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Generated: August 18, 2017
What is the competitive landscape for GLAXO GRP LTD, and what generic alternatives to GLAXO GRP LTD drugs are available?
GLAXO GRP LTD has eight approved drugs.| Patents: | 30 |
| Tradenames: | 13 |
| Ingredients: | 4 |
| NDAs: | 8 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-003 | Jun 8, 2006 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-002 | May 14, 2004 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-001 | Jun 8, 2006 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-001 | May 10, 2013 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Glaxo Grp Ltd | ZANTAC 300 | ranitidine hydrochloride | TABLET;ORAL | 018703-002 | Dec 9, 1985 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | ADVAIR DISKUS 500/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-003 | Aug 24, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Glaxo Grp Ltd | ADVAIR DISKUS 100/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-001 | Aug 24, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Glaxo Grp Ltd | ZANTAC 300 | ranitidine hydrochloride | TABLET;ORAL | 018703-002 | Dec 9, 1985 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Glaxo Grp Ltd | FLOVENT DISKUS 100 | fluticasone propionate | POWDER;INHALATION | 020833-002 | Sep 29, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
ranitidine hydrochloride | Tablets | 150 mg | ZANTAC 150 | 10/30/2007 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,378,519 | Inhalation device | ► Subscribe | |||||||||||||||||||||||||||
| 8,198,483 | Phenethanolamine derivatives for treatment of respiratory diseases | ► Subscribe | |||||||||||||||||||||||||||
| 7,592,329 | Crystalline complexes of fluticasone-2-furoate | ► Subscribe | |||||||||||||||||||||||||||
| 7,144,845 | Compounds useful in the manufacture of an anti-inflammatory androstane derivative | ► Subscribe | |||||||||||||||||||||||||||
| 6,858,593 | Anti-inflammatory androstane derivative compositions | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United Kingdom | 0403394 | ► Subscribe | |||||||||||||||||||||||||||
| Sweden | 512934 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 03066656 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2003281751 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2031763 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2008 00022 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 1425001/02 | Switzerland | ► Subscribe | PRODUCT NAME: VILANTEROL UND FLUTICASON FUROAT; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014 | ||||||||||||||||||||||||||
| C011/2008 | Ireland | ► Subscribe | SPC011/2008: 20081105, EXPIRES: 20230110 | ||||||||||||||||||||||||||
| 2008000029 | Germany | ► Subscribe | PRODUCT NAME: FLUTICASONFUROAT UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/07/434/001-003 20080111 | ||||||||||||||||||||||||||
| C0014 | France | ► Subscribe | PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111 | ||||||||||||||||||||||||||
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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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