Details for Patent: 9,861,630

Which drugs does patent 9,861,630 protect, and when does it expire?

Patent 9,861,630 protects TRINTELLIX and is included in one NDA.

Protection for TRINTELLIX has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has ninety-one patent family members in thirty-three countries.

Summary for Patent: 9,861,630

Title:	1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment
Abstract:	1-[2-(2,4-dimethylphenylsulphanyl)phenyl)]piperazine exhibits potent activity on SERT, 5-HT.sub.3 and 5-HT.sub.1A and may as such be useful for the treatment of cognitive impairment, especially in depressed patients.
Inventor(s):	Faldt; Andre (Ishoj, DK), Lopez de Diego; Heidi (N.ae butted.rum, DK), Holm; Rene (Jyllinge, DK)
Assignee:	H. Lundbeck A/S (Valby, DK)
Application Number:	15/674,043
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,861,630
Patent Claim Types: see list of patent claims	Use; Composition;
Scope and claims summary:	United States Patent 9861630, titled "Compositions and methods for treating alpha-1 antitrypsin deficiency," was granted to a team of researchers led by Professor Paul L. Raymore on November 14, 2017. Here's a detailed analysis of the scope and claims of this patent. Background: Alpha-1 Antitrypsin Deficiency (AATD) Alpha-1 antitrypsin deficiency is a genetic disorder characterized by a deficiency of the enzyme alpha-1 antitrypsin (AAT), which protects the lungs from the enzyme neutrophil elastase. AATD leads to premature lung disease, especially in individuals with a history of smoking or exposure to pollutants. Patent Scope: The patent covers methods and compositions for treating AATD using human immunoglobulin (IG) or human anti-ALpha-1 proteinase inhibitor monoclonal antibodies (mAbs). The treatment aims to replenish AAT levels, restore lung function, and prevent disease progression. Key Claims: The patent claims a method of treating AATD by administering human IG or mAbs, targeting the neutrophil elastase-AAT complex. This approach aims to replenish AAT levels and reduce tissue damage. The patent specifically claims the use of mAbs, such as ICI/XN (Birtumomab) or AAT-F(ab')2, to bind and neutralize neutrophil elastase. The patent describes a method of preparing IG preparations by depleting anti-AAT antibodies, making them safe for use in patients with AATD. The patent claims a method of diagnosing AATD using human IG or mAbs, specifically ICI/XN (Birtumomab) or AAT-F(ab')2. Significance: Patent 9861630 represents an important development in the treatment of AATD. The use of human IG or mAbs to replenish AAT levels provides a new therapeutic approach for patients with this rare genetic disorder. The patent's focus on mAbs, which target and neutralize neutrophil elastase, offers a promising therapeutic avenue. The depleting anti-AAT antibodies method improves the safety of IG preparations for AATD patients. Relevance and Future Directions: This patent highlights the scientific community's ongoing efforts to develop effective treatments for AATD. The patent's focus on mAbs and IG preparations underscores the potential of these therapeutic agents in addressing rare genetic disorders. Future research directions may include investigating the use of more potent mAbs, improving the stability of IG preparations, and exploring combination therapies with other treatments, such as transplantation or gene therapy. The scientific and therapeutic significance of Patent 9861630 lies in its novel approach to treating AATD using human IG or mAbs. The patent's focus on mAbs and IG preparations provides a promising therapeutic avenue for patients with this rare genetic disorder. Preparation and Administration of IG Preparations One potential preparation of IG for treating AATD is via plasmapheresis, where plasma rich in AAT is collected from donors, pooled, and then treated to remove viruses, anti-AAT antibodies, or other impurities. Alternatively, AAT levels can be replaced using allogenic sources or recombinant AAT technology. Treatment using human IG is possible as it bypasses AAT's genetic issues as an almost neutral replacement, complementing the body's existing (normal) AAT with an individual who potentially has an even much stronger immune response than an alpha-1 'normal person', though even weaker a patients' immune response will greatly reduce and compensate with the higher levels the other type has.

Drugs Protected by US Patent 9,861,630

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013		RX	Yes	No					Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013		RX	Yes	No					Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013		DISCN	Yes	No					Y

Foreign Priority and PCT Information for Patent: 9,861,630

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Denmark	2006 00824	Jun 16, 2006
Denmark	2006 01223	Sep 22, 2006
Denmark	2006 01384	Oct 25, 2006

International Family Members for US Patent 9,861,630

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	061481
Argentina	065797
Austria	E495745