Details for Patent: 11,091,459

Which drugs does patent 11,091,459 protect, and when does it expire?

Patent 11,091,459 protects ZEJULA and AKEEGA and is included in three NDAs.

This patent has fifteen patent family members in thirteen countries.

Summary for Patent: 11,091,459

Title:	Niraparib compositions
Abstract:	The present invention relates to compositions comprising the compound niraparib, in particular certain solid forms of niraparib.
Inventor(s):	Wu; George (Waltham, MA), Chaber; John (Waltham, MA), McKeown; Arlene E. (Rahway, NJ), Foley; Jennifer R. (Rahway, NJ)
Assignee:	Tesaro, Inc. (Waltham, MA) Merck Sharp & Dohme Corp. (Rahway, NJ)
Application Number:	16/584,401
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Understanding the Scope and Claims of United States Patent 11,091,459: Niraparib Compositions

Introduction

United States Patent 11,091,459, titled "Niraparib compositions," is a significant patent in the field of oncology, particularly in the treatment of cancers using PARP inhibitors. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape it operates within.

Patent Overview

Issuance and Inventors

• This patent was issued on August 17, 2021, to inventors Wu George, Chaber John, McKeown Arlene E., and Foley Jennifer R.[1][2].

Scope of the Patent

Niraparib and Its Significance

• Niraparib is a poly(ADP-ribose) polymerase (PARP) inhibitor, which is crucial in the treatment of cancers, especially those with defects in homologous recombination (HR) dependent DNA double-strand break repair. This includes cancers such as ovarian, breast, and prostate cancer[1][2].

Compositions and Solid Forms

• The patent specifically relates to compositions comprising the compound niraparib, with a focus on certain solid forms of niraparib. These solid forms are designed to enhance the stability, bioavailability, and overall efficacy of the drug[1][2].

Claims of the Patent

Independent and Dependent Claims

• The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding specific limitations or features.
  • For example, an independent claim might cover the composition of niraparib in a particular solid form, while a dependent claim could specify the exact formulation, including excipients and manufacturing processes[1].

Specific Claims

• The patent claims cover various aspects of niraparib compositions, including:
  • Specific solid forms of niraparib, such as crystalline forms or amorphous forms.
  • Pharmaceutical formulations containing niraparib, including capsules, tablets, and other dosage forms.
  • Methods of preparing these compositions, which may involve specific processes to ensure stability and efficacy[1][4].

Patent Expiration Dates

• The patent is set to expire on March 27, 2038. This expiration date is critical as it determines the period during which the patent holder has exclusive rights to the invention[1][2].

Related Patents and Exclusivities

Other Niraparib Patents

• There are several other patents related to niraparib, including those covering methods of treating prostate cancer, DNA damage repair inhibitors, and specific formulations of niraparib. These patents often have overlapping but distinct claims and expiration dates[1][2].
  • For instance, Patent 11,207,311 covers methods of treating prostate cancer using niraparib and is set to expire on July 28, 2037[1].

Drug Exclusivity

• In addition to patent protection, niraparib (marketed as Zejula) also enjoys FDA-granted exclusivity. The exclusivity period for Zejula is set to expire on August 11, 2026, which provides the manufacturer with sole marketing rights during this period[2].

Broader Patent Landscape

Patent Scope and Quality

• The scope of a patent, including its claims, is a critical factor in determining its impact on innovation and competition. Narrower claims, as seen in this patent, can lead to a higher probability of grant and a shorter examination process[3].

Litigation and Enforcement

• Patents like 11,091,459 are often subject to litigation and post-grant administrative reviews. The clarity and breadth of claims can significantly affect the outcome of such proceedings[3].

Impact on Cancer Treatment

Clinical Significance

• Niraparib compositions covered under this patent have significant clinical implications. They offer targeted therapy for cancers with specific genetic deficiencies, improving treatment outcomes and patient survival rates.

  • "Inhibition of the base excision repair pathway is selectively lethal in cells which are deficient in HR dependent DNA DSB repair," highlighting the targeted mechanism of action of niraparib[2).

Conclusion

United States Patent 11,091,459 is a pivotal patent in the field of oncology, providing exclusive rights to specific compositions and formulations of niraparib. Understanding the scope, claims, and expiration dates of this patent is essential for both the pharmaceutical industry and healthcare professionals.

Key Takeaways

• Niraparib Compositions: The patent covers specific solid forms and pharmaceutical formulations of niraparib.
• Expiration Date: The patent expires on March 27, 2038.
• Related Patents: Other patents cover different aspects of niraparib use and formulation.
• Exclusivity: FDA-granted exclusivity for Zejula expires on August 11, 2026.
• Clinical Impact: Niraparib is crucial for treating cancers with HR-dependent DNA DSB repair deficiencies.

FAQs

1. What is the primary focus of United States Patent 11,091,459?

   • The primary focus is on compositions comprising the compound niraparib, particularly certain solid forms.

2. Who are the inventors of this patent?

   • The inventors are Wu George, Chaber John, McKeown Arlene E., and Foley Jennifer R.

3. What is the expiration date of this patent?

   • The patent is set to expire on March 27, 2038.

4. What other patents are related to niraparib?

   • Other patents cover methods of treating prostate cancer, DNA damage repair inhibitors, and specific formulations of niraparib.

5. What is the significance of niraparib in cancer treatment?

   • Niraparib is significant for treating cancers with defects in homologous recombination (HR) dependent DNA double-strand break repair.

Sources

1. Drugs.com - Generic Akeega Availability
2. Drugs.com - Generic Zejula Availability
3. Hoover Institution - Patent Claims and Patent Scope
4. Google Patents - Niraparib formulations

Drugs Protected by US Patent 11,091,459

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		DISCN	Yes	No	11,091,459		Y
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No	11,091,459		Y	Y
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes	11,091,459		Y	Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-001	Apr 26, 2023		RX	Yes	No	11,091,459		Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No	11,091,459		Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-003	Apr 26, 2023		RX	Yes	Yes	11,091,459		Y

International Family Members for US Patent 11,091,459

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018246214
Australia	2021245223
Brazil	112019020211
Canada	3058375
China	110944638
Eurasian Patent Organization	201992177
European Patent Office	3600314