You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Medtronic
McKinsey
Johnson and Johnson
Express Scripts

Last Updated: April 4, 2020

DrugPatentWatch Database Preview

Assertio Company Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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 ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes 7,662,858   Start Trial   Start Trial
Assertio GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 BX RX Yes Yes 8,252,332   Start Trial Y   Start Trial
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 022544-002 Jan 28, 2011 BX RX Yes Yes 8,333,992   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 NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794-001 Oct 15, 2012 DISCN Yes No RE39593   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 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 6,287,594   Start Trial
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 7,482,377   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 6,635,280   Start Trial
Assertio GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 6,340,475   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 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 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 C00693475/01 Switzerland   Start Trial PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
0693475 2011/010 Ireland   Start Trial PRODUCT NAME: TAPENTADOL IN BASIC FORM OR IN THE FORM OF A SALT OF A PHYSIOLOGICALLY COMPATIBLE ACID, ESPECIALLY TAPENTADOL HYDROCHLORIDE; NAT REGISTRATION NO/DATE: PA1189/007/001-008 20101221; FIRST REGISTRATION NO/DATE: PA1189/008/001-008 21/12/2010 GERMANY 75043.00.00 75044.00.00 75045.00.00 19/08/2010 GERMANY 76261.00.00 76262.00.00 76263.00.00 76264.00.00 76265.00.00 19/08/2010 GERMANY 75046.00.00 75047.00.00 75048.00.00 19/08/2010 GERMANY 76266.00.00 76267.00.00 76268.00.0076269.00.00 76270.00.00 20100819
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
>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.

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Colorcon
Boehringer Ingelheim
McKinsey
Dow

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 verification 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.