CYMBALTA Drug Patent Profile
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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.
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Summary for CYMBALTA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 118 |
| Clinical Trials: | 147 |
| Patent Applications: | 4,249 |
| Drug Prices: | Drug price information for CYMBALTA |
| Drug Sales Revenues: | Drug sales revenues 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 |
|---|---|
| National Cancer Institute, Egypt | Phase 4 |
| Ain Shams University | Phase 4 |
| Grünenthal GmbH | Phase 3 |
Pharmacology for CYMBALTA
| Drug Class | Serotonin and Norepinephrine Reuptake Inhibitor |
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
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
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-002 | Aug 3, 2004 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427-004 | Aug 3, 2004 | AB | RX | Yes | Yes | ⤷ 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 CYMBALTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 | 021427-004 | 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 CYMBALTA
See the table below for patents covering CYMBALTA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| U.S.S.R. | 1598865 | CПOCOБ ПOЛУЧEHИЯ 3-APИЛOKCИ-3-ЗAMEЩEHHЫX ПPOПAHAMИHOB ИЛИ ИX ФAPMAKOЛOГИЧECKИ ПPИEMЛEMЫX KИCЛOTHO-AДДИTИBHЫX COЛEЙ (METHOD OF PRODUCING 3-ARYLOXY-3-SUBSTITUTED PROPANE AMINES OR THEIR PHARMACEUTICALLY ACCEPTABLE ACID-ADDITIVE SALTS) | ⤷ Sign Up |
| Norway | 952786 | ⤷ Sign Up | |
| Greece | 3036185 | ⤷ Sign Up | |
| Yugoslavia | 49445 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CYMBALTA
| 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 |
| 0693282 | PA2005001 | Lithuania | ⤷ Sign Up | 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 | 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 | 300171 | Netherlands | ⤷ Sign Up | 300171, 20071218, EXPIRES: 20121217 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 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.
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