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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 sixty-five approved drugs.
There are forty-one US patents protecting GLAXOSMITHKLINE drugs.
There are eight hundred and fifty-eight patent family members on GLAXOSMITHKLINE drugs in fifty-seven countries and one hundred and forty-three supplementary protection certificates in eighteen countries.
Summary for Glaxosmithkline
| International Patents: | 858 |
| US Patents: | 41 |
| Tradenames: | 116 |
| Ingredients: | 97 |
| NDAs: | 165 |
| Drug Master File Entries: | 8 |
| Patent Litigation for Glaxosmithkline: | See patent lawsuits for Glaxosmithkline |
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 | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | RX | Yes | Yes | 7,776,895 | Start Trial | Y | Start Trial | |||
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-006 | Jun 21, 2011 | AB | RX | Yes | No | 9,144,547 | Start Trial | Y | Start Trial | ||
| Glaxosmithkline | TRELEGY ELLIPTA | fluticasone furoate; umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 209482-001 | Sep 18, 2017 | RX | Yes | Yes | 6,878,698 | Start Trial | Start Trial | ||||
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-002 | Jun 1, 1995 | AB | RX | Yes | No | Start Trial | Start Trial | ||||
| Glaxosmithkline | TICAR | ticarcillin disodium | INJECTABLE;INJECTION | 050497-005 | Apr 4, 1984 | DISCN | No | No | Start Trial | Start Trial | |||||
| Glaxosmithkline | TICAR | ticarcillin disodium | INJECTABLE;INJECTION | 050497-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | |||||
| Glaxosmithkline | BACTOCILL | oxacillin sodium | INJECTABLE;INJECTION | 061334-008 | Mar 26, 1982 | DISCN | No | No | Start Trial | Start 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 | MEPRON | atovaquone | SUSPENSION;ORAL | 020500-001 | Feb 8, 1995 | 6,649,659*PED | Start Trial |
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | 6,510,969*PED | Start Trial |
| Glaxosmithkline | WELLBUTRIN | bupropion hydrochloride | TABLET;ORAL | 018644-002 | Dec 30, 1985 | 3,885,046 | Start Trial |
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | 6,431,168*PED | Start Trial |
| Glaxosmithkline Llc | FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444-002 | Sep 20, 1995 | 4,539,333 | Start Trial |
| Glaxosmithkline | MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-001 | Jul 14, 2000 | 5,998,449*PED | Start Trial |
| Glaxosmithkline | RELENZA | zanamivir | POWDER;INHALATION | 021036-001 | Jul 26, 1999 | 4,627,432 | Start 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 | 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 |
| ➤ 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 | Capsule | 0.5 mg/0.4 mg | ➤ Subscribe | 2010-10-26 |
| ➤ 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 | 0.5 mg | ➤ Subscribe | 2007-10-29 |
| ➤ 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 |
International Patents for Glaxosmithkline Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovenia | 1775305 | Start Trial |
| Eurasian Patent Organization | 199900495 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2006109021 | Start Trial |
| Australia | 2014204459 | Start Trial |
| Hong Kong | 1145819 | Start Trial |
| Spain | 2321601 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2004012741 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Glaxosmithkline Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2924034 | CA 2019 00024 | Denmark | Start Trial | PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126 |
| 1740177 | 2014/057 | Ireland | Start Trial | PRODUCT NAME: UMECLIDINIUM BROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428 |
| 2506844 | PA2018011 | Lithuania | Start Trial | PRODUCT NAME: UMEKLIDINAS + VILANTEROLIS + FLUTIKAZONO FUROATAS; REGISTRATION NO/DATE: EU/1/17/1236 20171115 |
| 0933372 | PA2008006,C0933372 | Lithuania | Start Trial | PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712 |
| 1740177 | CR 2014 00052 | Denmark | Start Trial | PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140430 |
| 2316456 | 65/2017 | Austria | Start Trial | PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 (MITTEILUNG) 20150330 |
| 1740177 | 14C0075 | France | Start Trial | PRODUCT NAME: BROMURE D'UMECLIDINIUM; REGISTRATION NO/DATE: EU/1/14/922 001-003 20140428 |
| >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.
