Duloxetine hydrochloride - Generic Drug Details

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

Duloxetine hydrochloride is the generic ingredient in three branded drugs marketed by Lilly, Sun Pharm, Actavis Elizabeth, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Breckenridge, Cspc Ouyi, Endo Operations, Hetero Labs Ltd Iii, Inventia, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Prinston Inc, Qingdao Baheal Pharm, Sunshine, Teva Pharms Usa, Torrent, Yaopharma Co Ltd, Zydus Hlthcare, and Zydus Pharms, and is included in twenty-five NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Duloxetine hydrochloride has one patent family member in one country.

There are forty drug master file entries for duloxetine hydrochloride. Fifty suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for duloxetine hydrochloride

International Patents:	1
US Patents:	4
Tradenames:	3
Applicants:	24
NDAs:	25
Drug Master File Entries:	40
Finished Product Suppliers / Packagers:	50
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	356
Patent Applications:	677
What excipients (inactive ingredients) are in duloxetine hydrochloride?	duloxetine hydrochloride excipients list
DailyMed Link:	duloxetine hydrochloride at DailyMed

Recent Clinical Trials for duloxetine hydrochloride

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

Sponsor	Phase
National Cancer Institute, Egypt	Phase 4
Beni-Suef University	Phase 2
Institut Cancerologie de l'Ouest	Phase 3

See all duloxetine hydrochloride clinical trials

Generic filers with tentative approvals for DULOXETINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 60MG BASE	CAPSULE, DELAYED RELEASE; ORAL
⤷ Sign Up	⤷ Sign Up	EQ 30MG BASE	CAPSULE, DELAYED RELEASE; ORAL
⤷ Sign Up	⤷ Sign Up	EQ 20MG BASE	CAPSULE, DELAYED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for duloxetine hydrochloride

Drug Class	Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for duloxetine hydrochloride

Analgesics
Antidepressive Agents
Dopamine Agents
Serotonin and Noradrenaline Reuptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for duloxetine hydrochloride

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for DULOXETINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CYMBALTA	Delayed-release Capsules	duloxetine hydrochloride	40 mg	021427	1	2012-05-10
CYMBALTA	Delayed-release Capsules	duloxetine hydrochloride	20 mg, 30 mg and 60 mg	021427	16	2008-08-04

US Patents and Regulatory Information for duloxetine 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
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-004	Jul 19, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Inventia	DULOXETINE HYDROCHLORIDE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	202336-002	Oct 28, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Qingdao Baheal Pharm	DULOXETINE HYDROCHLORIDE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	210599-002	Apr 17, 2019	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

Expired US Patents for duloxetine hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-004	Aug 3, 2004	⤷ Sign Up	⤷ Sign Up
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-001	Aug 3, 2004	⤷ Sign Up	⤷ Sign Up
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-004	Aug 3, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for duloxetine hydrochloride

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3335697	ÉCLATS DE DULOXÉTINE (DULOXETINE SPRINKLES)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for duloxetine hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0273658	2005C/001	Belgium	⤷ Sign Up	PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
0273658	C300171	Netherlands	⤷ Sign Up	PRODUCT NAME: DULOXETINE EN FARMACEUTISCH AANVAARDBARE ZUURADDITIEZOUTEN DAARVAN, EN IN HET BIJZONDER DULOXETINE HYDROCHLORIDE; NATL REGISTRATION NO/DATE: EU/1/04/280/001-006 20040811
0273658	SPC/GB05/003	United Kingdom	⤷ Sign Up	PRODUCT NAME: DULOXETINE AND PHARMACUETICALLY ACCEPTABLE ACID ADDITION SALTS THEREOF, AND IN PARTICULAR DULOXETINE HYDROCHLORIDE; REGISTERED: UK EU/1/04/280/001 20040811; UK EU/1/04/280/002 20040811; UK EU/1/04/280/003 20040811; UK EU/1/04/280/004 20040811; UK EU/1/04/280/005 20040811; UK EU/1/04/280/006 20040811
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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