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Federal Trade Commission
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Generated: December 10, 2018

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Synthon Pharms Company Profile

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What is the competitive landscape for SYNTHON PHARMS, and when can generic versions of SYNTHON PHARMS drugs launch?

SYNTHON PHARMS has twelve approved drugs.

There is one US patent protecting SYNTHON PHARMS drugs. There are four tentative approvals on SYNTHON PHARMS drugs.

There are four patent family members on SYNTHON PHARMS drugs in four countries and thirty-four supplementary protection certificates in ten countries.

Summary for Synthon Pharms
International Patents:4
US Patents:1
Tradenames:10
Ingredients:10
NDAs:12

Drugs and US Patents for Synthon Pharms

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Synthon Pharms BICALUTAMIDE bicalutamide TABLET;ORAL 077973-001 Jul 6, 2009 DISCN No No ➤ Sign Up ➤ Sign Up
Synthon Pharms RISPERIDONE risperidone TABLET;ORAL 078187-001 Oct 22, 2009 DISCN No No ➤ Sign Up ➤ Sign Up
Synthon Pharms SIMVASTATIN simvastatin TABLET, ORALLY DISINTEGRATING;ORAL 021961-002 Oct 9, 2007 DISCN No No ➤ Sign Up ➤ Sign Up
Synthon Pharms SIMVASTATIN simvastatin TABLET, ORALLY DISINTEGRATING;ORAL 021961-001 Oct 9, 2007 DISCN No No ➤ Sign Up ➤ Sign Up
Synthon Pharms LETROZOLE letrozole TABLET;ORAL 090196-001 Jun 3, 2011 DISCN No No ➤ Sign Up ➤ Sign Up
Synthon Pharms FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075899-003 Jan 17, 2001 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

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Premature patent expirations for SYNTHON PHARMS

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
➤ Sign Up ➤ Sign Up

Supplementary Protection Certificates for Synthon Pharms Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00625 Netherlands ➤ Sign Up PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
/2005 Austria ➤ Sign Up PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402
C/GB11/010 United Kingdom ➤ Sign Up PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
0625 Netherlands ➤ Sign Up PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
2004000026 Germany ➤ Sign Up PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402
00478 Netherlands ➤ Sign Up PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
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Here is a list of applicants with similar names.

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Teva
McKinsey
QuintilesIMS
Citi
Johnson and Johnson
Colorcon
Fuji

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