TICAGRELOR Drug Patent Profile
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Which patents cover Ticagrelor, and what generic alternatives are available?
Ticagrelor is a drug marketed by Alkem Labs Ltd, Amneal, Hisun Pharm Hangzhou, Mylan, Sigmapharm Labs Llc, Sunshine, and Watson Labs Inc. and is included in seven NDAs.
The generic ingredient in TICAGRELOR is ticagrelor. There are twenty-one drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ticagrelor
A generic version of TICAGRELOR was approved as ticagrelor by HISUN PHARM HANGZHOU on January 23rd, 2019.
Summary for TICAGRELOR
Recent Clinical Trials for TICAGRELOR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Gianluca Di Bella | Phase 3 |
| Antonio Micari | Phase 3 |
| Greca Zanda | Phase 3 |
Pharmacology for TICAGRELOR
| Drug Class | P2Y12 Platelet Inhibitor |
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors P2Y12 Receptor Antagonists Phenylalanine Hydroxylase Activators |
| Physiological Effect | Decreased Platelet Aggregation |
Anatomical Therapeutic Chemical (ATC) Classes for TICAGRELOR
Paragraph IV (Patent) Challenges for TICAGRELOR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BRILINTA | Tablets | ticagrelor | 60 mg | 022433 | 3 | 2015-09-30 |
| BRILINTA | Tablets | ticagrelor | 90 mg | 022433 | 16 | 2015-07-20 |
US Patents and Regulatory Information for TICAGRELOR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alkem Labs Ltd | TICAGRELOR | ticagrelor | TABLET;ORAL | 208567-001 | Apr 21, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sunshine | TICAGRELOR | ticagrelor | TABLET;ORAL | 208508-001 | Apr 6, 2020 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan | TICAGRELOR | ticagrelor | TABLET;ORAL | 208597-001 | Jul 9, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Watson Labs Inc | TICAGRELOR | ticagrelor | TABLET;ORAL | 208390-001 | Sep 4, 2018 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal | TICAGRELOR | ticagrelor | TABLET;ORAL | 208531-001 | Jan 23, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for TICAGRELOR
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| AstraZeneca AB | Brilique | ticagrelor | EMEA/H/C/001241 Brilique, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients withacute coronary syndromes (ACS) ora history of myocardial infarction (MI) and a high risk of developing an atherothrombotic eventBrilique, co-administered with acetyl salicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with a history of myocardial infarction (MI occurred at least one year ago) and a high risk of developing an atherothrombotic event. |
Authorised | no | no | no | 2010-12-03 | |
| AstraZeneca AB | Possia | ticagrelor | EMEA/H/C/002303 Possia, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non-ST-elevation myocardial infarction [NSTEMI] or ST-elevation myocardial infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG). |
Withdrawn | no | no | no | 2010-12-03 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
