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Last Updated: December 26, 2024

GLAXOSMITHKLINE Company Profile


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Summary for GLAXOSMITHKLINE
International Patents:716
US Patents:32
Tradenames:104
Ingredients:90
NDAs:149
Drug Master File Entries: 8
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 TOTACILLIN ampicillin/ampicillin trihydrate FOR SUSPENSION;ORAL 060666-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 RX Yes Yes 7,498,440 ⤷  Subscribe Y Y ⤷  Subscribe
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-003 Jun 13, 2008 DISCN Yes No ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline TIMENTIN clavulanate potassium; ticarcillin disodium INJECTABLE;INJECTION 050590-002 Apr 1, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe
>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 IMITREX sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-001 Dec 28, 1992 5,037,845*PED ⤷  Subscribe
Glaxosmithkline TRITEC ranitidine bismuth citrate TABLET;ORAL 020559-001 Aug 8, 1996 5,008,256 ⤷  Subscribe
Glaxosmithkline SEREVENT salmeterol xinafoate POWDER;INHALATION 020692-001 Sep 19, 1997 4,992,474*PED ⤷  Subscribe
Glaxosmithkline TAGAMET cimetidine hydrochloride INJECTABLE;INJECTION 017939-002 Approved Prior to Jan 1, 1982 3,950,333 ⤷  Subscribe
>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 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

Supplementary Protection Certificates for GLAXOSMITHKLINE Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0817637 05C0022 France ⤷  Subscribe PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
2109608 C20180013 00262 Estonia ⤷  Subscribe PRODUCT NAME: NIRAPARIIB;REG NO/DATE: EU/1/17/1235 20.11.2017
2109608 CA 2018 00017 Denmark ⤷  Subscribe PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE; REG. NO/DATE: EU/1/17/1235 20171120
0299602 SPC/GB96/040 United Kingdom ⤷  Subscribe PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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