DrugPatentWatch Database Preview
Assertio Company Profile
Email this page to a colleague
» See Plans and PricingWhat is the competitive landscape for ASSERTIO, and when can generic versions of ASSERTIO drugs launch?
ASSERTIO has four approved drugs.
There are twenty-one US patents protecting ASSERTIO drugs.
There are one hundred and eighty patent family members on ASSERTIO drugs in forty countries and eleven supplementary protection certificates in nine countries.
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 |
International Patents for Assertio Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 0113897 | Start Trial |
| Czech Republic | 2002129 | Start Trial |
| Germany | 4426245 | Start Trial |
| South Africa | 9506118 | Start Trial |
| Australia | 2005256512 | Start Trial |
| Hungary | 9502146 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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.
Here is a list of applicants with similar names.
