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Assertio Company Profile
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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 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 | 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 |
International Patents for Assertio Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2266539 | Start Trial |
| European Patent Office | 1294363 | Start Trial |
| Germany | 4426245 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03035177 | 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 | 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.
Here is a list of applicants with similar names.
