DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Doxylamine Succinate And Pyridoxine Hydrochloride, and what generic alternatives are available?
Doxylamine Succinate And Pyridoxine Hydrochloride is a drug marketed by Actavis Labs Fl Inc, Bionpharma, Endo Operations, and Mylan Pharms Inc. and is included in five NDAs.
The generic ingredient in DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE 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 Doxylamine Succinate And Pyridoxine Hydrochloride
A generic version of DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE was approved as doxylamine succinate; pyridoxine hydrochloride by ACTAVIS LABS FL INC on August 19th, 2016.
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Summary for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 4 |
NDAs: | 5 |
Finished Product Suppliers / Packagers: | 5 |
Clinical Trials: | 4 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE? | DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE excipients list |
DailyMed Link: | DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE at DailyMed |
![DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE drug patent expirations Drug patent expirations by year for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE](/p/graph/s/t/DOXYLAMINE_SUCCINATE_AND_PYRIDOXINE_HYDROCHLORIDE-patent-expirations.png)
Recent Clinical Trials for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Affiliated Hospital of Jiamusi Medical University | Phase 3 |
Mudanjaing Maternal and Child Health Hospital | Phase 3 |
Jiangxi Maternal and Child Health Hospital | Phase 3 |
See all DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE clinical trials
Pharmacology for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Ingredient-type | Analogs/Derivatives Vitamin B 6 |
Drug Class | Antihistamine Vitamin B6 Analog |
Mechanism of Action | Histamine Receptor Antagonists |
US Patents and Regulatory Information for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Actavis Labs Fl Inc | DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 205811-001 | Aug 19, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Mylan Pharms Inc | DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 207825-001 | Jul 6, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Bionpharma | DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 217000-001 | Aug 4, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |