LEXAPRO Drug Patent Profile
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Which patents cover Lexapro, and what generic alternatives are available?
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.
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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 |
| 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 |
|---|---|
| University of Michigan | Phase 2/Phase 3 |
| National Institute of Neurological Disorders and Stroke (NINDS) | Phase 2/Phase 3 |
| National Center for Complementary and Integrative Health (NCCIH) | Phase 2/Phase 3 |
Pharmacology for LEXAPRO
| Drug Class | Serotonin Reuptake Inhibitor |
| Mechanism of Action | Serotonin Uptake Inhibitors |
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
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Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-003 | Aug 14, 2002 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-001 | Aug 14, 2002 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-002 | Aug 14, 2002 | AB | RX | Yes | 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 LEXAPRO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-003 | Aug 14, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-002 | Aug 14, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-003 | Aug 14, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | LEXAPRO | escitalopram oxalate | SOLUTION;ORAL | 021365-001 | Nov 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-003 | Aug 14, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-001 | Aug 14, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Tunisia | SN04021 | CRYSTALLINE COMPOSITION CONTAINING ESCITALOPRAM | ⤷ Sign Up |
| Portugal | 1414435 | ⤷ Sign Up | |
| Montenegro | P2108 | ⤷ Sign Up | |
| Hungary | 0401946 | ⤷ Sign Up | |
| Norway | 892447 | ⤷ Sign Up | |
| Colombia | 5560540 | COMPOSICION CRISTALINA QUE CONTIENE ESCITALOPRAM | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LEXAPRO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0347066 | 90999 | Luxembourg | ⤷ Sign Up | |
| 0347066 | SPC/GB02/049 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ESCITALOPRAM OXALATE; REGISTERED: SE 17084/85/86/87 20011207; UK PL 13761/0008 20020610; UK PC 13761/0009 20020610; UK PL 13761/0010 20020610; UK PL 13761/0011 20020610; UK PL 13761/0012 20020610; UK PL 13761/0013 20020610; UK PL 13761/00014 20020610; UK PL 13761/0015 20020610 |
| 0347066 | 42/2002 | Austria | ⤷ Sign Up | PRODUCT NAME: ESCITALOPRAM UND DESSEN NICHT-TOXISCHE SAEUREADDITIONSSALZE; NAT. REGISTRATION NO/DATE: 1-24549, 1-24550, 1-24551, 1-24552 20020618; FIRST REGISTRATION: SE 17084, 17085, 17086,17087 20011207 |
| 0347066 | SZ 42/2002 | Austria | ⤷ Sign Up | |
| 0347066 | C300155 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ESCITALOPRAM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER ESCITALOPRAMOXALAAT; REGISTRATION NO/DATE: RVG 30490 - RVG 30497 20040427 |
| 0347066 | 2002C/039 | Belgium | ⤷ Sign Up | PRODUCT NAME: ESCITALOPRAM. OXALAT. (INN) ESCITALOPRAM; NATL. REGISTRATION NO/DATE: 7004 IE10 F 3 20020729; FIRST REGISTRATION: SE 17084 20011207 |
| >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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