Details for Patent: 11,311,554
Which drugs does patent 11,311,554 protect, and when does it expire?
Patent 11,311,554 protects AZMIRO and is included in one NDA.
Summary for Patent: 11,311,554
| Title: | Pharmaceutical compositions of testosterone |
| Abstract: | The present invention provides stable pharmaceutical compositions, comprising a pharmaceutically effective amount of testosterone or a pharmaceutically acceptable ester thereof, a pharmaceutically acceptable oil vehicle, and a stabilizing amount of benzyl alcohol, for example, about 1% to 3% weight/volume of benzyl alcohol. The present invention also provides a process for stabilizing testosterone-containing pharmaceutical compositions by ageing them at a temperature of about 20° C. to about 60° C. for at least 48 hours, e.g., prior to secondary packing and labeling. These compositions were stable over the shelf life of the product, without exhibiting crystal formation, even upon storing at temperatures of about 2° C. to about 8° C. Other aspects of the invention relate to methods for making such pharmaceutical compositions, and methods of using such pharmaceutical compositions for hormone replacement therapy, e.g., in a male patient having a condition associated with symptoms of deficiency or absence of endogenous testosterone. |
| Inventor(s): | Umangi K. SONI, Prem Prakash SINGH, Hanimi Reddy BAPATU, Praveen Kumar Subbappa, Ajay Kumar Singh |
| Assignee: | Azurity Pharmaceuticals Inc |
| Application Number: | US16/363,376 |
|
Patent Claim Types: see list of patent claims | Use; Composition; |
Drugs Protected by US Patent 11,311,554
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Azurity | AZMIRO | testosterone cypionate | SOLUTION;INTRAMUSCULAR | 216318-001 | Jun 2, 2022 | DISCN | 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. | >Patented / Exclusive Use | >Submissiondate |
Foreign Priority and PCT Information for Patent: 11,311,554
| Foriegn Application Priority Data | ||
| Foreign Country | Foreign Patent Number | Foreign Patent Date |
| India | 201841012805 | Apr 4, 2018 |
