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SELZENTRY Drug Profile
» See Plans and Pricing
When do Selzentry patents expire, and what generic alternatives are available?
Selzentry is a drug marketed by Viiv Hlthcare and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has ninety-six patent family members in fifty-five countries.
The generic ingredient in SELZENTRY is maraviroc. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the maraviroc profile page.
US ANDA Litigation and Generic Entry Outlook for Selzentry
Selzentry was eligible for patent challenges on August 6, 2011.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 25, 2022. This may change due to patent challenges or generic licensing.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
There are two tentative approvals for the generic drug (maraviroc), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for SELZENTRY
| International Patents: | 96 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 74 |
| Clinical Trials: | 20 |
| Patent Applications: | 2,565 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SELZENTRY |
| DailyMed Link: | SELZENTRY at DailyMed |
Generic Entry Opportunity Date for SELZENTRY
Generic Entry Dates for SELZENTRY*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;ORAL |
Generic Entry Dates for SELZENTRY*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for SELZENTRY
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hospital Universitario Infanta Leonor | Phase 2 |
| Hospital Clínic de Barcelona | Phase 2 |
| ViiV Healthcare | Phase 2 |
Pharmacology for SELZENTRY
| Drug Class | CCR5 Co-receptor Antagonist |
| Mechanism of Action | Chemokine Co-receptor 5 Antagonists |
US Patents and Regulatory Information for SELZENTRY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | SELZENTRY | maraviroc | SOLUTION;ORAL | 208984-001 | Nov 4, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-004 | Nov 4, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-003 | Nov 4, 2016 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-001 | Aug 6, 2007 | RX | Yes | No | Start Trial | 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 SELZENTRY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | SELZENTRY | maraviroc | SOLUTION;ORAL | 208984-001 | Nov 4, 2016 | Start Trial | Start Trial |
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-004 | Nov 4, 2016 | Start Trial | Start Trial |
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-002 | Aug 6, 2007 | Start Trial | Start Trial |
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-003 | Nov 4, 2016 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SELZENTRY
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Morocco | 26715 | Start Trial |
| Estonia | 200100344 | Start Trial |
| Panama | 8487701 | Start Trial |
| Slovenia | 1140085 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SELZENTRY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1284974 | 122008000011 | Germany | Start Trial | PRODUCT NAME: 4,4-DIFLUORO-N-((1S)-3-((1R,3S,5S)-3-(3-METHYL-5-(PROPAN-2-YL)-4H-1,2,4-TRIAZOL-4-YL)-8-AZABICYCLO(3.2.1)OCTAN-8-YL)-1-PHENYLPROPYL)CYCLOHEXANECARBOXAMIDE; REGISTRATION NO/DATE: EU/1/07/418/001-010 20070918 |
| 1284974 | PA2008004,C1284974 | Lithuania | Start Trial | PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010, 0070918 |
| 1284974 | 91417 | Luxembourg | Start Trial | 91417, EXPIRES: 20220918 |
| 1284974 | SPC/GB08/014 | United Kingdom | Start Trial | PRODUCT NAME: MARAVIROC, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/07/418/001 20070918; UK EU/1/04/418/002 20070918; UK EU/1/04/418/003 20070918; UK EU/1/04/418/004 20070918; UK EU/1/04/418/005 20070918; UK EU/1/04/418/006 20070918; UK EU/1/04/418/007 20070918; UK EU/1/04/418/008 20070918; UK EU/1/04/418/009 20070918; UK EU/1/04/418/010 20070918 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
