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Last Updated: March 28, 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 VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-002 Jun 23, 1995 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline BACTOCILL oxacillin sodium INJECTABLE;INJECTION 062736-002 Dec 19, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 RX Yes Yes 9,750,726 ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-003 Apr 26, 2023 RX Yes Yes 11,091,459 ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline AMOXIL amoxicillin CAPSULE;ORAL 050459-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-002 Aug 20, 2014 RX Yes Yes 8,746,242*PED ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-003 Apr 26, 2023 RX Yes Yes 8,436,185 ⤷  Try a Trial Y ⤷  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

Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ 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

Supplementary Protection Certificates for Glaxosmithkline Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1740177 2014/057 Ireland ⤷  Try a Trial PRODUCT NAME: UMECLIDINIUM BROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
1305329 SPC/GB08/026 United Kingdom ⤷  Try a Trial PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116
0817637 05C0022 France ⤷  Try a Trial PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
2506844 SPC/GB18/020 United Kingdom ⤷  Try a Trial PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
0257344 20/1999 Austria ⤷  Try a Trial PRODUCT NAME: DIPYRIDAMOL IN KOMBINATION MIT ACETYLSALICYLSAEURE; NAT. REGISTRATION NO/DATE: 1-22779 19981112; FIRST REGISTRATION: FR NL 22160 19970709
1740177 300694 Netherlands ⤷  Try a Trial PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140430
1633724 15C0022 France ⤷  Try a Trial PRODUCT NAME: OLAPARIB,SELS ET SOLVATES DE CELUI-CI; REGISTRATION NO/DATE: EU 1/14/959 20141218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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