US 11013729

Here's a concise summary of US Patent 11013729:

US Patent 11013729: Oral pharmaceutical compositions of dabigatran etexilate

• Title: Oral pharmaceutical compositions of dabigatran etexilate
• Current Assignee: Breckenridge Pharmaceutical Inc (Note: The listed assignees may be inaccurate, as Google has not performed a legal analysis and makes no representation as to the accuracy of the list.)
• Original Assignee: Towa Pharmaceutical Europe SL
• Inventors: Pratibha S. Pilgaonkar, Maharukh T. Rustomjee, Anilkumar S. Gandhi
• Filing Date: 2013-02-21
• Issue Date: 2021-05-25

Abstract:
The patent describes compositions that include a mixture of at least two types of particles. The first type of particles contains dabigatran etexilate (as the free base or a pharmaceutically acceptable salt, polymorph, solvate, or hydrate). The second type of particles contains at least one pharmaceutically acceptable organic acid. These compositions are intended for use in reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and/or preventing venous thromboembolic events in adult patients who have undergone elective total hip or knee replacement surgery. The patent also covers processes for preparing these compositions.

Plain-Language Overview of Independent Claims:

• Claim 1: This claim covers a pharmaceutical composition containing at least two distinct types of particles. The first type of particles contains dabigatran etexilate (or its salt/polymorph forms) and is free from any organic or inorganic acids. The second type of particles contains at least one pharmaceutically acceptable organic acid, is coated with a protective layer, and does not contain dabigatran etexilate.

• Claim 11: This claim describes a pharmaceutical composition that consists of a mixture of two distinct types of particles and at least one pharmaceutically acceptable excipient. Similar to Claim 1, the first particle type contains dabigatran etexilate (or its salt/polymorph forms) and is free from organic and inorganic acids. The second particle type contains at least one pharmaceutically acceptable organic acid, is coated with a protective layer, and is free from dabigatran etexilate.

• Claim 16: This claim covers a capsule that contains a pharmaceutical composition. This composition consists of a mixture of two distinct types of particles and at least one pharmaceutically acceptable excipient. As in the previous claims, the first particle type contains dabigatran etexilate (or its salt/polymorph forms) and is free from organic and inorganic acids. The second particle type contains at least one pharmaceutically acceptable organic acid, is coated with a protective layer, and is free from dabigatran etexilate.

Litigation Information:
According to the patent information, the patent family has litigation, including a PTAB case IPR2025-01107 which was filed but "Not Instituted - Procedural," and a US case filed in the Delaware District Court. As of April 26, 2026, no specific dockets for US Patent 11013729 were found in the CAFC 2026 dockets.