA | doxylamine succinate; pyridoxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209661-001 | Nov 7, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BONJESTA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2017525731 | Start Trial |
| Poland | 3185856 | Start Trial |
| South Korea | 20170046163 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
