Details for Patent: 10,226,473
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Which drugs does patent 10,226,473 protect, and when does it expire?
Patent 10,226,473 protects TLANDO and is included in one NDA.
This patent has one patent family member in one country.
Summary for Patent: 10,226,473
| 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 (Plymouth, MN), Chickmath; Basawaraj (Minneapolis, 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: | 15/955,429 |
|
Patent Claim Types: see list of patent claims | Use; Composition; Dosage form; |
Drugs Protected by US Patent 10,226,473
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | 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). | ⤷ Try a Trial | ||||
| >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 10,226,473
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2012075081 | ⤷ Try a Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
