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 forty-nine approved drugs.
There are thirty-two US patents protecting GLAXOSMITHKLINE drugs.
There are seven hundred and twenty-four patent family members on GLAXOSMITHKLINE drugs in fifty-nine countries and one hundred and eighty-five supplementary protection certificates in twenty countries.
Summary for GLAXOSMITHKLINE
International Patents: | 724 |
US Patents: | 32 |
Tradenames: | 104 |
Ingredients: | 90 |
NDAs: | 149 |
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 | JESDUVROQ | daprodustat | TABLET;ORAL | 216951-003 | Feb 1, 2023 | RX | Yes | No | 11,117,871 | ⤷ Try a Trial | Y | 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 | |||
Glaxosmithkline | TRELEGY ELLIPTA | fluticasone furoate; umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 209482-001 | Sep 18, 2017 | RX | Yes | Yes | 7,439,393*PED | ⤷ Try a Trial | Y | ⤷ 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 | |||||
>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 | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-001 | Aug 20, 2014 | 5,873,360 | ⤷ Try a Trial |
Glaxosmithkline | NIX | permethrin | LOTION;TOPICAL | 019435-001 | Mar 31, 1986 | 4,024,163 | ⤷ Try a Trial |
Glaxosmithkline | MALARONE PEDIATRIC | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-002 | Jul 14, 2000 | 5,998,449*PED | ⤷ Try a Trial |
Glaxosmithkline | WELLBUTRIN | bupropion hydrochloride | TABLET;ORAL | 018644-003 | Dec 30, 1985 | 3,885,046 | ⤷ 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 | 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 |
➤ 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 |
International Patents for GLAXOSMITHKLINE Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Argentina | 100818 | ⤷ Try a Trial |
China | 102935230 | ⤷ Try a Trial |
Norway | 20060928 | ⤷ Try a Trial |
Japan | 4426845 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for GLAXOSMITHKLINE Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0303507 | 97C0102 | Belgium | ⤷ Try a Trial | PRODUCT NAME: NARATRIPTAN HYDROCHLORIDUM; REGISTRATION NO/DATE: 725 IS 278 F 3 19970818; 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 | 132018000000341 | Italy | ⤷ Try a Trial | PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117 |
1740177 | C 2014 041 | Romania | ⤷ Try a Trial | PRODUCT NAME: BROMURADE UMECLIDINIUM4-[HIDROXI(DIFENIL)METIL]-1-{2-[(FENILMETIL)OXI]ETIL}-1-AZONIABI DATE OF NATIONAL AUTHORISATION: 20140428; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (CICLO[2.2.2]OCTAN; NATIONAL AUTHORISATION NUMBER: EU/1/14/922/001, EU/1/14/922/002, EU/1/14/922/003;EEA): EU/1/14/922/001, EU/1/14/922/002, EU/1/14/922/003; DATE OF FIRST AUTHORISATION IN EEA: 20140428 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.