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Escitalopram oxalate - Generic Drug Details
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What are the generic sources for escitalopram oxalate and what is the scope of patent protection?
Escitalopram oxalate
is the generic ingredient in two branded drugs marketed by Mylan Pharms Inc, Amneal Pharms, Antrim Pharms Llc, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Lannett Co Inc, Macleods Pharms Ltd, Taro, Allergan, Accord Hlthcare, Cadila, Hikma Pharms, Invagen Pharms, Jubilant Generics, Lupin Ltd, Mylan, Pharm Assoc, Prinston Inc, Rising, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in twenty-five NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Escitalopram oxalate has fifty-six patent family members in thirty-eight countries.
There are twenty-six drug master file entries for escitalopram oxalate. Forty-four suppliers are listed for this compound. There are six tentative approvals for this compound.
Summary for escitalopram oxalate
| International Patents: | 56 |
| US Patents: | 2 |
| Tradenames: | 2 |
| Applicants: | 21 |
| NDAs: | 25 |
| Drug Master File Entries: | 26 |
| Suppliers / Packagers: | 44 |
| Bulk Api Vendors: | 73 |
| Clinical Trials: | 17 |
| Patent Applications: | 785 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for escitalopram oxalate |
| Drug Sales Revenues: | Drug sales revenues for escitalopram oxalate |
| DailyMed Link: | escitalopram oxalate at DailyMed |
Recent Clinical Trials for escitalopram oxalate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Xijing Hospital | N/A |
| GlaxoSmithKline | Phase 3 |
| Guangdong Provincial Hospital of Traditional Chinese Medicine | N/A |
Generic filers with tentative approvals for ESCITALOPRAM OXALATE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 20MG | TABLET; ORAL |
| Start Trial | Start Trial | 10MG | TABLET; ORAL |
| Start Trial | Start Trial | 5MG | TABLET; 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 escitalopram oxalate
| Drug Class | Serotonin Reuptake Inhibitor |
| Mechanism of Action | Serotonin Uptake Inhibitors |
Paragraph IV (Patent) Challenges for ESCITALOPRAM OXALATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LEXAPRO | TABLET;ORAL | escitalopram oxalate | 021323 | 2005-08-17 |
| LEXAPRO | TABLET;ORAL | escitalopram oxalate | 021323 | 2005-03-30 |
US Patents and Regulatory Information for escitalopram oxalate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Prinston Inc | ESCITALOPRAM OXALATE | escitalopram oxalate | TABLET;ORAL | 078032-003 | Aug 28, 2015 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Accord Hlthcare | ESCITALOPRAM OXALATE | escitalopram oxalate | TABLET;ORAL | 202389-002 | Sep 11, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Torrent Pharms Ltd | ESCITALOPRAM OXALATE | escitalopram oxalate | TABLET;ORAL | 090939-003 | Sep 11, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Torrent Pharms Ltd | ESCITALOPRAM OXALATE | escitalopram oxalate | TABLET;ORAL | 090939-002 | Sep 11, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start 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 escitalopram oxalate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Allergan | LEXAPRO | escitalopram oxalate | SOLUTION;ORAL | 021365-001 | Nov 27, 2002 | Start Trial | Start Trial |
| Allergan | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-002 | Aug 14, 2002 | Start Trial | Start Trial |
| Allergan | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-003 | Aug 14, 2002 | Start Trial | Start Trial |
| Allergan | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-001 | Aug 14, 2002 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for escitalopram oxalate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Malaysia | 126238 | Start Trial |
| Germany | 60202615 | Start Trial |
| Slovenia | 1414435 | Start Trial |
| Serbia | 8304 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for escitalopram oxalate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0347066 | SPC/GB02/049 | United Kingdom | Start Trial | 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 | Start Trial | 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 | 2002C/039 | Belgium | Start Trial | PRODUCT NAME: ESCITALOPRAM. OXALAT. (INN) ESCITALOPRAM; NATL. REGISTRATION NO/DATE: 7004 IE10 F 3 20020729; FIRST REGISTRATION: SE 17084 20011207 |
| 0347066 | 10399030 | Germany | Start 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 |
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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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