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 | NALLPEN | nafcillin sodium | INJECTABLE;INJECTION | 061999-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxosmithkline | IMITREX | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 020080-001 | Dec 28, 1992 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxosmithkline | VENTOLIN | albuterol sulfate | TABLET;ORAL | 019112-001 | Jul 10, 1986 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxosmithkline | TOTACILLIN | ampicillin/ampicillin trihydrate | CAPSULE;ORAL | 060060-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-003 | May 29, 2009 | AB | RX | Yes | No | 8,637,512 | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Glaxosmithkline | ANSPOR | cephradine | CAPSULE;ORAL | 061859-001 | 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 | WELLBUTRIN | bupropion hydrochloride | TABLET;ORAL | 018644-001 | Dec 30, 1985 | 3,885,046 | ⤷ Try a Trial |
| Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-007 | Jan 27, 1999 | 4,452,808 | ⤷ Try a Trial |
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-005 | Oct 31, 2008 | 5,422,123 | ⤷ Try a Trial |
| Glaxosmithkline Llc | DYNACIRC CR | isradipine | TABLET, EXTENDED RELEASE;ORAL | 020336-001 | Jun 1, 1994 | 5,030,456 | ⤷ Try a Trial |
| Glaxosmithkline | SEREVENT | salmeterol xinafoate | POWDER;INHALATION | 020692-001 | Sep 19, 1997 | 5,126,375*PED | ⤷ Try a Trial |
| Glaxosmithkline | EPIVIR-HBV | lamivudine | SOLUTION;ORAL | 021004-001 | Dec 8, 1998 | 5,532,246*PED | ⤷ 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 | 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 |
|---|---|---|
| Japan | 2019509315 | ⤷ Try a Trial |
| Poland | 3154950 | ⤷ Try a Trial |
| European Patent Office | 2506844 | ⤷ Try a Trial |
| Norway | 338398 | ⤷ Try a Trial |
| Norway | 2015008 | ⤷ Try a Trial |
| Brazil | PI0411773 | ⤷ 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 |
|---|---|---|---|---|
| 1633724 | C01633724/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016 |
| 1425001 | SPC/GB14/034 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: VILANTEROL OR SALTS OR SOLVATES THEREOF (I.E., 4-((1R)-2-((6-(2-((2,6-DICHLOROBENZYL)OXY)ETHOXY)HEXYL)AMINO)-1-HYDROXYETHYL)-2-(HYDROXYMETHYL)PHENOL OR SALTS OR SOLVATES THEREOF); REGISTERED: UK EU/1/13/886/001 20131114; UK EU/1/13/886/002 20131114; UK EU/1/13/886/003 20131114; UK EU/1/13/886/004 20131114; UK EU/1/13/886/005 20131114; UK EU/1/13/886/006 20131114 |
| 1740177 | C300694 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428 |
| 1519731 | 92269 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
| 1480644 | 1690059-9 | Sweden | ⤷ Try a Trial | PRODUCT NAME: PHARMACEUTICAL MIXTURE OR ASSOCIATION THAT INCLUDES AS ACTIVE INGREDIENTS: (1) CEFTAZIDIME OR A SALT THEREOF, AND (2) AVIBACTAM OR A SALT THEREOF; REG. NO/DATE: EU/1/16/1109 20160628 |
| 2316456 | C 2017 047 | Romania | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
