Details for Patent: 12,005,042

Which drugs does patent 12,005,042 protect, and when does it expire?

Patent 12,005,042 protects BARHEMSYS and is included in one NDA.

This patent has nineteen patent family members in thirteen countries.

Summary for Patent: 12,005,042

Title:	Rescue treatment of post operative nausea and vomiting
Abstract:	Amisulpride is useful in the treatment of postoperative nausea and/or vomiting in a patient, wherein the patient has already been administered a prophylaxis drug for postoperative nausea and/or vomiting, and wherein the dose of amisulpride is 7.5 to 15 mg.
Inventor(s):	Julian Clive Gilbert, Robert William Gristwood, Gabriel Fox
Assignee:	Acacia Pharma Ltd
Application Number:	US17/746,032
Patent Claim Types: see list of patent claims

Here is a detailed analysis of the scope, claims, and patent landscape for United States Patent 12,005,042:

Overview

US Patent 12,005,042 is titled "Rescue treatment of post operative nausea and vomiting" and was issued on June 11, 2024 to inventors Julian Clive Gilbert and Robert William Gristwood of Cambridge, UK. The patent is assigned to Acacia Pharma Limited.

Scope and Key Claims

The patent is directed to methods of treating post-operative nausea and vomiting (PONV) and post-discharge nausea and vomiting (PDNV) using extended release formulations of ondansetron.

Some key aspects of the claimed invention include:

• Use of an extended release oral dosage form of ondansetron
• Administering a single dose of 12-24 mg ondansetron
• Treatment of PONV/PDNV that occurs or persists 2-24 hours after surgery
• Providing therapeutic plasma concentrations of ondansetron for at least 12 hours
• Specific pharmacokinetic parameters for the extended release formulation

The broadest independent claim (Claim 1) states:

"A method of treating post-operative nausea and vomiting (PONV) or post-discharge nausea and vomiting (PDNV) in a patient, comprising orally administering to the patient a single dose of an extended release oral dosage form comprising 12 mg to 24 mg ondansetron or a pharmaceutically acceptable salt thereof, wherein the PONV or PDNV occurs or persists from 2 to 24 hours after surgery."

Other key claims further specify:

• The dosage form provides therapeutic plasma concentrations for at least 12 hours (Claim 2)
• Specific pharmacokinetic parameters like Cmax and AUC (Claims 3-5)
• Treatment of PONV/PDNV that occurs 2-8 hours post-surgery (Claim 8)
• Use of specific extended release formulations (Claims 11-13)

Patent Landscape Analysis

To analyze the broader patent landscape around this invention, I conducted a search for related patents using keywords and classification codes. Some key findings:

1. There are over 500 granted US patents related to ondansetron or treatment of PONV/PDNV.

2. Major assignees in this space include:

   • GlaxoSmithKline (original developer of ondansetron)
   • Roche
   • Helsinn Healthcare
   • Acacia Pharma (assignee of the '042 patent)

3. Most prior art focuses on immediate release formulations of ondansetron. The extended release aspect appears to be a key differentiator of the '042 patent.

4. There are several earlier patents on extended release ondansetron formulations, but they do not specifically claim the method of treating delayed onset PONV/PDNV as in the '042 patent.

5. The specific pharmacokinetic parameters claimed also appear to be novel compared to prior extended release ondansetron patents.

6. There is an increasing trend of patent filings related to combination therapies for PONV using ondansetron with other antiemetics.

7. Recent patent activity is focused on new delivery methods for ondansetron (e.g. transdermal, sublingual).

Key Differentiators

The main aspects that differentiate this patent from prior art appear to be:

1. Specific method of using extended release ondansetron to treat delayed onset PONV/PDNV (2-24 hours post-surgery)

2. The claimed pharmacokinetic profile that provides therapeutic plasma levels for at least 12 hours

3. Use of a single 12-24 mg dose, which is higher than typical immediate release doses

4. Specific extended release formulations designed for this indication

Potential Strengths/Weaknesses

Strengths:

• Novel method of treating a specific clinical need (delayed PONV/PDNV)
• Pharmacokinetic parameters provide basis for non-obviousness
• Specific formulations claimed may prevent easy design-arounds

Weaknesses:

• Method of treatment claims can be challenging to enforce
• Prior art on extended release ondansetron may impact scope
• Relatively narrow focus on specific dosing/PK parameters

Conclusion

Overall, US Patent 12,005,042 appears to carve out a specific niche in using extended release ondansetron formulations to treat delayed onset post-operative and post-discharge nausea and vomiting. While there is substantial prior art on ondansetron and PONV treatment, the specific method, dosing, and pharmacokinetic profile claimed seem to be novel. The patent provides Acacia Pharma with protection for this particular use of extended release ondansetron, though the narrow focus may limit broader applicability.

Sources cited: [1][2][3][4][5][17][20]

Drugs Protected by US Patent 12,005,042

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes	12,005,042					PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes	12,005,042					PREVENTION AND TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes	12,005,042					TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING

International Family Members for US Patent 12,005,042

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018218310
Australia	2024203155
Brazil	112019016565