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Last Updated: March 29, 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 OJJAARA momelotinib dihydrochloride TABLET;ORAL 216873-003 Sep 15, 2023 RX Yes Yes 9,809,559 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline BEEPEN-VK penicillin v potassium TABLET;ORAL 062273-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline COMPAZINE prochlorperazine maleate CAPSULE, EXTENDED RELEASE;ORAL 021019-002 Oct 6, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline BACTOCILL oxacillin sodium CAPSULE;ORAL 061336-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes 8,183,257 ⤷  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 Llc LANOXICAPS digoxin CAPSULE;ORAL 018118-003 Jul 26, 1982 4,088,750 ⤷  Try a Trial
Glaxosmithkline Llc DYNACIRC CR isradipine TABLET, EXTENDED RELEASE;ORAL 020336-001 Jun 1, 1994 4,466,972 ⤷  Try a Trial
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-001 Dec 30, 1985 4,393,078 ⤷  Try a Trial
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 7,629,335 ⤷  Try a Trial
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-004 Sep 19, 1997 4,452,808 ⤷  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 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
➤ 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

Supplementary Protection Certificates for Glaxosmithkline Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0303507 64/1997 Austria ⤷  Try a Trial PRODUCT NAME: ''NARATRIPTAN'', GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER SOLVATES EINSCHLIESSLICH DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: 1-22059 19970731; FIRST REGISTRATION: SE 13382 19970310
1633724 CR 2015 00012 Denmark ⤷  Try a Trial PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216
2506844 394 50009-2018 Slovakia ⤷  Try a Trial PRODUCT NAME: FLUTIKAZONFUROAT / UMEKLIDINIUM / VILANTEROL VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1236/001 - EU/1/17/1236/003 20171117
0502314 C300095 Netherlands ⤷  Try a Trial PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
1740177 570 Finland ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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