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Generated: July 25, 2017
What is the competitive landscape for GLAXOSMITHKLINE LLC, and what generic alternatives to GLAXOSMITHKLINE LLC drugs are available?
GLAXOSMITHKLINE LLC has fifteen approved drugs.| Patents: | 8 |
| Tradenames: | 14 |
| Ingredients: | 9 |
| NDAs: | 15 |
| Drug Master File Entries: (click here to view) | 15 |
| 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 | ropinirole hydrochloride | TABLET;ORAL | 020658-002 | Sep 19, 1997 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-002 | May 8, 2009 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-005 | Oct 31, 2008 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-001 | Jun 13, 2008 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Glaxosmithkline Llc | RYTHMOL SR | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021416-003 | Sep 4, 2003 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxosmithkline Llc | LANOXICAPS | digoxin | CAPSULE;ORAL | 018118-004 | Sep 24, 1984 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444-001 | Sep 20, 1995 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-005 | Sep 19, 1997 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, CHEWABLE;ORAL | 020764-004 | Sep 8, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | LANOXICAPS | digoxin | CAPSULE;ORAL | 018118-001 | Jul 26, 1982 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
lamotrigine | Extended-release Tablets | 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg | LAMICTAL XR | 2/12/2014 |
lamotrigine | Orally Disintegrating Tablets | 25 mg, 50 mg, 100 mg, and 200 mg | LAMICTAL ODT | 12/21/2009 |
atovaquone | Oral Suspension | 750 mg/5 mL | MEPRON | 10/20/2009 |
ropinirole hydrochloride | Extended-release Tablets | 6 mg | REQUIP XL | 7/22/2009 |
ropinirole hydrochloride | Extended-release Tablets | 12 mg | REQUIP XL | 2/5/2009 |
ropinirole hydrochloride* | Extended-release Tablets | 3 mg | REQUIP XL | 1/8/2009 |
ropinirole hydrochloride | Extended-release Tablets | 3 mg | REQUIP XL | 1/8/2009 |
ropinirole hydrochloride | Extended-release Tablets | 8 mg | REQUIP XL | 11/3/2008 |
ropinirole hydrochloride | Extended-release Tablets | 4 mg | REQUIP XL | 10/31/2008 |
ropinirole hydrochloride | Extended-release Tablets | 2 mg | REQUIP XL | 10/14/2008 |
propafenone | Extended-release Capsules | 325 mg | RYTHMOL SR | 11/7/2006 |
propafenone hydrochloride | Extended-release Capsules | 225 mg and 425 mg | RYTHMOL SR | 10/11/2006 |
ropinirole hydrochloride | Tablets | 3 mg, 4 mg and 5 mg | REQUIP | 2/4/2005 |
ropinirole hydrochloride | Tablets | 0.25 mg, 0.5 mg, 1 mg and 2 mg | REQUIP | 12/22/2004 |
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 | ► Subscribe | |||||||||||||||||||||||||||
| 8,460,706 | Hydrophilic/lipophilic polymeric matrix dosage formulation | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Germany | 60134964 | ► Subscribe | |||||||||||||||||||||||||||
| Argentina | 068185 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | 200911267 | ► Subscribe | |||||||||||||||||||||||||||
| Malaysia | 139719 | ► Subscribe | |||||||||||||||||||||||||||
| Malaysia | 141049 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0036 | Belgium | ► Subscribe | PRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702 | ||||||||||||||||||||||||||
| 2011 00026 | Denmark | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 0443983/03 | Switzerland | ► Subscribe | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 | ||||||||||||||||||||||||||
| C/GB96/040 | United Kingdom | ► Subscribe | PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702 | ||||||||||||||||||||||||||
| C0009 | Belgium | ► Subscribe | PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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