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Details for Patent: 5,767,251

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Patent 5,767,251 protects OVIDREL, FOLLISTIM, FOLLISTIM AQ, GONAL-F, GONAL-F RFF, GONAL-F RFF REDI-JECT, and LUVERIS, and is included in eight NDAs.

This patent has sixty patent family members in eleven countries.

Summary for Patent: 5,767,251

Title: Recombinant heterodimeric human fertility hormones, and methods, cells, and vectors and DNA for the production thereof
Abstract:Biologically active heterodimeric human fertility hormones composed of two different subunits, each subunit being synthesized in the same cell transformed by at least one cell expression vector having heterologous DNA encoding each subunit with each subunit being controlled by a separate promoter. Preferred human fertility hormones include hCG, hLH and hFSH.
Inventor(s): Reddy; Vermuri B. (Westboro, MA), Hsiung; Nancy (Wellesley, MA), Beck; Anton K. (Grisbeladierbeg, CH), Bernstine; Edward George (Boston, MA)
Assignee: Genzyme Corporation (Cambridge, MA)
Application Number:08/008,233
Patent Claim Types:
see list of patent claims
Patent PDF download available with subscription

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Emd Serono
choriogonadotropin alfa
INJECTABLE;INJECTION021149-001Sep 20, 2000DISCNNo5,767,251<disabled>
Organon Usa Inc
follitropin alfa/beta
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020582-001Sep 29, 1997DISCNNo5,767,251<disabled>
Organon Usa Inc
follitropin alfa/beta
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020582-002Sep 29, 1997DISCNNo5,767,251<disabled>
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Non-Orange Book Patents for Patent: 5,767,251

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
4,840,896 Heteropolymeric protein<disabled in preview>
5,639,640 DNA encoding the beta subunit of human follide stimulating hormone and expression vectors and cells containing same<disabled in preview>
6,455,282 Cells, vectors and methods for producing biologically active TSH<disabled in preview>
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International Patent Family for Patent: 5,767,251

Country Document Number Publication Date Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office0160091Nov 06, 1985
JapanH0832244Mar 29, 1996
Denmark172625Mar 15, 1999
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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