Amitriptyline hydrochloride - Generic Drug Details

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What are the generic drug sources for amitriptyline hydrochloride and what is the scope of freedom to operate?

Amitriptyline hydrochloride is the generic ingredient in eighteen branded drugs marketed by Roche, Watson Labs, Astrazeneca, Bristol Myers Squibb, Warner Chilcott, Accord Hlthcare, Aiping Pharm Inc, Am Therap, Ani Pharms, Aurobindo Pharma Usa, Breckenridge, Copley Pharm, Endo Operations, Halsey, Lederle, Mankind Pharma, Mutual Pharm, Par Pharm, Pliva, Purepac Pharm, Rising, Roxane, Rubicon, Sandoz, Sun Pharm Inds Inc, Superpharm, Teva, Ucb Inc, Unichem, Usl Pharma, Vangard, West Ward, Zydus Pharms, Anda Repository, Chartwell Rx, Heritage Pharma, Micro Labs, Mylan Pharms Inc, Schering, Fosun Pharma, Ivax Sub Teva Pharms, Mylan, Sun Pharm Industries, and New River, and is included in one hundred and seventy-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for amitriptyline hydrochloride. Forty-three suppliers are listed for this compound.

Summary for amitriptyline hydrochloride

US Patents:	0
Tradenames:	18
Applicants:	44
NDAs:	179
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	125
Patent Applications:	4,166
What excipients (inactive ingredients) are in amitriptyline hydrochloride?	amitriptyline hydrochloride excipients list
DailyMed Link:	amitriptyline hydrochloride at DailyMed

Recent Clinical Trials for amitriptyline hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Shalamar Institute of Health Sciences	N/A
Beni-Suef University	Phase 2
Children's Hospital Medical Center, Cincinnati	N/A

See all amitriptyline hydrochloride clinical trials

Pharmacology for amitriptyline hydrochloride

Drug Class	Tricyclic Antidepressant

Medical Subject Heading (MeSH) Categories for amitriptyline hydrochloride

Adrenergic Uptake Inhibitors
Analgesics, Non-Narcotic
Antidepressive Agents, Tricyclic

Anatomical Therapeutic Chemical (ATC) Classes for amitriptyline hydrochloride

N06AA	Non-selective monoamine reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for amitriptyline hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Micro Labs	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	211925-001	Feb 2, 2022	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Rubicon	AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride	TABLET;ORAL	215376-002	May 1, 2023	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
New River	TRIAVIL 2-10	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014715-004	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Teva	AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride	TABLET;ORAL	086853-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
West Ward	AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride	TABLET;ORAL	087278-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Bristol Myers Squibb	AMITID	amitriptyline hydrochloride	TABLET;ORAL	086454-005	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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 amitriptyline hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-007	Approved Prior to Jan 1, 1982	3,428,735	⤷ Subscribe
Astrazeneca	ELAVIL	amitriptyline hydrochloride	INJECTABLE;INJECTION	012704-001	Approved Prior to Jan 1, 1982	3,428,735	⤷ Subscribe
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-006	Approved Prior to Jan 1, 1982	3,428,735	⤷ Subscribe
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-004	Approved Prior to Jan 1, 1982	3,428,735	⤷ Subscribe
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-005	Approved Prior to Jan 1, 1982	3,428,735	⤷ Subscribe
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-003	Approved Prior to Jan 1, 1982	3,428,735	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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