Details for Patent: 12,514,854
Which drugs does patent 12,514,854 protect, and when does it expire?
Patent 12,514,854 protects REZENOPY and is included in one NDA.
This patent has four patent family members in four countries.
Summary for Patent: 12,514,854
| Title: | Drug products for intranasal administration and uses thereof |
| Abstract: | Provided herein are methods of using drug products adapted for nasal delivery comprising a device and a pharmaceutical composition comprising an opioid receptor antagonist, wherein the claimed invention provides a method of treating an opioid overdose or symptom thereof in a patient in need thereof, comprising intranasally administering to the patient an aqueous pharmaceutical solution consisting of, or an aqueous pharmaceutical composition consisting essentially of: (i) naloxone hydrochloride in an amount of about 9% by weight based on the total weight of the aqueous pharmaceutical solution; (ii) glycerin in an amount of about 1.4% by weight based on the total weight of the aqueous pharmaceutical solution; (iii) a citrate buffer system adjusted by hydrochloric acid and/or sodium hydroxide; and (iv) United States Pharmacopeia (USP)—grade Purified Water; wherein the pH of the aqueous pharmaceutical solution is from about 3.5 to about 4.7; and wherein the hydrochloric acid and the sodium hydroxide may each be independently present in the aqueous pharmaceutical solution, as required, to achieve the pH from about 3.5 to about 4.7. |
| Inventor(s): | Gregory G. Plucinski, Adrian T. Raiche, Kristi R. Sims |
| Assignee: | Summit Biosciences Inc |
| Application Number: | US18/602,984 |
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Patent Claim Types: see list of patent claims | Use; Formulation; Device; |
Drugs Protected by US Patent 12,514,854
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Scienture | REZENOPY | naloxone hydrochloride | SPRAY;NASAL | 215487-001 | Apr 19, 2024 | RX | Yes | Yes | 12,514,854 | ⤷ Start Trial | TREATMENT OF OPIOID OVERDOSE | ⤷ 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 |
International Family Members for US Patent 12,514,854
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2021217164 | ⤷ Start Trial | |||
| Canada | 3166250 | ⤷ Start Trial | |||
| European Patent Office | 4100012 | ⤷ Start Trial | |||
| World Intellectual Property Organization (WIPO) | 2021158957 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
