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Glaxosmithkline Company Profile
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What is the competitive landscape for GLAXOSMITHKLINE, and when can generic versions of GLAXOSMITHKLINE drugs launch?
GLAXOSMITHKLINE has one hundred and eighty-five approved drugs.
There are fifty US patents protecting GLAXOSMITHKLINE drugs.
There are one thousand and seventy-five patent family members on GLAXOSMITHKLINE drugs in fifty-nine countries and one hundred and ninety-two supplementary protection certificates in twenty countries.
Summary for Glaxosmithkline
| International Patents: | 1075 |
| US Patents: | 50 |
| Tradenames: | 135 |
| Ingredients: | 108 |
| NDAs: | 185 |
| Drug Master File Entries: | 8 |
| Patent Litigation for Glaxosmithkline: | See patent lawsuits for Glaxosmithkline |
| PTAB Cases with Glaxosmithkline as petitioner: | See PTAB cases with Glaxosmithkline as petitioner |
Drugs and US Patents for Glaxosmithkline
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | NIX | permethrin | LOTION;TOPICAL | 019435-001 | Mar 31, 1986 | DISCN | No | No | Start Trial | Start Trial | |||||
| Glaxosmithkline | ZYBAN | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020711-002 | May 14, 1997 | DISCN | No | No | Start Trial | Start Trial | |||||
| Glaxosmithkline | CLOXAPEN | cloxacillin sodium | CAPSULE;ORAL | 061806-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | |||||
| Glaxosmithkline | NALLPEN | nafcillin sodium | INJECTABLE;INJECTION | 061999-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | |||||
| Glaxosmithkline | NALLPEN | nafcillin sodium | INJECTABLE;INJECTION | 062755-001 | Dec 19, 1986 | DISCN | No | No | 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 Glaxosmithkline
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline Cons | LAMISIL | terbinafine | GEL;TOPICAL | 020846-001 | Apr 29, 1998 | 5,681,849*PED | Start Trial |
| Glaxosmithkline | VALTREX | valacyclovir hydrochloride | TABLET;ORAL | 020487-002 | Jun 23, 1995 | 6,107,302*PED | Start Trial |
| Glaxosmithkline Llc | DYNACIRC CR | isradipine | TABLET, EXTENDED RELEASE;ORAL | 020336-002 | Jun 1, 1994 | 5,030,456 | Start Trial |
| Glaxosmithkline | LAMISIL | terbinafine hydrochloride | CREAM;TOPICAL | 020980-001 | Mar 9, 1999 | 4,680,291 | Start Trial |
| Glaxosmithkline | FLOVENT | fluticasone propionate | POWDER;INHALATION | 020549-002 | Nov 7, 1997 | 4,335,121*PED | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Tablets | 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg | ➤ Subscribe | 2014-02-12 |
| ➤ Subscribe | Capsules | 200 mg/38 mg | ➤ Subscribe | 2016-02-16 |
| ➤ Subscribe | Extended-release Tablets | 8 mg | ➤ Subscribe | 2008-11-03 |
| ➤ Subscribe | Capsule | 0.5 mg/0.4 mg | ➤ Subscribe | 2010-10-26 |
| ➤ Subscribe | Extended-release Tablets | 12 mg | ➤ Subscribe | 2009-02-05 |
| ➤ Subscribe | Gum | 2 mg | ➤ Subscribe | 2013-01-22 |
| ➤ Subscribe | Extended-release Tablets | 6 mg | ➤ Subscribe | 2009-07-22 |
| ➤ Subscribe | Injection | 6 mg/0.5 mL, 0.5 mL vials | ➤ Subscribe | 2004-10-25 |
| ➤ Subscribe | Orally Disintegrating Tablets | 25 mg, 50 mg, 100 mg, and 200 mg | ➤ Subscribe | 2009-12-21 |
| ➤ Subscribe | Tablets | 100 mg | ➤ Subscribe | 2007-10-31 |
| ➤ Subscribe | Tablets | 3 mg, 4 mg and 5 mg | ➤ Subscribe | 2005-02-04 |
| ➤ Subscribe | Tablets | 62.5 mg/25 mg | ➤ Subscribe | 2010-09-14 |
| ➤ Subscribe | Extended-release Capsules | 325 mg | ➤ Subscribe | 2006-11-07 |
| ➤ Subscribe | Oral Suspension | 750 mg/5 mL | ➤ Subscribe | 2009-10-20 |
| ➤ Subscribe | Capsules | 200 mg/30 mg | ➤ Subscribe | 2004-12-27 |
| ➤ Subscribe | Extended-release Tablets | 4 mg | ➤ Subscribe | 2008-10-31 |
| ➤ Subscribe | Capsules | 0.5 mg | ➤ Subscribe | 2007-10-29 |
| ➤ Subscribe | Extended-release Tablets | 3 mg | ➤ Subscribe | 2009-01-08 |
| ➤ Subscribe | Tablets | 150 mg | ➤ Subscribe | 2007-10-30 |
| ➤ Subscribe | Extended-release Tablets | 2 mg | ➤ Subscribe | 2008-10-14 |
| ➤ Subscribe | Gum | 4 mg | ➤ Subscribe | 2013-01-22 |
| ➤ Subscribe | Extended-release Tablets | 3 mg | ➤ Subscribe | 2009-01-08 |
| ➤ Subscribe | Injection | 6 mg/0.5 mL, 0.5 mL (prefilled syringes) | ➤ Subscribe | 2006-05-09 |
| ➤ Subscribe | Tablets | 0.25 mg, 0.5 mg, 1 mg and 2 mg | ➤ Subscribe | 2004-12-22 |
| ➤ Subscribe | Tablets | 250 mg/100 mg | ➤ Subscribe | 2009-04-03 |
| ➤ Subscribe | Capsules | 60 mg | ➤ Subscribe | 2010-09-08 |
| ➤ Subscribe | Extended-release Capsules | 225 mg and 425 mg | ➤ Subscribe | 2006-10-11 |
International Patents for Glaxosmithkline Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Peru | 20130042 | Start Trial |
| Portugal | 1539796 | Start Trial |
| Iceland | 2747 | Start Trial |
| South Africa | 200209369 | Start Trial |
| Brazil | PI0307319 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Glaxosmithkline Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2924034 | 1990024-0 | Sweden | Start Trial | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126 |
| 1425001 | CR 2014 00021 | Denmark | Start Trial | PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131114 |
| 2109608 | 300937 | Netherlands | Start Trial | PRODUCT NAME: NIRAPARIB, OF EEN TAUTOMEER DAARVAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET TOSYLAAT OF EEN HYDRAAT, MEER IN HET BIJZONDER HET TOSYLAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1235 20171120 |
| 1480644 | 2016C/069 | Belgium | Start Trial | PRODUCT NAME: ZAVICEFTA (COMBINAISON DE CEFTAZIDIME ET AVIBACTAM); AUTHORISATION NUMBER AND DATE: EU/1/16/1109/001 20160628 |
| 2109608 | C201830023 | Spain | Start Trial | PRODUCT NAME: NIRAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1235; DATE OF AUTHORISATION: 20171116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1235; DATE OF FIRST AUTHORISATION IN EEA: 20171116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
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