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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 |
| Patent Litigation for Glaxosmithkline Llc: | See patent lawsuits for Glaxosmithkline Llc |
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 | LANOXICAPS | digoxin | CAPSULE;ORAL | 018118-002 | Jul 26, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-006 | Apr 10, 2009 | AB | RX | Yes | No | 7,927,624 | ➤ Sign Up | Y | ➤ Sign Up | ||
| Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-001 | May 8, 2009 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ||||
| Glaxosmithkline Llc | LANOXICAPS | digoxin | CAPSULE;ORAL | 018118-003 | Jul 26, 1982 | DISCN | No | 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 | LANOXICAPS | digoxin | CAPSULE;ORAL | 018118-002 | Jul 26, 1982 | 4,088,750 | ➤ Sign Up |
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-006 | Apr 10, 2009 | 5,422,123 | ➤ Sign Up |
| Glaxosmithkline Llc | AMERGE | naratriptan hydrochloride | TABLET;ORAL | 020763-001 | Feb 10, 1998 | 4,997,841 | ➤ Sign Up |
| Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, CHEWABLE;ORAL | 020764-001 | Aug 24, 1998 | 5,698,226*PED | ➤ 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
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1109119 | ➤ Sign Up |
| Argentina | 038417 | ➤ Sign Up |
| Australia | 2003260336 | ➤ Sign Up |
| European Patent Office | 1272167 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Glaxosmithkline Llc Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0443983/03 | Switzerland | ➤ Sign Up | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 |
| C/GB02/037 | United Kingdom | ➤ Sign Up | PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419 |
| C0009 | Belgium | ➤ Sign Up | PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015 |
| 2011 00026 | Denmark | ➤ Sign Up | PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216 |
| 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.
