DOXYLAMINE SUCCINATE Drug Patent Profile
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Which patents cover Doxylamine Succinate, and when can generic versions of Doxylamine Succinate launch?
Doxylamine Succinate is a drug marketed by Copley Pharm, LNK, Perrigo, Quantum Pharmics, Actavis Labs Fl Inc, Bionpharma, Mylan Pharms Inc, and Par Pharm Inc. and is included in nine NDAs.
The generic ingredient in DOXYLAMINE SUCCINATE 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
A generic version of DOXYLAMINE SUCCINATE was approved as doxylamine succinate; pyridoxine hydrochloride by ACTAVIS LABS FL INC on August 19th, 2016.
Summary for DOXYLAMINE SUCCINATE
US Patents: | 0 |
Applicants: | 8 |
NDAs: | 9 |
Finished Product Suppliers / Packagers: | 31 |
Raw Ingredient (Bulk) Api Vendors: | 95 |
Clinical Trials: | 6 |
Patent Applications: | 1,477 |
Formulation / Manufacturing: | see details |
DailyMed Link: | DOXYLAMINE SUCCINATE at DailyMed |
Recent Clinical Trials for DOXYLAMINE SUCCINATE
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 |
Pharmacology for DOXYLAMINE SUCCINATE
Drug Class | Antihistamine |
Mechanism of Action | Histamine Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for DOXYLAMINE SUCCINATE
Anatomical Therapeutic Chemical (ATC) Classes for DOXYLAMINE SUCCINATE
US Patents and Regulatory Information for DOXYLAMINE SUCCINATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Copley Pharm | DOXYLAMINE SUCCINATE | doxylamine succinate | TABLET;ORAL | 088900-002 | Feb 12, 1988 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Quantum Pharmics | DOXYLAMINE SUCCINATE | doxylamine succinate | TABLET;ORAL | 088603-001 | Aug 7, 1984 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |