Doxylamine succinate - Generic Drug Details
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What are the generic sources for doxylamine succinate and what is the scope of freedom to operate?
Doxylamine succinate
is the generic ingredient in eight branded drugs marketed by Pfizer, Sanofi Aventis Us, Par Pharm, Copley Pharm, LNK, Perrigo, Quantum Pharmics, Chattem, Duchesnay, Actavis Labs Fl Inc, Bionpharma, Endo Operations, and Mylan Pharms Inc, and is included in sixteen NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are thirteen drug master file entries for doxylamine succinate. Thirty-one suppliers are listed for this compound.
Summary for doxylamine succinate
| US Patents: | 4 |
| Tradenames: | 8 |
| Applicants: | 13 |
| NDAs: | 16 |
| Drug Master File Entries: | 13 |
| Finished Product Suppliers / Packagers: | 31 |
| Raw Ingredient (Bulk) Api Vendors: | 95 |
| Clinical Trials: | 6 |
| Patent Applications: | 2,231 |
| What excipients (inactive ingredients) are in doxylamine succinate? | doxylamine succinate excipients list |
| DailyMed Link: | doxylamine succinate at DailyMed |
Recent Clinical Trials for doxylamine succinate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Jiangxi Maternal and Child Health Hospital | Phase 3 |
| Xiaoke Wu | Phase 3 |
| Hegang 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| 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 | |||
| Chattem | UNISOM | doxylamine succinate | TABLET;ORAL | 018066-001 | Approved Prior to Jan 1, 1982 | OTC | Yes | Yes | ⤷ 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 |
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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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