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-one US patents protecting GLAXOSMITHKLINE drugs.
There are seven hundred and two 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: | 702 |
| US Patents: | 31 |
| 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 | 216951-005 | Feb 1, 2023 | RX | Yes | Yes | 11,643,397 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Glaxosmithkline | STOXIL | idoxuridine | SOLUTION/DROPS;OPHTHALMIC | 013934-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxosmithkline | TRANDATE HCT | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019174-004 | Apr 10, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxosmithkline | ZANTAC 150 | ranitidine hydrochloride | CAPSULE;ORAL | 020095-001 | Mar 8, 1994 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxosmithkline Llc | DYNACIRC CR | isradipine | TABLET, EXTENDED RELEASE;ORAL | 020336-001 | Jun 1, 1994 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxosmithkline | TOTACILLIN-N | ampicillin sodium | INJECTABLE;INJECTION | 060677-006 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxosmithkline | TAGAMET | cimetidine hydrochloride | INJECTABLE;INJECTION | 017939-002 | 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
Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ 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 |
| ➤ Subscribe | Oral Suspension | 750 mg/5 mL | ➤ Subscribe | 2009-10-20 |
International Patents for Glaxosmithkline Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | PI0619732 | ⤷ Try a Trial |
| Japan | 5746388 | ⤷ Try a Trial |
| Norway | 20065417 | ⤷ Try a Trial |
| Hungary | S1400025 | ⤷ Try a Trial |
| Australia | 2004262907 | ⤷ Try a Trial |
| Japan | 2009079056 | ⤷ Try a Trial |
| Mexico | 2016016294 | ⤷ 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 |
|---|---|---|---|---|
| 1740177 | 1490060-9 | Sweden | ⤷ Try a Trial | MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/14/922, 2014-04-30; PERIOD OF VALIDITY (FROM - UNTIL): 20250428 - 20240429 |
| 2924034 | 2019C/005 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DORAVIRINE,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAARZOUT, IN COMBINATIE MET TENOFOVIR OF EEN ESTER DAARVAN, IN HET BIJZONDER EEN DISOPROXIL ESTER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER EEN FUMARAAT ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1333/001-002 20181126 |
| 2506844 | C20180017 00244 | Estonia | ⤷ Try a Trial | PRODUCT NAME: FLUTIKASOONFUROAAT/UMEKLIDIINIUM/VILANTEROOL;REG NO/DATE: EU/1/17/1236 17.11.2017 |
| 1633724 | 1590019-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218 |
| 2109608 | SPC/GB18/016 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NIRAPARIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PARTICULARLY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE; REGISTERED: UK EU/1/17/1235 20171120; UK PLGB 19494/0294 20171120 |
| 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 |
| 2506844 | 1890025-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
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Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
