Duloxetine hydrochloride - Generic Drug Details
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What are the generic drug sources for duloxetine hydrochloride and what is the scope of patent protection?
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. Forty-nine 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: | 49 |
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 |
---|---|
Beni-Suef University | Phase 2 |
National Cancer Institute, Egypt | Phase 4 |
Grünenthal GmbH | Phase 3 |
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
Anatomical Therapeutic Chemical (ATC) Classes for duloxetine hydrochloride
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Torrent | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 090774-001 | Dec 11, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Alkem Labs Ltd | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 203197-003 | Aug 26, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sun Pharm | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 090745-001 | Dec 11, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lupin Ltd | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 090694-003 | Dec 11, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lupin Ltd | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 090694-004 | Dec 11, 2013 | 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
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 | 021427-002 | Aug 3, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-002 | 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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for duloxetine hydrochloride
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
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
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 | 2005C/001 | Belgium | ⤷ Sign Up | PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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