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Glaxosmithkline Company Profile
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-seven 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: | 857 |
| 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 | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-002 | Aug 20, 2014 | RX | Yes | Yes | 7,101,866 | See Pricing | Y | Y | See Pricing | ||
| Glaxosmithkline | VONTROL | diphenidol hydrochloride | TABLET;ORAL | 016033-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | See Pricing | See Pricing | |||||
| Glaxosmithkline | ANTEPAR | piperazine citrate | SYRUP;ORAL | 009102-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | See Pricing | See Pricing | |||||
| >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 Cons | LAMISIL AT | terbinafine hydrochloride | SOLUTION;TOPICAL | 021124-001 | Mar 17, 2000 | 6,121,314*PED | See Pricing |
| Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-002 | Aug 26, 1997 | 5,554,639*PED | See Pricing |
| Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, CHEWABLE;ORAL | 020764-004 | Sep 8, 2000 | 4,602,017*PED | See Pricing |
| >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 | 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 |
| ➤ 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 |
International Patents for Glaxosmithkline Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Austria | 453421 | See Pricing |
| New Zealand | 600026 | See Pricing |
| Austria | 263721 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Glaxosmithkline Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1740177 | 208 50012-2014 | Slovakia | See Pricing | PRODUCT NAME: UMEKLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001 - EU/1/14/922/003 20140430 |
| 0513917 | 98C0020 | Belgium | See Pricing | PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318 |
| 0933372 | 08C0015 | France | See Pricing | PRODUCT NAME: FOSAMPRENAVIR CALCIQUE; REG. NO/DATE: EU/1/07/282/001-002 20040712 |
| >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.
