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Amitriptyline hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for amitriptyline hydrochloride?

Amitriptyline hydrochloride is the generic ingredient in eighteen branded drugs marketed by Par Pharm, Roxane, Astrazeneca, Roche, Purepac Pharm, Mylan, Teva, Watson Labs, Sun Pharm Inds Inc, Vangard, Vintage Pharms, Copley Pharm, Halsey, Mutual Pharm, Ani Pharms Inc, Ucb Inc, Warner Chilcott, Lederle, Accord Hlthcare, West Ward, Superpharm, Bristol Myers Squibb, Sandoz, Am Therap, Usl Pharma, Pliva, Heritage Pharms Inc, Frontida Biopharm, Mylan Pharms Inc, Schering, New River, Ivax Sub Teva Pharms, and Sun Pharm Inds, and is included in one hundred and seventy-six NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: amitriptyline hydrochloride

Tradenames:18
Patents:1
Applicants:33
NDAs:176
Drug Master File Entries: see list13
Suppliers / Packagers: see list43
Bulk Api Vendors: see list49
Clinical Trials: see list1,017
Patent Applications: see list2,649
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:amitriptyline hydrochloride at DailyMed

Pharmacology for Ingredient: amitriptyline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride; perphenazine
TABLET;ORAL070373-001Aug 25, 1986DISCNNoNo► Subscribe► Subscribe
Lederle
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride
TABLET;ORAL087369-001Jan 4, 1982DISCNNoNo► Subscribe► Subscribe
Pliva
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride
TABLET;ORAL088885-001Sep 26, 1984DISCNNoNo► Subscribe► Subscribe
Lederle
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride
TABLET;ORAL087367-001May 3, 1982DISCNNoNo► Subscribe► Subscribe
Sandoz
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride
TABLET;ORAL085970-001Approved Prior to Jan 1, 1982RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: amitriptyline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
ELAVIL
amitriptyline hydrochloride
TABLET;ORAL012703-001Approved Prior to Jan 1, 19823,428,735► Subscribe
Astrazeneca
ELAVIL
amitriptyline hydrochloride
TABLET;ORAL012703-007Approved Prior to Jan 1, 19823,428,735► Subscribe
Astrazeneca
ELAVIL
amitriptyline hydrochloride
TABLET;ORAL012703-003Approved Prior to Jan 1, 19823,428,735► Subscribe
Astrazeneca
ELAVIL
amitriptyline hydrochloride
TABLET;ORAL012703-006Approved Prior to Jan 1, 19823,428,735► Subscribe
Astrazeneca
ELAVIL
amitriptyline hydrochloride
TABLET;ORAL012703-005Approved Prior to Jan 1, 19823,428,735► Subscribe
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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 verifification 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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