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Last Updated: March 19, 2024

Glaxosmithkline Company Profile


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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 Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-006 Jun 21, 2011 AB RX Yes No 8,637,512 ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-007 Jan 27, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-001 Sep 19, 1997 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc RYTHMOL propafenone hydrochloride TABLET;ORAL 019151-001 Nov 27, 1989 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline BACTOCILL oxacillin sodium INJECTABLE;INJECTION 061334-007 Mar 26, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline FLOVENT fluticasone propionate POWDER;INHALATION 020549-002 Nov 7, 1997 DISCN No 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 Glaxosmithkline

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline VENTOLIN albuterol sulfate TABLET;ORAL 019112-001 Jul 10, 1986 3,644,353 ⤷  Try a Trial
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-002 Dec 30, 1985 4,057,323 ⤷  Try a Trial
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-003 Jun 1, 1995 5,863,559*PED ⤷  Try a Trial
Glaxosmithkline RELENZA zanamivir POWDER;INHALATION 021036-001 Jul 26, 1999 4,811,731 ⤷  Try a Trial
Glaxosmithkline Llc RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021416-002 Sep 4, 2003 5,681,588 ⤷  Try a Trial
Glaxosmithkline VENTOLIN ROTACAPS albuterol sulfate CAPSULE;INHALATION 019489-001 May 4, 1988 3,644,353 ⤷  Try a Trial
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-003 Oct 4, 1996 5,427,798 ⤷  Try a 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 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
➤ 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

Supplementary Protection Certificates for Glaxosmithkline Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1425001 C20140013 00103 Estonia ⤷  Try a Trial PRODUCT NAME: VILANTEROOLTRIFENATAAT;REG NO/DATE: K(2013)8089 (LOPLIK) 13.11.2013
1740177 300694 Netherlands ⤷  Try a Trial PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140430
1480644 2016C/069 Belgium ⤷  Try a Trial PRODUCT NAME: ZAVICEFTA (COMBINAISON DE CEFTAZIDIME ET AVIBACTAM); AUTHORISATION NUMBER AND DATE: EU/1/16/1109/001 20160628
2316456 300918 Netherlands ⤷  Try a Trial PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
2109608 1890020-9 Sweden ⤷  Try a Trial PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE; REG. NO/DATE: EU/1/17/1235 20171120
2316456 CR 2017 00062 Denmark ⤷  Try a Trial PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330
0809498 10C0038 France ⤷  Try a Trial PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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