Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
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Moodys
Boehringer Ingelheim
AstraZeneca

Last Updated: December 11, 2019

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PF PRISM CV Company Profile

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Summary for PF PRISM CV
International Patents:1002
US Patents:44
Tradenames:13
Ingredients:12
NDAs:17

Drugs and US Patents for PF PRISM CV

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-003 Dec 30, 2004 AB RX Yes No 6,197,819*PED   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin SOLUTION;ORAL 022488-001 Jan 4, 2010 AA RX Yes Yes   Start Trial   Start Trial
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No 6,410,550*PED   Start Trial Y   Start Trial
Pf Prism Cv PRISTIQ desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 021992-001 Feb 29, 2008 AB RX Yes Yes   Start Trial   Start Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No   Start Trial   Start Trial
Pf Prism Cv LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-002 Oct 11, 2017 RX Yes No 10,022,447*PED   Start Trial Y   Start Trial
Pf Prism Cv ZMAX azithromycin FOR SUSPENSION, EXTENDED RELEASE;ORAL 050797-001 Jun 10, 2005 DISCN Yes No 6,984,403   Start Trial Y   Start Trial
>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 PF PRISM CV

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-003 Dec 30, 2004 5,563,175   Start Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 5,212,155*PED   Start Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-004 Jan 25, 2010 5,403,833*PED   Start Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 6,002,008   Start Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002 5,212,155*PED   Start Trial
Pf Prism Cv VFEND voriconazole TABLET;ORAL 021266-001 May 24, 2002 5,364,938   Start Trial
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 RE44768*PED   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for PF PRISM CV drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 25 mg/mL, 1.8 mL vial ➤ Subscribe 2011-05-25
➤ Subscribe Tablets 0.5 mg ➤ Subscribe 2010-08-25
➤ Subscribe Extended-release Tablets 82.5 mg and 165 mg ➤ Subscribe 2018-02-02
➤ Subscribe Extended-release Tablets 82.5 mg and 165 mg ➤ Subscribe 2018-02-02
➤ Subscribe Extended-release Tablets 25 mg ➤ Subscribe 2015-05-08
➤ Subscribe Tablets 400 mg ➤ Subscribe 2018-10-15
➤ Subscribe Oral Solution 20 mg/mL ➤ Subscribe 2010-05-19
➤ Subscribe Tablets 1 mg and 5 mg ➤ Subscribe 2018-02-23
➤ Subscribe Tablets 50 mg and 200 mg ➤ Subscribe 2008-04-14
➤ Subscribe For Injection 50 mg per vial ➤ Subscribe 2009-06-15
➤ Subscribe Tablets 1 mg and 2 mg ➤ Subscribe 2009-12-17
➤ Subscribe Extended-release Tablets 330 mg ➤ Subscribe 2018-01-29
➤ Subscribe Extended-release Tablets 330 mg ➤ Subscribe 2018-01-29
➤ Subscribe Extended-release Tablets 50 mg and 100 mg ➤ Subscribe 2012-02-29
➤ Subscribe Tablets 100mg and 500mg ➤ Subscribe 2016-09-06
➤ Subscribe Capsules 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg ➤ Subscribe 2008-12-30
➤ Subscribe Tablets 0.5 mg and 1 mg ➤ Subscribe 2010-05-10
➤ Subscribe For Injection 200 mg/vial ➤ Subscribe 2008-09-12
➤ Subscribe Tablets 5 mg ➤ Subscribe 2016-11-07
➤ Subscribe Oral Suspension 40 mg/mL ➤ Subscribe 2010-10-08

Supplementary Protection Certificates for PF PRISM CV Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0641330 27/2004 Austria   Start Trial PRODUCT NAME: PREGABALIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/04/279/001 - EU/1/04/279/025 20040706
1666481 C201730033 Spain   Start Trial PRODUCT NAME: TOFACITINIB Y SALES FARMACEUTICAMENTE ACEPTABLES DEL MISMO, INCLUYENDO LA SAL CITRATO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1178; DATE OF AUTHORISATION: 20170322; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1178; DATE OF FIRST AUTHORISATION IN EEA: 20170322
0536515 06C0031 France   Start Trial PRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 20060424
1218348 438 Finland   Start Trial
0440372 SPC/GB02/031 United Kingdom   Start Trial PRODUCT NAME: VORICONAZOLE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/02/212/001-025 20020319
1218348 2013C/015 Belgium   Start Trial PRODUCT NAME: AXITINIB; AUTHORISATION NUMBER AND DATE: EU/1/12/777/001 20120905
1786785 CA 2013 00009 Denmark   Start Trial
>Patent Number >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.

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Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
McKinsey
Merck
Boehringer Ingelheim
Mallinckrodt

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.