DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for doxylamine succinate; pyridoxine hydrochloride and what is the scope of freedom to operate?
Doxylamine succinate; pyridoxine hydrochloride
is the generic ingredient in four branded drugs marketed by Duchesnay, Actavis Labs Fl Inc, Bionpharma, Endo Operations, Mylan Pharms Inc, and Sanofi Aventis Us, and is included in eight NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Doxylamine succinate; pyridoxine hydrochloride has sixty-four patent family members in thirty-one countries.
Seven suppliers are listed for this compound.
Summary for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
International Patents: | 64 |
US Patents: | 4 |
Tradenames: | 4 |
Applicants: | 6 |
NDAs: | 8 |
Finished Product Suppliers / Packagers: | 7 |
Clinical Trials: | 4 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE |
DailyMed Link: | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Suihua Maternal and Child Health Hospital | Phase 3 |
Heilongjiang provincial hospital | Phase 3 |
Affiliated Hospital of Jiamusi Medical University | Phase 3 |
See all DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE clinical trials
Pharmacology for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Ingredient-type | Analogs/Derivatives Vitamin B 6 |
Drug Class | Antihistamine Vitamin B6 Analog |
Mechanism of Action | Histamine Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
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 |
DICLEGIS | Delayed-release Tablets | doxylamine succinate; pyridoxine hydrochloride | 10 mg/10 mg | 021876 | 1 | 2013-08-01 |
US Patents and Regulatory Information for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
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 | |||
Actavis Labs Fl Inc | DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | doxylamine succinate; pyridoxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212472-001 | Mar 1, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Duchesnay | DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876-001 | Apr 8, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Duchesnay | BONJESTA | doxylamine succinate; pyridoxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209661-001 | Nov 7, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Duchesnay | DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876-001 | Apr 8, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2014405049 | Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof | ⤷ Sign Up |
European Patent Office | 2787971 | FORMULATION DE DOXYLAMINE ET DE PYRIDOXINE ET/OU DE LEURS MÉTABOLITES OU SELS (FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF) | ⤷ Sign Up |
European Patent Office | 3326611 | FORMULATION DE DOXYLAMINE ET DE PYRIDOXINE ET/OU DE LEURS MÉTABOLITES OU SELS (FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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