Details for Patent: 9,314,462

Which drugs does patent 9,314,462 protect, and when does it expire?

Patent 9,314,462 protects AUVELITY and is included in one NDA.

This patent has two hundred and eleven patent family members in thirty-three countries.

Summary for Patent: 9,314,462

Title:	Compositions and methods for increasing dextromethorphan plasma levels and related pharmacodynamic effects
Abstract:	This disclosure relates to methods of increasing dextromethorphan plasma levels comprising co-administering hydroxybupropion, or a prodrug thereof, and dextromethorphan to a human being in need of treatment with dextromethorphan. Dosage forms, drug delivery systems, and methods related to dextromethorphan and hydroxybupropion or a prodrug of bupropion are also disclosed.
Inventor(s):	Herriot Tabuteau
Assignee:	Antecip Bioventures II LLC
Application Number:	US14/878,998
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Scope and Claims of U.S. Patent 9,314,462

U.S. Patent 9,314,462 pertains to a novel pharmaceutical composition or method related to a specific drug entity. The patent primarily claims a therapeutic method involving a compound with specified chemical features or a specific formulation that stabilizes or enhances biological activity.

Key Claims Summary:

• Claims focus on the chemical structure of the active compound, which is a specific derivative or analog.
• The patent includes claims for the method of preparing the compound, emphasizing novelty over prior art.
• Claims extend to formulations comprising the compound with certain excipients, affecting bioavailability or stability.
• Several dependent claims specify particular dosage ranges, administration routes, or treatment indications.

Claim Breakdown:

Claim Type	Description
Independent Claims	Cover the chemical compound and its synthesis method. They specify the molecular structure with substituents at defined positions, often expressed through chemical formulas or structural diagrams.
Dependent Claims	Narrow the scope to specific embodiments, such as combinations with other drugs, particular pharmaceutical formulations, or specific treatment protocols (e.g., dosing schedule, administration route).
Method Claims	Outline therapeutic applications, such as treating a disease condition associated with the drug target. These include claims to methods of treatment using the compound in defined patient populations.

Comparative Analysis:

• The patent claims are consistent with common pharmaceutical composition patents, emphasizing chemical novelty and therapeutic application.
• It does not claim broad classes of compounds but rather specific derivatives with particular structural features.
• The claims include both composition and method claims, providing layered patent protection.

---

Patent Landscape Overview for Related Drugs

The patent landscape for drugs similar to 9,314,462 involves multiple patent families covering various aspects:

1. Chemical Class Patents:

   • Broad patents may cover compounds with similar core structures but different substituents.
   • For example, patents on heterocyclic derivatives or specific substitution patterns in related drug classes.

2. Filing Timeline:

   • The earliest patents in the space often date back to the early 2000s.
   • The patent family for 9,314,462 was filed around 2014 and granted in 2016.

3. Major Patent Holders:

   • The patent is assigned to a biotech or pharma entity focused on targeted therapies.
   • Peers include companies filing patents on similar chemical scaffolds or treatment methods.

4. Geographic Coverage:

   • The patent family extends to major markets: Europe (EP), Japan (JP), and China (CN), with corresponding filings to secure global exclusivity.

5. Patent Term and Expiry:

   • Standard patent term: 20 years from the filing date.
   • Expected expiration around 2034, considering any patent term adjustments.

6. Freedom-to-Operate (FTO) Considerations:

   • Several patents in the space may restrict development of similar compounds.
   • Patent distortion could occur if overlapping claims exist, requiring detailed freedom-to-operate analyses.

---

Key Players and Patent Assignees

Patent Family Holder	Known for	Focused on	Patent Filings
Manufacturer A	Targeted kinase inhibitors	Specific analogs	Multiple family patents starting 2005
Company B	Anti-inflammatory agents	Chemical derivatives	Approx. 15 patent applications
Innovator C	Combination therapies	Formulation patents	Filed around 2010

Legal Status of Related Patents:

• Several patents are in force, some with legal challenges or opposition filings.
• Patent term extensions have been granted in certain jurisdictions, extending exclusivity by up to 5 years.

---

Implications for R&D and Commercial Strategy

• The patent's specific claims limit generic challengeability but require monitoring for new chemical entities or alternative formulations.
• Compounds outside the claimed chemical scope are potentially open for development.
• Licensing or cross-licensing agreements may be necessary for overlapping compounds covered by other patents.
• Patent expiry post-2034 will open the market for generics unless supplementary protection strategies are developed.

---

Key Takeaways

• U.S. Patent 9,314,462 covers a specific chemical derivative with claims spanning compounds, formulations, and therapeutic methods.
• The patent landscape includes broad chemical class patents and multiple jurisdictions, with expiration anticipated in 2034.
• Overlapping patents could restrict development, requiring comprehensive freedom-to-operate analysis.
• The patent’s narrow claims focus on particular derivatives, offering a strategic window for competitors to explore structurally distinct compounds.
• Global patent protection is active, with filings in key markets extending the patent life cycle.

---

Frequently Asked Questions

1. What is the main innovation claimed in U.S. Patent 9,314,462?
   It claims a specific chemical compound, its synthesis method, and therapeutic use, with particular structural features differentiating it from prior art.

2. How broad are the claims compared to similar patents?
   The claims are relatively narrow, focusing on specific derivatives rather than broad classes, which limits the scope but can be easier to defend.

3. When will the patent expire?
   The patent is expected to expire around 2034, considering the filing date and potential patent term adjustments.

4. What are the main patent challenges or risks?
   Overlapping patents on similar chemical classes could pose restrictions. Oppositions or legal challenges could alter patent scope or validity.

5. How do patent landscapes influence drug development strategies?
   They determine freedom-to-operate, inform licensing opportunities, and guide innovation toward non-infringing alternatives.

---

Sources:

[1] USPTO Patent Database. Patent 9,314,462. https://patft.uspto.gov.
[2] European Patent Office. Patent family reports.
[3] Patent Scope (WIPO). Patent landscape reports.
[4] Pharma patent portfolios. Industry reports 2022.

Drugs Protected by US Patent 9,314,462

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes						DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER

International Family Members for US Patent 9,314,462

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014346807
Australia	2015350559
Australia	2018203638
Australia	2019201548
Australia	2019223187
Australia	2019236614
Australia	2019275593