Glaxo Company Profile
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What is the competitive landscape for GLAXO, and what generic alternatives to GLAXO drugs are available?
GLAXO has one hundred and fifty-eight approved drugs.
There are thirty-six US patents protecting GLAXO drugs.
There are seven hundred and fifty-seven patent family members on GLAXO drugs in fifty-nine countries and one hundred and eighty-five supplementary protection certificates in twenty countries.
Summary for Glaxo
| International Patents: | 757 |
| US Patents: | 36 |
| Tradenames: | 116 |
| Ingredients: | 93 |
| NDAs: | 158 |
| Drug Master File Entries: | 1 |
| Patent Litigation for Glaxo: | See patent lawsuits for Glaxo |
| PTAB Cases with Glaxo as petitioner: | See PTAB cases with Glaxo as petitioner |
Drugs and US Patents for Glaxo
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | BACTROBAN | mupirocin calcium | CREAM;TOPICAL | 050746-001 | Dec 11, 1997 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxosmithkline | PHYTONADIONE | phytonadione | INJECTABLE;INJECTION | 084060-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-003 | May 14, 2004 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxosmithkline | TOTACILLIN | ampicillin/ampicillin trihydrate | FOR SUSPENSION;ORAL | 062223-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxosmithkline Llc | LANOXICAPS | digoxin | CAPSULE;ORAL | 018118-003 | Jul 26, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-004 | May 8, 2009 | AB | RX | Yes | No | ⤷ 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 Glaxo
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | 5,225,445*PED | ⤷ Try a Trial |
| Glaxo Grp Ltd | ZANTAC 300 | ranitidine hydrochloride | TABLET;ORAL | 018703-002 | Dec 9, 1985 | 4,128,658 | ⤷ Try a Trial |
| Glaxo Grp Ltd | ZANTAC 150 | ranitidine hydrochloride | TABLET;ORAL | 018703-001 | Jun 9, 1983 | 4,521,431*PED | ⤷ Try a Trial |
| Glaxo Grp Ltd | FLOVENT DISKUS 100 | fluticasone propionate | POWDER;INHALATION | 020833-002 | Sep 29, 2000 | 6,032,666*PED | ⤷ Try a Trial |
| Glaxosmithkline | ZYBAN | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020711-003 | May 14, 1997 | 5,358,970 | ⤷ Try a Trial |
| Glaxo Grp Ltd | FLOVENT DISKUS 250 | fluticasone propionate | POWDER;INHALATION | 020833-003 | Sep 29, 2000 | 6,536,427*PED | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for GLAXO drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Oral Suspension | 750 mg/5 mL | ➤ Subscribe | 2009-10-20 |
| ➤ Subscribe | Extended-release Tablets | 4 mg | ➤ Subscribe | 2008-10-31 |
| ➤ Subscribe | Extended-release Tablets | 3 mg | ➤ Subscribe | 2009-01-08 |
| ➤ Subscribe | Extended-release Tablets | 2 mg | ➤ Subscribe | 2008-10-14 |
| ➤ Subscribe | Extended-release Tablets | 3 mg | ➤ Subscribe | 2009-01-08 |
| ➤ Subscribe | Injection | 6 mg/0.5 mL, 0.5 mL vials | ➤ Subscribe | 2004-10-25 |
| ➤ Subscribe | Tablets | 0.25 mg, 0.5 mg, 1 mg and 2 mg | ➤ Subscribe | 2004-12-22 |
| ➤ Subscribe | Tablets | 100 mg | ➤ Subscribe | 2007-10-31 |
| ➤ Subscribe | Tablets | 62.5 mg/25 mg | ➤ Subscribe | 2010-09-14 |
| ➤ Subscribe | Extended-release Capsules | 225 mg and 425 mg | ➤ Subscribe | 2006-10-11 |
| ➤ Subscribe | Extended-release Tablets | 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg | ➤ Subscribe | 2014-02-12 |
| ➤ Subscribe | Extended-release Tablets | 8 mg | ➤ Subscribe | 2008-11-03 |
| ➤ Subscribe | Extended-release Tablets | 12 mg | ➤ Subscribe | 2009-02-05 |
| ➤ Subscribe | Extended-release Tablets | 6 mg | ➤ Subscribe | 2009-07-22 |
| ➤ Subscribe | Tablets | 150 mg | ➤ Subscribe | 2007-10-30 |
| ➤ Subscribe | Orally Disintegrating Tablets | 25 mg, 50 mg, 100 mg, and 200 mg | ➤ Subscribe | 2009-12-21 |
| ➤ Subscribe | Injection | 6 mg/0.5 mL, 0.5 mL (prefilled syringes) | ➤ Subscribe | 2006-05-09 |
| ➤ Subscribe | Tablets | 3 mg, 4 mg and 5 mg | ➤ Subscribe | 2005-02-04 |
| ➤ Subscribe | Tablets | 250 mg/100 mg | ➤ Subscribe | 2009-04-03 |
| ➤ Subscribe | Extended-release Capsules | 325 mg | ➤ Subscribe | 2006-11-07 |
International Patents for Glaxo Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Dominican Republic | P2009000170 | ⤷ Try a Trial |
| Australia | 2007260837 | ⤷ Try a Trial |
| Hong Kong | 1201762 | ⤷ Try a Trial |
| Portugal | 1467789 | ⤷ Try a Trial |
| Australia | 2021204302 | ⤷ Try a Trial |
| Russian Federation | 2010133241 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Glaxo Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2109608 | CA 2018 00017 | Denmark | ⤷ Try a Trial | PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE; REG. NO/DATE: EU/1/17/1235 20171120 |
| 1480644 | SPC/GB17/004 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: COMBINATION OF CEFTAZIDIME, OR A SALT THEREOF, AND AVIBACTAM, OR A SALT THEREOF; REGISTERED: UK EU/1/16/1109/001 20160628 |
| 0299602 | 97C0036 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702 |
| 2506844 | LUC00077 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117 |
| 1425001 | CA 2014 00021 | Denmark | ⤷ Try a Trial | PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131113 |
| 2316456 | C201730057 | Spain | ⤷ Try a Trial | PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
