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Glaxosmithkline Llc Company Profile
What is the competitive landscape for GLAXOSMITHKLINE LLC, and what generic alternatives to GLAXOSMITHKLINE LLC drugs are available?
There are seven US patents protecting GLAXOSMITHKLINE LLC drugs.
There are one hundred and fifty-one patent family members on GLAXOSMITHKLINE LLC drugs in forty-one countries and fourteen supplementary protection certificates in seven countries.
Summary for Glaxosmithkline Llc
| International Patents: | 151 |
| US Patents: | 7 |
| Tradenames: | 14 |
| Ingredients: | 9 |
| NDAs: | 15 |
| Drug Master File Entries: | 16 |
Drugs and US Patents for Glaxosmithkline Llc
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-002 | Jun 13, 2008 | DISCN | Yes | No | 8,303,986 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-001 | Jun 13, 2008 | AB | RX | Yes | Yes | 8,303,986 | ➤ Sign Up | Y | ➤ Sign Up | ||
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-003 | May 29, 2009 | AB | RX | Yes | No | 9,144,547 | ➤ Sign Up | Y | ➤ Sign Up | ||
| Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-002 | Dec 27, 1994 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ||||
| 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 Llc
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | RYTHMOL SR | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021416-003 | Sep 4, 2003 | 5,681,588 | ➤ Sign Up |
| Glaxosmithkline Llc | LANOXICAPS | digoxin | CAPSULE;ORAL | 018118-002 | Jul 26, 1982 | 4,088,750 | ➤ Sign Up |
| Glaxosmithkline Llc | MEPRON | atovaquone | SUSPENSION;ORAL | 020500-001 | Feb 8, 1995 | 6,649,659*PED | ➤ Sign Up |
| Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-006 | Jan 27, 1999 | 4,824,860 | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE LLC drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Capsules | 325 mg | ➤ Subscribe | 2006-11-07 |
| ➤ Subscribe | Extended-release Tablets | 4 mg | ➤ Subscribe | 2008-10-31 |
| ➤ Subscribe | Tablets | 0.25 mg, 0.5 mg, 1 mg and 2 mg | ➤ Subscribe | 2004-12-22 |
| ➤ Subscribe | Extended-release Tablets | 3 mg | ➤ Subscribe | 2009-01-08 |
| ➤ Subscribe | Extended-release Tablets | 2 mg | ➤ Subscribe | 2008-10-14 |
| ➤ Subscribe | Oral Suspension | 750 mg/5 mL | ➤ Subscribe | 2009-10-20 |
| ➤ Subscribe | Extended-release Tablets | 3 mg | ➤ Subscribe | 2009-01-08 |
| ➤ Subscribe | Extended-release Capsules | 225 mg and 425 mg | ➤ Subscribe | 2006-10-11 |
| ➤ Subscribe | Extended-release Tablets | 8 mg | ➤ Subscribe | 2008-11-03 |
| ➤ Subscribe | Tablets | 3 mg, 4 mg and 5 mg | ➤ Subscribe | 2005-02-04 |
| ➤ Subscribe | Extended-release Tablets | 12 mg | ➤ Subscribe | 2009-02-05 |
| ➤ Subscribe | Extended-release Tablets | 6 mg | ➤ Subscribe | 2009-07-22 |
| ➤ Subscribe | Orally Disintegrating Tablets | 25 mg, 50 mg, 100 mg, and 200 mg | ➤ Subscribe | 2009-12-21 |
| ➤ Subscribe | Extended-release Tablets | 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg | ➤ Subscribe | 2014-02-12 |
Non-Orange Book US Patents for Glaxosmithkline Llc
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,647,656 | Orally disintegrating tablet compositions of lamotrigine | ➤ Sign Up |
| 8,460,706 | Hydrophilic/lipophilic polymeric matrix dosage formulation | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Glaxosmithkline Llc Drugs
Supplementary Protection Certificates for Glaxosmithkline Llc Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0009 | Belgium | ➤ Sign Up | PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015 |
| 70035 | Netherlands | ➤ Sign Up | PRODUCT NAME: NARATRIPTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAA RDBAAR ZOUT OF SOLVAAT, IN HET BIJZONDER NARATRIPTAN-HYDROCHLOR IDE; NAT. REGISTRATION NO/DATE: RVG 21444 19970801; FIRST REGISTRATION: SE 13382 19970310 |
| 0443983/03 | Switzerland | ➤ Sign Up | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 |
| C/GB99/008 | United Kingdom | ➤ Sign Up | PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015 |
| 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.
