Details for Patent: 11,059,829

Which drugs does patent 11,059,829 protect, and when does it expire?

Patent 11,059,829 protects CALQUENCE and is included in one NDA.

This patent has sixty-nine patent family members in twenty-nine countries.

Summary for Patent: 11,059,829

Title:	Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide maleate
Abstract:	In some embodiments, the invention relates to crystalline solid forms, including hydrates, polymorphs, and salt forms, of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide. In some embodiments, the invention relates to amorphous solid forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide. In some embodiments, the invention also relates to pharmaceutical compositions containing the solid forms, and methods for treating conditions or disorders by administering to a subject a pharmaceutical composition that includes the forms, including pharmaceutical compositions and methods for overcoming the effects of acid reducing agents.
Inventor(s):	Blatter; Fritz (Reinach, CH), Ingallinera; Tim (San Francisco, CA), Barf; Tjeerd (Ravenstein, NL), Aret; Edwin (Almere, NL), Krejsa; Cecile (Seattle, WA), Evarts; Jerry (Bellevue, WA)
Assignee:	Acerta Pharma B.V. (Oss, NL)
Application Number:	16/863,033
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Detailed Analysis of the Scope and Claims of United States Patent 11,059,829

Overview of the Patent

United States Patent 11,059,829, titled "Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide maleate," is assigned to Acerta Pharma B.V., a subsidiary of AstraZeneca. This patent is crucial for the protection of the active ingredient in Calquence, a drug used in the treatment of certain types of blood cancers.

Inventors and Assignees

The patent was invented by a team of researchers including Fritz Blatter, Tim Ingallinera, Tjeerd Barf, Edwin Aret, Cecile Krejsa, and Jerry Evarts. The assignee is Acerta Pharma B.V., which is based in Oss, Netherlands[2][4].

Patent Issuance and Expiration

The patent was issued on July 13, 2021. It is set to expire on July 1, 2036, which is approximately 15 years from the date of issuance. This expiration date aligns with the typical 20-year term from the date of filing, adjusted for any extensions or adjustments under 35 U.S.C. 154(b)[2][4].

Scope of the Invention

The patent covers specific crystalline solid forms of the active ingredient in Calquence, including hydrates, polymorphs, and salt forms. These crystalline forms are critical for the stability, efficacy, and bioavailability of the drug. The invention relates to the chemical compound (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide maleate, which is a BTK (Bruton's tyrosine kinase) inhibitor used in the treatment of conditions such as mantle cell lymphoma and chronic lymphocytic leukemia[2][4].

Claims

The patent includes multiple claims that protect various aspects of the invention:

• Claim 1: This claim covers the specific crystalline solid form of the compound, including its hydrates, polymorphs, and salt forms.
• Claim 2-5: These claims detail the methods of preparing these crystalline forms.
• Claim 6-10: These claims cover the pharmaceutical compositions containing these crystalline forms and their use in treating diseases associated with BTK activity[4].

Patent Landscape

The patent landscape for Calquence and its active ingredient is complex, with multiple patents protecting different aspects of the drug:

• Related Patents: Other patents, such as US9290504 and US10272083, also protect various formulations and uses of BTK inhibitors. These patents expire at different dates, with some expiring as early as November 2026 and others in July 2032 and July 2036[1][2].
• Exclusivity: The FDA has granted exclusivity periods for Calquence, which run concurrently with the patent terms. Currently, there is no generic version of Calquence approved in the United States[2].

Impact on Generic Availability

The expiration of these patents will significantly impact the availability of generic versions of Calquence. Until the patents expire, AstraZeneca retains exclusive rights to manufacture and market the drug. The earliest patent expiration date relevant to Calquence is November 24, 2026, but the key patent protecting the specific crystalline form of the active ingredient expires on July 1, 2036[1][2].

Competitive Landscape

The protection afforded by these patents ensures that AstraZeneca maintains a competitive edge in the market for BTK inhibitors. Other pharmaceutical companies cannot launch therapeutically equivalent versions of Calquence until these patents expire. This exclusivity period allows AstraZeneca to recoup its investment in research and development and to maintain market share[1][2].

Conclusion

United States Patent 11,059,829 is a critical component of the intellectual property portfolio protecting Calquence. It ensures that AstraZeneca retains exclusive rights to the specific crystalline forms of the drug's active ingredient until July 1, 2036. This patent, along with other related patents, forms a robust barrier to entry for generic competitors, allowing AstraZeneca to maintain its market position in the treatment of blood cancers.

Key Takeaways

• Patent Expiration: The patent expires on July 1, 2036.
• Scope: Covers specific crystalline solid forms of the active ingredient in Calquence.
• Claims: Protects the compound, its preparation methods, and pharmaceutical compositions.
• Impact on Generics: No generic version can be launched until the patent expires.
• Competitive Edge: Ensures AstraZeneca's market exclusivity for the drug.

FAQs

Q: What is the main subject of United States Patent 11,059,829? A: The patent covers the crystalline solid forms of the active ingredient in Calquence, a BTK inhibitor.

Q: Who are the inventors of this patent? A: The inventors include Fritz Blatter, Tim Ingallinera, Tjeerd Barf, Edwin Aret, Cecile Krejsa, and Jerry Evarts.

Q: When does the patent expire? A: The patent expires on July 1, 2036.

Q: What is the impact of this patent on generic versions of Calquence? A: The patent prevents the launch of generic versions of Calquence until its expiration.

Q: Who is the assignee of this patent? A: The assignee is Acerta Pharma B.V., a subsidiary of AstraZeneca.

Cited Sources

1. Pharsight: Calquence patent expiration - Pharsight
2. Drugs.com: Generic Calquence Availability - Drugs.com
3. Google Patents: United States Patent 11,059,829 - googleapis.com
4. Unified Patents: US-11059829 - Unified Patents

Drugs Protected by US Patent 11,059,829

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	11,059,829		Y	Y		TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED MANTLE CELL LYMPHOMA WHO ARE INELIGIBLE FOR AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION IN COMBINATION WITH BENDAMUSTINE AND RITUXIMAB
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	11,059,829		Y	Y		TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	11,059,829		Y	Y		TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	11,059,829		Y	Y		TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	11,059,829		Y	Y		TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	11,059,829		Y	Y		TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	11,059,829		Y	Y		TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA

International Family Members for US Patent 11,059,829

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016286548
Australia	2020277123
Australia	2022291635
Canada	2991096
Chile	2017003445
China	108349978
China	113480542