Lexapro Drug Patent Profile
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Which patents cover Lexapro, and when can generic versions of Lexapro launch?
Lexapro is a drug marketed by Abbvie and is included in two NDAs.
The generic ingredient in LEXAPRO is escitalopram oxalate. There are twenty-six drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lexapro
A generic version of Lexapro was approved as escitalopram oxalate by AMNEAL PHARMS on March 14th, 2012.
Summary for Lexapro
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 91 |
Clinical Trials: | 161 |
Patent Applications: | 655 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for Lexapro |
Drug Sales Revenues: | Drug sales revenues for Lexapro |
What excipients (inactive ingredients) are in Lexapro? | Lexapro excipients list |
DailyMed Link: | Lexapro at DailyMed |
Recent Clinical Trials for Lexapro
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) | Phase 2/Phase 3 |
National Center for Complementary and Integrative Health (NCCIH) | Phase 2/Phase 3 |
University of Michigan | Phase 2/Phase 3 |
Pharmacology for Lexapro
Drug Class | Serotonin Reuptake Inhibitor |
Mechanism of Action | Serotonin Uptake Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for Lexapro
Paragraph IV (Patent) Challenges for LEXAPRO
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LEXAPRO | Capsules | escitalopram oxalate | 5 mg | 021323 | 1 | 2005-08-17 |
LEXAPRO | Capsules | escitalopram oxalate | 10 mg and 20 mg | 021323 | 1 | 2005-03-30 |
US Patents and Regulatory Information for Lexapro
Lexapro is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting Lexapro
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | LEXAPRO | escitalopram oxalate | SOLUTION;ORAL | 021365-001 | Nov 27, 2002 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-003 | Aug 14, 2002 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-001 | Aug 14, 2002 | AB | RX | Yes | No | ⤷ 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 Lexapro
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-002 | Aug 14, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-001 | Aug 14, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | LEXAPRO | escitalopram oxalate | SOLUTION;ORAL | 021365-001 | Nov 27, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for Lexapro
See the table below for patents covering Lexapro around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1660074 | ⤷ Try a Trial | |
European Patent Office | 1414435 | COMPOSITION CRISTALLINE RENFERMANT DE L'ESCITALOPRAM (CRYSTALLINE COMPOSITION CONTAINING ESCITALOPRAM) | ⤷ Try a Trial |
Portugal | 90845 | PROCESSO PARA A PREPARACAO DE NOVOS ENANTIOMEROS DO CITALOPRAM E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Lexapro
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0347066 | 2002C/039 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ESCITALOPRAM. OXALAT. (INN) ESCITALOPRAM; NATL. REGISTRATION NO/DATE: 7004 IE10 F 3 20020729; FIRST REGISTRATION: SE 17084 20011207 |
0347066 | SZ 42/2002 | Austria | ⤷ Try a Trial | |
0347066 | 10399030 | Germany | ⤷ Try a Trial | PRODUCT NAME: ESCITALOPRAMOXALAT; NAT. REGISTRATION NO/DATE: 55880.00.00 55880.01.00 55880.02.00 55880.03.00 55884.00.00 55884.01.00 55884.02.00 55884.03.00 55888.00.00 55888.01.00 55888.02.00 55888.03.00 20030408 FIRST REGISTRATION: SCHWEDEN 17084 17085 17086 17087 20011207 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |