DrugPatentWatch Database Preview
LEXAPRO Drug Profile
When do Lexapro patents expire, and when can generic versions of Lexapro launch?
Lexapro is a drug marketed by Allergan Sales Llc and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.
This drug has fifty-six patent family members in thirty-eight countries.
The generic ingredient in LEXAPRO is escitalopram oxalate. There are twenty-six drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.
Summary for LEXAPRO
| International Patents: | 56 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 9 |
| Bulk Api Vendors: | 112 |
| Clinical Trials: | 86 |
| Patent Applications: | 3,503 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LEXAPRO |
| Drug Sales Revenues: | Drug sales revenues for LEXAPRO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LEXAPRO |
| DailyMed Link: | LEXAPRO at DailyMed |
Recent Clinical Trials for LEXAPRO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Texas Southwestern Medical Center | Phase 4 |
| Zhejiang University | Early Phase 1 |
| The University of Hong Kong | Phase 2/Phase 3 |
Recent Litigation for LEXAPRO
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Alza Corporation v. Impax Laboratories Inc. | 2005-09-01 |
| Forest Laboratories v. Ivax Pharmaceuticals |
Pharmacology for LEXAPRO
| Drug Class | Serotonin Reuptake Inhibitor |
| Mechanism of Action | Serotonin Uptake Inhibitors |
Synonyms for LEXAPRO
| (+)-(S)-1-(3-(Dimethylamino)propyl)-1-(p-fluorophenyl)-5-phthalancarbonitrile |
| (+)-(S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofurancarbonitrile oxalate |
| (+)-(S)-Citalopram oxalate |
| (+)-Citalopram |
| (1r)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-3h-isobenzofuran-5-carbonitrile |
| (1S)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile |
| (1S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofurancarbonitrile Ethanedioate |
| (1S)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3H-2-benzofuran-5-carbonitrile |
| (1S)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3H-2-benzofuran-5-carbonitrile; oxalic acid |
| (1S)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3H-2-benzofuran-5-carbonitrile;oxalic acid |
| (1S)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3H-isobenzofuran-5-carbonitrile |
| (1S)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3H-isobenzofuran-5-carbonitrile; oxalic acid |
| (S)-(+)-1-[3-(dimethylamino) propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofuran carbonitrile |
| (S)-(+)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofuran carbonitrile |
| (S)-(+)-Citalopram Oxalate |
| (S)-(+)Citalopram oxalate |
| (s)-1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile |
| (S)-1-(3-(Dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile oxalate |
| (s)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5 carbonitrile |
| (S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile Oxalate |
| (S)-Citalopram |
| (S)-Citalopram Oxalate |
| 1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile |
| 118335-EP2275420A1 |
| 118335-EP2298764A1 |
| 118335-EP2298765A1 |
| 128196-01-0 |
| 219861-08-2 |
| 4O4S742ANY |
| 5-Isobenzofurancarbonitrile, 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydro-, (1S)- |
| 5-Isobenzofurancarbonitrile, 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydro-, (1S)-, ethanedioate (1:1) |
| 5U85DBW7LO |
| 68P |
| 861E082 |
| AB0012102 |
| AB00698374_10 |
| AB00698374-07 |
| AB00698374-09 |
| AC-4508 |
| AC-6770 |
| AC1L3TGW |
| AC1L3TGZ |
| AJ-45648 |
| AKOS016340275 |
| AKOS017343470 |
| AN-11923 |
| AN-13009 |
| AN-14764 |
| AN-9671 |
| AOB4715 |
| API0010346 |
| AX8019428 |
| B1183 |
| BCP05686 |
| BCP12154 |
| BDBM50302225 |
| BG0433 |
| BIDD:PXR0135 |
| BRD-K70301876-034-02-0 |
| BSPBio_002644 |
| C22H23FN2O5 |
| CAS-219861-08-2 |
| cc-372 |
| CCG-39559 |
| CHEBI:36791 |
| CHEMBL1200322 |
| CHEMBL1508 |
| Cipralex |
| Citalopram Oxalate |
| CPD000469191 |
| CS-2053 |
| CS-2054 |
| CTK8E9353 |
| D02567 |
| D07913 |
| DB01175 |
| DSSTox_CID_26003 |
| DSSTox_GSID_46003 |
| DSSTox_RID_81282 |
| DTXSID1046003 |
| DTXSID8048440 |
| E0958 |
| EBD32686 |
| Entact |
| Escitalopram |
| Escitalopram (INN) |
| Escitalopram (oxalate) |
| Escitalopram [INN:BAN] |
| Escitalopram [INN] |
| Escitalopram for system suitability, EuropePharmacopoeia (EP) Reference Standard |
| Escitalopram oxalate |
| Escitalopram oxalate (JAN/USAN) |
| Escitalopram oxalate [USAN:USP] |
| Escitalopram oxalate [USAN] |
| escitalopram oxalate inn |
| Escitalopram oxalate, >=98% (HPLC), powder |
| Escitalopram oxalate, EuropePharmacopoeia (EP) Reference Standard |
| Escitalopram Oxalate, Pharmaceutical Secondary Standard; Certified Reference Material |
| Escitalopram oxalate, United States Pharmacopeia (USP) Reference Standard |
| Escitalopram pound Escitalopram Oxalate pound(c) |
| escitalopramum |
| Esertia |
| Esertia (TN) |
| FT-0650410 |
| FT-0660873 |
| Gaudium |
| GTPL7177 |
| HMS2051D11 |
| HMS2089O08 |
| HMS2231M16 |
| HMS3370I17 |
| HMS3393D11 |
| HMS3713D16 |
| HY-14258 |
| HY-14258A |
| J-005570 |
| J90016 |
| KB-62485 |
| KBio2_001881 |
| KBio2_004449 |
| KBio2_007017 |
| KBio3_001864 |
| KBioGR_001644 |
| KBioSS_001881 |
| KS-1263 |
| KTGRHKOEFSJQNS-BDQAORGHSA-N |
| Lexapro (TN) |
| Lopac-C-7861 |
| LS-183517 |
| LS-183519 |
| Lu 26-054-0 |
| Lu-26-054-0 |
| LU-260540 |
| MLD-55 |
| MLS001401408 |
| MolPort-003-666-613 |
| MRF-0000226 |
| NC00194 |
| NCGC00015267-01 |
| NCGC00015267-02 |
| NCGC00015267-03 |
| NCGC00015267-06 |
| NCGC00025160-01 |
| NCGC00095903-01 |
| NCGC00178555-01 |
| NCGC00178555-02 |
| NSC-758934 |
| NSC758934 |
| Pharmakon1600-01505216 |
| RT-012495 |
| S-(+)-1-(3-(Dimethylamino)propyl)-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate |
| S-(+)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofurancarbonitrile oxalate |
| S-(+)-5-Isobenzofurancarbonitrile, 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydro-, oxalate |
| S-(+)-Citalopram |
| S(+)-Citalopram |
| SAM001246668 |
| SB17453 |
| SB17454 |
| SC-47288 |
| SCHEMBL34948 |
| SCHEMBL35123 |
| Seroplex |
| SMR000469191 |
| SPBio_000621 |
| Spectrum_001401 |
| SPECTRUM1505216 |
| Spectrum2_000551 |
| Spectrum3_001062 |
| Spectrum4_001212 |
| Spectrum5_001693 |
| SR-01000763053 |
| SR-01000763053-3 |
| ST24046691 |
| TL8001823 |
| Tocris-1427 |
| Tox21_111535 |
| Tox21_111535_1 |
| UNII-0DHU5B8D6V component WSEQXVZVJXJVFP-FQEVSTJZSA-N |
| UNII-4O4S742ANY |
| UNII-5U85DBW7LO |
| UNII-B5RDX2419X component KTGRHKOEFSJQNS-BDQAORGHSA-N |
| WSEQXVZVJXJVFP-FQEVSTJZSA-N |
| ZINC3800706 |
US Patents and Regulatory Information for LEXAPRO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan Sales Llc | LEXAPRO | escitalopram oxalate | SOLUTION;ORAL | 021365-001 | Nov 27, 2002 | AA | RX | Yes | Yes | See Pricing | See Pricing | See Pricing | |||
| Allergan Sales Llc | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-003 | Aug 14, 2002 | AB | RX | Yes | Yes | See Pricing | See Pricing | Y | See Pricing | ||
| Allergan Sales Llc | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-002 | Aug 14, 2002 | AB | RX | Yes | No | See Pricing | See Pricing | Y | See Pricing | ||
| Allergan Sales Llc | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-001 | Aug 14, 2002 | AB | RX | Yes | No | See Pricing | See Pricing | Y | See Pricing | ||
| Allergan Sales Llc | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-001 | Aug 14, 2002 | AB | RX | Yes | No | See Pricing | See Pricing | Y | See Pricing | ||
| >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 |
|---|---|---|---|---|---|---|---|
| Allergan Sales Llc | LEXAPRO | escitalopram oxalate | SOLUTION;ORAL | 021365-001 | Nov 27, 2002 | See Pricing | See Pricing |
| Allergan Sales Llc | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-002 | Aug 14, 2002 | See Pricing | See Pricing |
| Allergan Sales Llc | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-003 | Aug 14, 2002 | See Pricing | See Pricing |
| Allergan Sales Llc | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-001 | Aug 14, 2002 | See Pricing | See Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for LEXAPRO
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Capsules | 5 mg | ➤ Subscribe | See Pricing |
| ➤ Subscribe | Capsules | 10 mg and 20 mg | ➤ Subscribe | See Pricing |
International Patents for LEXAPRO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 1311819 | See Pricing |
| Japan | 4971477 | See Pricing |
| Hungary | 0401946 | See Pricing |
| Denmark | 1414435 | See Pricing |
| Morocco | 27349 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LEXAPRO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0347066 | SPC/GB02/049 | United Kingdom | See Pricing | 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 | C300155 | Netherlands | See Pricing | 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 | See Pricing | PRODUCT NAME: ESCITALOPRAM. OXALAT. (INN) ESCITALOPRAM; NATL. REGISTRATION NO/DATE: 7004 IE10 F 3 20020729; FIRST REGISTRATION: SE 17084 20011207 |
| 0347066 | 42/2002 | Austria | See Pricing | 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 | 10399030 | Germany | See Pricing | 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 |
