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Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
AstraZeneca
Johnson and Johnson
Harvard Business School
Merck

Last Updated: October 19, 2019

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Assertio Company Profile

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Summary for Assertio
International Patents:179
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 022544-001 Jan 28, 2011 BX RX Yes Yes 6,723,340   Start Trial Y   Start Trial
Assertio GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 BX RX Yes Yes 8,252,332   Start Trial Y   Start Trial
Assertio GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 BX RX Yes Yes 6,488,962   Start Trial Y   Start Trial
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes 8,110,606   Start Trial   Start Trial
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 AB RX Yes Yes 8,927,604   Start Trial   Start Trial
Assertio GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 BX RX Yes Yes 8,333,992   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 Assertio

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Assertio GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 6,635,280   Start Trial
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 6,974,595   Start Trial
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 6,287,594   Start Trial
Assertio GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 6,340,475   Start Trial
Assertio GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 6,340,475   Start Trial
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 7,482,377   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 Oral Solution 20 mg/mL ➤ Subscribe 2013-12-20
➤ 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

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 SPC/GB11/031 United Kingdom   Start Trial PRODUCT NAME: TAPENTADOL IN THE FORM OF ITS BASE OR A SALT OF A PHYSIOLOGICALLY COMPATIBLE ACID, ESPECIALLY THE HYDROCHLORIDE SALT.; REGISTERED: DE 75043 20100819; UK PL 21727/0032 - 0050 20110204
0693475 PA2011007,C0693475 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 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 91793 Luxembourg   Start Trial 91793, EXPIRES: 20200712
0693475 CR 2010 00036 Denmark   Start Trial PRODUCT NAME: TAPENTADOL ((1R-2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL)-PHENOL), HERUNDER HYDROCHLORIDET; NAT. REG. NO/DATE: 45151-45158, 45162-45169 20100830; FIRST REG. NO/DATE: EU 75043.00.00-75048.00.00, 75261.00.00-75270.00.00 20100819
>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:

McKesson
Express Scripts
Harvard Business School
Dow
Merck
Johnson and Johnson

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