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 eighty-five approved drugs.
There are fifty-one US patents protecting GLAXOSMITHKLINE drugs.
There are nine hundred and eighty-five patent family members on GLAXOSMITHKLINE drugs in sixty countries and one hundred and eighty-nine supplementary protection certificates in twenty countries.
Summary for Glaxosmithkline
| International Patents: | 985 |
| US Patents: | 51 |
| Tradenames: | 134 |
| Ingredients: | 107 |
| NDAs: | 185 |
| 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 | WELLCOVORIN | leucovorin calcium | INJECTABLE;INJECTION | 087439-001 | Oct 19, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxosmithkline | THORAZINE | chlorpromazine hydrochloride | CONCENTRATE;ORAL | 009149-032 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxosmithkline | PENTACEF | ceftazidime | INJECTABLE;INJECTION | 064006-001 | Mar 31, 1992 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-001 | 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 Llc | LAMICTAL CD | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 020764-002 | Aug 24, 1998 | 4,602,017*PED | ⤷ Try a Trial |
| Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-003 | Oct 4, 1996 | 5,427,798 | ⤷ Try a Trial |
| Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | 7,361,787 | ⤷ Try a Trial |
| Glaxosmithkline | WELLBUTRIN | bupropion hydrochloride | TABLET;ORAL | 018644-001 | Dec 30, 1985 | 4,057,323 | ⤷ Try a Trial |
| Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-005 | Sep 19, 1997 | 4,452,808 | ⤷ 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 | 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 | Capsules | 200 mg/38 mg | ➤ Subscribe | 2016-02-16 |
| ➤ Subscribe | Extended-release Tablets | 12 mg | ➤ Subscribe | 2009-02-05 |
| ➤ Subscribe | Gum | 2 mg | ➤ Subscribe | 2013-01-22 |
| ➤ Subscribe | Extended-release Tablets | 6 mg | ➤ Subscribe | 2009-07-22 |
| ➤ Subscribe | Injection | 6 mg/0.5 mL, 0.5 mL vials | ➤ Subscribe | 2004-10-25 |
| ➤ Subscribe | Orally Disintegrating Tablets | 25 mg, 50 mg, 100 mg, and 200 mg | ➤ Subscribe | 2009-12-21 |
| ➤ Subscribe | Tablets | 100 mg | ➤ Subscribe | 2007-10-31 |
| ➤ Subscribe | Tablets | 3 mg, 4 mg and 5 mg | ➤ Subscribe | 2005-02-04 |
| ➤ Subscribe | Tablets | 62.5 mg/25 mg | ➤ Subscribe | 2010-09-14 |
| ➤ 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 | Capsules | 200 mg/30 mg | ➤ Subscribe | 2004-12-27 |
| ➤ Subscribe | Extended-release Tablets | 3 mg | ➤ Subscribe | 2009-01-08 |
| ➤ Subscribe | Tablets | 150 mg | ➤ Subscribe | 2007-10-30 |
| ➤ Subscribe | Extended-release Tablets | 2 mg | ➤ Subscribe | 2008-10-14 |
| ➤ Subscribe | Gum | 4 mg | ➤ Subscribe | 2013-01-22 |
| ➤ Subscribe | Extended-release Tablets | 3 mg | ➤ Subscribe | 2009-01-08 |
| ➤ Subscribe | Injection | 6 mg/0.5 mL, 0.5 mL (prefilled syringes) | ➤ Subscribe | 2006-05-09 |
| ➤ Subscribe | Tablets | 0.25 mg, 0.5 mg, 1 mg and 2 mg | ➤ Subscribe | 2004-12-22 |
| ➤ Subscribe | Tablets | 250 mg/100 mg | ➤ Subscribe | 2009-04-03 |
| ➤ Subscribe | Capsules | 60 mg | ➤ Subscribe | 2010-09-08 |
| ➤ Subscribe | Extended-release Capsules | 225 mg and 425 mg | ➤ Subscribe | 2006-10-11 |
International Patents for Glaxosmithkline Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 101411693 | ⤷ Try a Trial |
| Denmark | 1888042 | ⤷ Try a Trial |
| Spain | 2338312 | ⤷ Try a Trial |
| Norway | 2506844 | ⤷ Try a Trial |
| Croatia | P20140306 | ⤷ 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 | SPC/GB14/055 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: UMECLIDINIUM BROMIDE (ALSO REFERRED TO AS 4-(HYDROXY(DIPHENYL)METHYL)-1-(2-((PHENYLMETHYL)OXY)ETHYL)-1-AZONIABICYCLO(2.2.2)OCTANE BROMIDE); REGISTERED: UK EU/1/14/922/001 20140430; UK EU/1/14/922/002 20140430; UK EU/1/14/922/003 20140430 |
| 1425001 | PA2014019,C1425001 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VILANTEROLUM; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113 |
| 2240466 | 122018000052 | Germany | ⤷ Try a Trial | PRODUCT NAME: NIRAPARIBTOSYLAT, EINSCHLIESSLICH NIRAPARIBTOSYLATMONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1235 20171116 |
| 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 |
| >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.
