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:

Johnson and Johnson
Dow
Express Scripts
Colorcon
Boehringer Ingelheim
McKesson

Last Updated: November 18, 2019

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Pfizer Company Profile

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Summary for Pfizer

Drugs and US Patents for Pfizer

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer RENESE polythiazide TABLET;ORAL 012845-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial
Pfizer NAVANE thiothixene hydrochloride INJECTABLE;INJECTION 016904-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial
Pfizer TROVAN PRESERVATIVE FREE alatrofloxacin mesylate INJECTABLE;INJECTION 020760-001 Dec 18, 1997 DISCN No No   Start Trial   Start Trial
Pfizer NAVANE thiothixene CAPSULE;ORAL 016584-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial
Pfizer CAVERJECT alprostadil INJECTABLE;INJECTION 020755-001 Oct 31, 1997 DISCN No No   Start Trial   Start Trial
Pfizer Inc IBRANCE palbociclib CAPSULE;ORAL 207103-001 Feb 3, 2015 RX Yes No   Start Trial   Start Trial
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes 9,937,181   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 Pfizer

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-003 Jan 29, 1990 4,404,216*PED   Start Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 6,685,967   Start Trial
Pfizer MINIZIDE polythiazide; prazosin hydrochloride CAPSULE;ORAL 017986-003 Approved Prior to Jan 1, 1982 4,130,647   Start Trial
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-004 Jan 30, 2004 5,969,156*PED   Start Trial
Pfizer GLUCOTROL XL glipizide TABLET, EXTENDED RELEASE;ORAL 020329-002 Apr 26, 1994 4,612,008   Start Trial
Pfizer GLUCOTROL XL glipizide TABLET, EXTENDED RELEASE;ORAL 020329-001 Apr 26, 1994 4,612,008   Start Trial
Pfizer Inc VIAGRA sildenafil citrate TABLET;ORAL 020895-002 Mar 27, 1998 5,250,534*PED   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for PFIZER drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe For Injection 500 mg/vial ➤ Subscribe 2011-06-17
➤ Subscribe Extended-release Tablets 4 mg and 8 mg ➤ Subscribe 2012-10-31
➤ Subscribe Tablets 5 mg/80 mg ➤ Subscribe 2009-04-07
➤ Subscribe Capsules 75 mg, 100 mg and 125 mg ➤ Subscribe 2019-02-04
➤ Subscribe Extended-release Tablets 11 mg ➤ Subscribe 2016-11-07
➤ Subscribe Tablets 100 mg ➤ Subscribe 2004-10-25
➤ Subscribe Capsules 200 mg/30 mg ➤ Subscribe 2004-12-27
➤ Subscribe Sublingual Tablets 0.3 mg, 0.4 mg and 0.6 mg ➤ Subscribe 2005-10-19
➤ Subscribe Capsules 20 mg, 40 mg, 60 mg and 80 mg ➤ Subscribe 2005-02-07
➤ Subscribe Capsules 0.125 mg, 0.25 mg, and 0.5 mg ➤ Subscribe 2014-05-01
➤ Subscribe Tablets 150 mg and 200 mg ➤ Subscribe 2005-11-09
➤ Subscribe Tablets 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/10 mg, 10 mg/20 mg and 10 mg/80 mg ➤ Subscribe 2006-12-29
➤ Subscribe Tablets 2.5 mg/40 mg ➤ Subscribe 2009-09-17
➤ Subscribe Injection 20 mg/mL, 2 mL and 5 mL vials ➤ Subscribe 2004-07-26
➤ Subscribe Tablets 25 mg and 50 mg ➤ Subscribe 2004-11-19
➤ Subscribe Tablets 20 mg and 40 mg ➤ Subscribe 2010-03-29
➤ Subscribe Capsules 200 mg/38 mg ➤ Subscribe 2016-02-16
➤ Subscribe Sublingual Tablets 0.6 mg ➤ Subscribe 2011-12-29
➤ Subscribe Capsules 5 mg and 10 mg ➤ Subscribe 2005-06-21
Premature patent expirations for PFIZER

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
  Start Trial   Start Trial

Supplementary Protection Certificates for Pfizer Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 2013/034 Ireland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC; NAT REGISTRATION NO/DATE: EU/1/12/807-001, 004, 005, 007-009, 012, 013 015 20130121
1746976 300885 Netherlands   Start Trial PRODUCT NAME: ONIVYDE - IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
0413455 98C0040 Belgium   Start Trial PRODUCT NAME: ALATROFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/060/001 19980327; FIRST REGISTRATION: CH 54484 19980327
0678503 C300499 Netherlands   Start Trial PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
0383472 SPC/GB96/036 United Kingdom   Start Trial PRODUCT NAME: INSULIN LISPRO, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY-ACCEPTABLE SALT; REGISTERED: CH 53290 19951123; CH 53553 19951123; UK EU/1/96/007/001 19960430; UK EU/1/96/007/002 19960430; UK EU/1/96/007/003 19960430
0705275 SPC/GB00/027 United Kingdom   Start Trial PRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801
2209800 C02209800/01 Switzerland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
>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:

Johnson and Johnson
Colorcon
McKinsey
Harvard Business School
AstraZeneca
Boehringer Ingelheim

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