GLEEVEC Drug Patent Profile
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When do Gleevec patents expire, and when can generic versions of Gleevec launch?
Gleevec is a drug marketed by Novartis and is included in two NDAs.
The generic ingredient in GLEEVEC is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Gleevec
A generic version of GLEEVEC was approved as imatinib mesylate by SUN PHARM on December 3rd, 2015.
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Questions you can ask:
- What is the 5 year forecast for GLEEVEC?
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Summary for GLEEVEC
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 151 |
Clinical Trials: | 235 |
Patent Applications: | 3,903 |
Drug Prices: | Drug price information for GLEEVEC |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GLEEVEC |
What excipients (inactive ingredients) are in GLEEVEC? | GLEEVEC excipients list |
DailyMed Link: | GLEEVEC at DailyMed |
![GLEEVEC drug patent expirations Drug patent expirations by year for GLEEVEC](/p/graph/s/t/GLEEVEC-patent-expirations.png)
![Drug Prices for GLEEVEC](/p/graph/drug-price/GLEEVEC.png)
Recent Clinical Trials for GLEEVEC
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Reema A. Patel | Phase 2 |
H. Jean Khoury Cure CML Consortium | Phase 2 |
Research Institute for Gastroenterology and Liver Diseases (RIGLD) | Phase 1/Phase 2 |
Pharmacology for GLEEVEC
Drug Class | Kinase Inhibitor |
Mechanism of Action | Bcr-Abl Tyrosine Kinase Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors |
Paragraph IV (Patent) Challenges for GLEEVEC
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
GLEEVEC | Tablets | imatinib mesylate | 100 mg and 400 mg | 021588 | 1 | 2007-03-12 |
US Patents and Regulatory Information for GLEEVEC
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | GLEEVEC | imatinib mesylate | CAPSULE;ORAL | 021335-001 | May 10, 2001 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | GLEEVEC | imatinib mesylate | TABLET;ORAL | 021588-002 | Apr 18, 2003 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novartis | GLEEVEC | imatinib mesylate | CAPSULE;ORAL | 021335-002 | May 10, 2001 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | GLEEVEC | imatinib mesylate | TABLET;ORAL | 021588-001 | Apr 18, 2003 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for GLEEVEC
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | GLEEVEC | imatinib mesylate | TABLET;ORAL | 021588-001 | Apr 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | GLEEVEC | imatinib mesylate | CAPSULE;ORAL | 021335-001 | May 10, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | GLEEVEC | imatinib mesylate | TABLET;ORAL | 021588-001 | Apr 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | GLEEVEC | imatinib mesylate | CAPSULE;ORAL | 021335-001 | May 10, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | GLEEVEC | imatinib mesylate | TABLET;ORAL | 021588-002 | Apr 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | GLEEVEC | imatinib mesylate | TABLET;ORAL | 021588-002 | Apr 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GLEEVEC
See the table below for patents covering GLEEVEC around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 0998473 | ⤷ Sign Up | |
Hungary | 230185 | Crystal modification of a n-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use | ⤷ Sign Up |
Hong Kong | 1028599 | ⤷ Sign Up | |
Slovenia | 0998473 | ⤷ Sign Up | |
South Africa | 9302397 | ⤷ Sign Up | |
Israel | 155029 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GLEEVEC
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0564409 | 2002/005 | Ireland | ⤷ Sign Up | PRODUCT NAME: IMATINIB OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; NAT REGISTRATION NO/DATE: EU/1/01/198/001-006 20011107; FIRST REGISTRATION NO/DATE: CH 55807 55807 01 55807 02 20010621; PAEDIATRIC INVESTIGATION PLAN: P/0028/2012 |
0564409 | SPC005/2002 | Ireland | ⤷ Sign Up | SPC005/2002: 20051123, EXPIRES: 20160620 |
0564409 | C00564409/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621 |
0564409 | 02C0012 | France | ⤷ Sign Up | PRODUCT NAME: IMATINIB MESILATE; NAT. REGISTRATION NO/DATE: EU/1/01/198/001 20011107; FIRST REGISTRATION: LI - IKS 55 807 20010621 |
0564409 | C300086 | Netherlands | ⤷ Sign Up | PRODUCT NAME: IMATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET MESILAAT; NATL. REGISTRATION NO/DATE: EU/1/01/198/001 - 006 20011107; FIRST REGISTRATION: CH IKS 55807 20010621 |
0564409 | SPC/GB02/016 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: IMATINIB (INN I.E. NON INTELLECTUAL PROPRIETARY NAME) OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; REGISTERED: CH IKS-NR: 55807 20010621; UK SG(2001) D/292083 20011108 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |