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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Moodys
Harvard Business School
Medtronic
McKinsey

Last Updated: January 18, 2020

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Assertio Company Profile

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Summary for Assertio
International Patents:180
US Patents:21
Tradenames:4
Ingredients:3
NDAs:4
Patent Litigation for Assertio: See patent lawsuits for Assertio

Drugs and US Patents for Assertio

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Assertio GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 BX RX Yes Yes 7,731,989   Start Trial Y   Start Trial
Assertio GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 BX RX Yes Yes 8,192,756   Start Trial Y   Start Trial
Assertio GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 BX RX Yes Yes 8,333,992   Start Trial Y   Start Trial
Assertio NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794-001 Oct 15, 2012 DISCN Yes No 7,994,364   Start Trial Y 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 Assertio

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 6,287,594   Start Trial
Assertio NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794-001 Oct 15, 2012 6,071,970   Start Trial
Assertio GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 6,340,475   Start Trial
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 6,365,180   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ASSERTIO drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Potassium Oral Solution (Sachet) 50 mg ➤ Subscribe 2011-01-24
➤ Subscribe Oral Solution 20 mg/mL ➤ Subscribe 2013-12-30
➤ Subscribe Tablets 300 mg and 600 mg ➤ Subscribe 2011-10-31
➤ Subscribe Capsules 25 mg ➤ Subscribe 2012-11-14
➤ Subscribe Tablets x50 mg, 75 mg, and 100 mg ➤ Subscribe 2012-11-20
➤ Subscribe Oral Solution 20 mg/mL ➤ Subscribe 2013-12-20

Supplementary Protection Certificates for Assertio Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0693475 1190004-0.L Sweden   Start Trial PRODUCT NAME: TAPENTADOL; NAT. REG. NO/DATE: 42622-42628 20100910; FIRST REG.: DE 7543-7548,7661-76270" EESGODKLANDKOD="DE" EESGODKDATUM="2010-08-19" SEGODKNR="42622-42628 20100819
0693475 PA2011007 Lithuania   Start Trial PRODUCT NAME: TAPENTADOLUM; NAT. REGISTRATION NO/DATE: LT/1/10/2341/001 - LT/1/10/2341/66, 2011 02 19; LT/1/10/2342/001 - LT/1/10/2342/110 20110219; FIRST REGISTRATION: 75043.00.00 - 75048.00.00, 2010 08 19; 76261.00.00 - 76270.00.00 20100819
0693475 CA 2010 00036 Denmark   Start Trial
0693475 C00693475/01 Switzerland   Start Trial PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
>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:

McKinsey
Colorcon
Johnson and Johnson
Moodys
Express Scripts
McKesson

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