Details for Patent: 9,943,527

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Which drugs does patent 9,943,527 protect, and when does it expire?

Patent 9,943,527 protects TLANDO and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 9,943,527

Patent landscape, scope, and claims:

Title:	High-strength testosterone undecanoate compositions
Abstract:	The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone C.sub.max to serum testosterone C.sub.ave of about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration C.sub.ave range for a male subject is provided.
Inventor(s):	Giliyar; Chandrashekar (North Maple Grove, MN), Chickmath; Basawaraj (Plymouth, MN), Chidambaram; Nachiappan (Sandy, UT), Patel; Mahesh V. (Salt Lake City, UT), Venkateshwaran; Srinivansan (Salt Lake City, UT)
Assignee:	Lipocine Inc. (Salt Lake City, UT)
Application Number:	15/594,508
Patent Claim Types: see list of patent claims	Use; Composition;
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Drugs Protected by US Patent 9,943,527

Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	9,943,527	⤷ Subscribe				TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

International Family Members for US Patent 9,943,527

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Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2012075081	⤷ Subscribe
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

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