DrugPatentWatch Database Preview
Assertio Company Profile
What is the competitive landscape for ASSERTIO, and what generic alternatives to ASSERTIO drugs are available?
ASSERTIO has four approved drugs.
There are twenty-one US patents protecting ASSERTIO drugs.
There are one hundred and seventy-nine patent family members on ASSERTIO drugs in thirty-nine countries and eleven supplementary protection certificates in nine countries.
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 |
International Patents for Assertio Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1890680 | Start Trial |
| South Korea | 20020050223 | Start Trial |
| Russian Federation | 2432160 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9936060 | Start Trial |
| Japan | 2002509103 | Start Trial |
| China | 1125221 | 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 | 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.
Here is a list of applicants with similar names.
