GLAXOSMITHKLINE Company Profile
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What is the competitive landscape for GLAXOSMITHKLINE, and what generic alternatives to GLAXOSMITHKLINE drugs are available?
GLAXOSMITHKLINE has one hundred and forty-nine approved drugs.
There are thirty-two US patents protecting GLAXOSMITHKLINE drugs.
There are seven hundred and sixteen patent family members on GLAXOSMITHKLINE drugs in fifty-nine countries and one hundred and eighty-eight supplementary protection certificates in twenty countries.
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 |
International Patents for GLAXOSMITHKLINE Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Brazil | 112019020211 | ⤷ Subscribe |
Lithuania | 2805945 | ⤷ Subscribe |
Canada | 2458534 | ⤷ Subscribe |
Japan | 5545690 | ⤷ Subscribe |
>Country | >Patent Number | >Estimated Expiration |
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 |
Similar Applicant Names
Here is a list of applicants with similar names.