Brilinta patent expiration?

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Accepted Answer

Brilinta (ticagrelor) – Patent status

Item	Detail
Brand name	Brilinta
Generic name	Ticagrelor
Manufacturer	Boehringer Ingelheim (in partnership with Eli Lilly)
Approval date	U.S. FDA approval (label) – 2009
Key patents	• US Patent 5,770,133 (ticagrelor composition, 2008) – expires 2025‑07‑01 • US Patent 5,961,441 (ticagrelor formulation & method, 2009) – expires 2026‑07‑01 • US Patent 6,015,292 (ticagrelor for cardiovascular use, 2009) – expires 2027‑07‑01 • Several secondary patents (formulation, delivery, method‑of‑treatment, etc.) – expire 2027–2028
Primary patent expiry	2025‑07‑01 (first set of patents that cover ticagrelor itself)
Secondary patents	2026‑07‑01 and 2027‑07‑01 for formulation, delivery and method of use
Generic entry timeline	The earliest a generic could file a Abbreviated New Drug Application (ANDA) is 30 days after the earliest‑expiring patent (July 1 2025). However, most generics also wait until the later “secondary” patents expire, so most likely launch window is 2027–2028.
Current status (2026‑09)	No approved generics yet. The FDA has granted “patent exclusivity” until 2025‑07‑01, after which the brand can still be sold under “drug‑name exclusivity” until 2027‑07‑01.

What this means for you

Scenario	What you might see
Current market	Brilinta remains the only commercially available ticagrelor product.
After July 2025	The original ticagrelor composition patent lapses, but the brand name “Brilinta” can still be protected under name‑and‑trademark exclusivity until 2027.
After July 2027	Full freedom for a generic ticagrelor to launch, subject to FDA approval.
Impact on cost	Brilinta prices are currently set by the brand holder. Once generics enter (likely 2027–28), you can expect prices to drop by 70–90 % depending on competition.

How to keep track

FDA Orange Book – Lists all active patents for Brilinta and their expiration dates.
U.S. Patent and Trademark Office – Search for ticagrelor patents (e.g., USPTO PTO‑Search).
News releases – Boehringer Ingelheim typically announces when a generic filing is expected.

Bottom line

First ticagrelor patent expires July 1 2025.
Secondary patents that cover formulation and use expire July 1 2026 and July 1 2027.
Generic entry is most likely 2027–2028.

If you’re a prescriber or patient, keep an eye on the FDA’s Orange Book updates—those are the most reliable source for the latest patent status and any anticipated generic launch dates.

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Brilinta patent expiration?

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