Glaxosmithkline Company Profile
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What is the competitive landscape for GLAXOSMITHKLINE
GLAXOSMITHKLINE has one hundred and fifty-one approved drugs.
There are thirty-six US patents protecting GLAXOSMITHKLINE drugs.
There are seven hundred and sixty-eight patent family members on GLAXOSMITHKLINE drugs in sixty-two countries and one hundred and eighty-four supplementary protection certificates in twenty-one countries.
Summary for Glaxosmithkline
| International Patents: | 768 |
| US Patents: | 36 |
| Tradenames: | 106 |
| Ingredients: | 92 |
| NDAs: | 151 |
| 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 Llc | LAMICTAL CD | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 020764-001 | Aug 24, 1998 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ||||
| Glaxosmithkline | COMPAZINE | prochlorperazine | SUPPOSITORY;RECTAL | 011127-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | |||||
| Glaxosmithkline | ZEJULA | niraparib tosylate | TABLET;ORAL | 214876-001 | Apr 26, 2023 | RX | Yes | No | 8,071,579 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-004 | Jun 13, 2008 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | |||||
| Glaxosmithkline | IMITREX STATDOSE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 020080-002 | Feb 1, 2006 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ||||
| Glaxosmithkline | SEREVENT | salmeterol xinafoate | AEROSOL, METERED;INHALATION | 020236-001 | Feb 4, 1994 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | |||||
| Glaxosmithkline | LORATADINE | loratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 075822-001 | Feb 10, 2003 | 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 | WELLBUTRIN | bupropion hydrochloride | TABLET;ORAL | 018644-003 | Dec 30, 1985 | 3,885,046 | ⤷ Start Trial |
| Glaxosmithkline | TAGAMET | cimetidine | TABLET;ORAL | 017920-004 | Dec 14, 1983 | 3,950,333 | ⤷ Start Trial |
| Glaxosmithkline | TAGAMET | cimetidine | TABLET;ORAL | 017920-004 | Dec 14, 1983 | 4,024,271 | ⤷ Start Trial |
| Glaxosmithkline | WELLBUTRIN | bupropion hydrochloride | TABLET;ORAL | 018644-002 | Dec 30, 1985 | 4,435,449 | ⤷ Start Trial |
| Glaxosmithkline | AGENERASE | amprenavir | CAPSULE;ORAL | 021007-001 | Apr 15, 1999 | 5,585,397 | ⤷ Start Trial |
| Glaxosmithkline | TAGAMET | cimetidine | TABLET;ORAL | 017920-005 | Apr 30, 1986 | 3,950,333 | ⤷ Start Trial |
| Glaxosmithkline | TRITEC | ranitidine bismuth citrate | TABLET;ORAL | 020559-001 | Aug 8, 1996 | 5,629,297 | ⤷ 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 | 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 |
| ➤ 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 |
International Patents for Glaxosmithkline Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 338959 | ⤷ Start Trial |
| World Intellectual Property Organization (WIPO) | 2019052133 | ⤷ Start Trial |
| Spain | 2822773 | ⤷ Start Trial |
| Japan | 7682923 | ⤷ Start Trial |
| Canada | 2533332 | ⤷ Start Trial |
| Eurasian Patent Organization | 202090573 | ⤷ Start Trial |
| Spain | 2557930 | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Glaxosmithkline Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2317997 | 2190050-1 | Sweden | ⤷ Start Trial | PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212 |
| 0526543 | SPC/GB99/030 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: ZANAMIVIR, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR DERIVATIVE; REGISTERED: SE 14997 19990209; UK PL10949/0327 19990625 |
| 0257344 | SPC/GB98/043 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: DIPYRIDAMOLE, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT, AND O-ACETYLSALICYLIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY SALT, I.E. ASASANTIN RETARD; REGISTERED: FR NL 22160 19970709; UK 00015/0224 19980512 |
| 0984957 | 1290006-4 | Sweden | ⤷ Start Trial | PRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812 |
| 2109608 | 18/2018 | Austria | ⤷ Start Trial | PRODUCT NAME: NIRAPARIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, STEREOISOMER ODER TAUTOMER DAVON, INSBESONDERE DAS TOSYLAT ODER EIN HYDRAT, INSBESONDERE DAS TOSYLAT-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1235 (MITTEILUNG) 20171120 |
| 2506844 | 394 50009-2018 | Slovakia | ⤷ Start Trial | PRODUCT NAME: FLUTIKAZONFUROAT / UMEKLIDINIUM / VILANTEROL VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1236/001 - EU/1/17/1236/003 20171117 |
| 1633724 | PA2015016 | Lithuania | ⤷ Start Trial | PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
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