CYMBALTA Drug Patent Profile
✉ Email this page to a colleague
When do Cymbalta patents expire, and what generic alternatives are available?
Cymbalta is a drug marketed by Lilly and is included in one NDA.
The generic ingredient in CYMBALTA is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Cymbalta
A generic version of CYMBALTA was approved as duloxetine hydrochloride by AUROBINDO PHARMA LTD on December 11th, 2013.
Summary for CYMBALTA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 197 |
| Clinical Trials: | 145 |
| Patent Applications: | 4,818 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CYMBALTA |
| What excipients (inactive ingredients) are in CYMBALTA? | CYMBALTA excipients list |
| DailyMed Link: | CYMBALTA at DailyMed |
Recent Clinical Trials for CYMBALTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Institut Cancerologie de l'Ouest | Phase 3 |
| Grünenthal GmbH | Phase 3 |
| Scripps Health | Phase 2 |
Pharmacology for CYMBALTA
| Drug Class | Serotonin and Norepinephrine Reuptake Inhibitor |
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for CYMBALTA
Paragraph IV (Patent) Challenges for CYMBALTA
| 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 CYMBALTA
CYMBALTA is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting CYMBALTA
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-001 | Aug 3, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-002 | Aug 3, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-004 | Aug 3, 2004 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >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 CYMBALTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-001 | Aug 3, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-002 | Aug 3, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-002 | Aug 3, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-001 | Aug 3, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-004 | Aug 3, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-004 | Aug 3, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CYMBALTA
See the table below for patents covering CYMBALTA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| New Zealand | 272554 | ENTERIC DULOXETINE PELLET USING HYDROXYPROPYLMETHYLCELLULOSE ACETATE SUCCINATE AS THE ENTERIC-COATING LAYER (DULOXETINE IS N-METHYL-3-(1-NAPHTHALENYLOXY)-2-THIOPHENE-PROPANAMINE) | ⤷ Try a Trial |
| Singapore | 114992 | ⤷ Try a Trial | |
| Denmark | 1113797 | ⤷ Try a Trial | |
| Hungary | 9502134 | ⤷ Try a Trial | |
| Portugal | 1113797 | ⤷ Try a Trial | |
| Canada | 2153856 | PASTILLES DE DULOXETINE A DELITAGE ENTERAL (DULOXETINE ENTERIC PELLETS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CYMBALTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0273658 | C300171 | Netherlands | ⤷ Try a Trial | 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 |
| 0693282 | PA2005001,C0693282 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DULOXETINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/04/280/001, EU/1/04/280/002, EU/1/04/280/003, EU/1/04/280/004, EU/1/04/280/005, EU/1/04/280/006 20040811 |
| 0273658 | 300171 | Netherlands | ⤷ Try a Trial | 300171, 20071218, EXPIRES: 20121217 |
| 0273658 | 91131 | Luxembourg | ⤷ Try a Trial | 91131, EXPIRES: 20121218 |
| 0273658 | C00273658/01 | Switzerland | ⤷ Try a Trial | PRODUCT: DULOXETIN; REG. NO/DATE: SWISSMEDIC 56727 20041217; DER WIDERRUF VOM 05.03.2009 ERFOLGTE IRRTUEMLICH |
| 0273658 | SPC/GB05/003 | United Kingdom | ⤷ Try a Trial | 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 |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2023 - 2024
NCE-1 Patent Challenge Dates 2023 - 2024
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - HIPAA-ready chat for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
Follow DrugPatentWatch:
