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Generated: July 22, 2017
What is the competitive landscape for SB PHARMCO, and what generic alternatives to SB PHARMCO drugs are available?
SB PHARMCO has three approved drugs.| Patents: | 3 |
| Tradenames: | 3 |
| Ingredients: | 3 |
| NDAs: | 3 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-005 | Aug 25, 2003 | DISCN | Yes | No | 8,236,345 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Sb Pharmco | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-003 | May 25, 1999 | AB | RX | Yes | No | 7,358,366*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-002 | Oct 10, 2002 | DISCN | Yes | No | 8,236,345 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Sb Pharmco | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-002 | May 25, 1999 | AB | RX | Yes | No | 7,358,366*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-004 | Mar 30, 2007 | DISCN | Yes | No | 7,358,366*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-001 | Oct 10, 2002 | 6,166,042*PED | ► Subscribe | ||||||||||||||||||||||
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-003 | Oct 10, 2002 | 6,166,042*PED | ► Subscribe | ||||||||||||||||||||||
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-002 | Oct 10, 2002 | 5,741,803*PED | ► Subscribe | ||||||||||||||||||||||
Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-004 | Mar 30, 2007 | 5,002,953*PED | ► Subscribe | ||||||||||||||||||||||
Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-003 | Nov 23, 2005 | 5,002,953*PED | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
glimepiride and rosiglitazone maleate | Tablets | 8 mg/2 mg and 8 mg/4 mg | AVANDARYL | 5/30/2008 |
glimepiride and rosiglitazone maleate | Tablets | 1 mg/4 mg, 2 mg/4 mg and 4 mg/4 mg | AVANDARYL | 12/22/2006 |
rosiglitazone maleate and metformin hydrochloride | Tablets | 1 mg/ 500 mg, 2 mg/ 500mg, 4 mg/ 500 mg, 2 mg/ 1000 mg and 4 mg/ 1000 mg | AVANDAMET | 10/22/2004 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,521,201 | Method for treatment of atherosclerosis | ► Subscribe | |||||||||||||||||||||||||||
| 5,646,169 | Compounds for treating eating disorders in which blood glucose levels are raised | ► Subscribe | |||||||||||||||||||||||||||
| 5,002,953 | Novel compounds | ► Subscribe | |||||||||||||||||||||||||||
| 5,756,525 | Compounds for treating eating disorders | ► Subscribe | |||||||||||||||||||||||||||
| 5,232,925 | Compounds | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| New Zealand | 518946 | ► Subscribe | |||||||||||||||||||||||||||
| Slovakia | 286985 | ► Subscribe | |||||||||||||||||||||||||||
| Hong Kong | 1049788 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1939303 | ► Subscribe | |||||||||||||||||||||||||||
| Croatia | P20020416 | ► 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.
Export unavailable in trial.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5006-2008 | Slovakia | ► Subscribe | PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408 | ||||||||||||||||||||||||||
| 1261586/02 | Switzerland | ► Subscribe | PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329 | ||||||||||||||||||||||||||
| C/GB01/002 | United Kingdom | ► Subscribe | PRODUCT NAME: 5-(4-(2-(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY) BENZYL)-2,4-THIAZOLIDINEDIONE, "ROSIGLITAZONE" ITS TAUTOMERS, PHARMACEUTICALLY ACCEPTABLE SALTS, SUCH AS THE MALEATE, AND PHARMACEUTICALLY ACCEPTABLE SOLVATES.; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711 | ||||||||||||||||||||||||||
| /2012 | Austria | ► Subscribe | PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124 | ||||||||||||||||||||||||||
| 9 5017-2014 | Slovakia | ► Subscribe | PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116 | ||||||||||||||||||||||||||
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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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