ALIMTA Drug Patent Profile
When do Alimta patents expire, and when can generic versions of Alimta launch?
Alimta is a drug marketed by Lilly and is included in one NDA.
The generic ingredient in ALIMTA is pemetrexed disodium. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the pemetrexed disodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Alimta
A generic version of ALIMTA was approved as pemetrexed disodium by ACCORD HLTHCARE on May 25th, 2022.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for ALIMTA?
- What are the global sales for ALIMTA?
- What is Average Wholesale Price for ALIMTA?
Summary for ALIMTA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 59 |
| Clinical Trials: | 345 |
| Patent Applications: | 4,919 |
| Drug Prices: | Drug price information for ALIMTA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ALIMTA |
| What excipients (inactive ingredients) are in ALIMTA? | ALIMTA excipients list |
| DailyMed Link: | ALIMTA at DailyMed |
Recent Clinical Trials for ALIMTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Saint John's Cancer Institute | PHASE2 |
| Chordoma Foundation | PHASE2 |
| Regeneron Pharmaceuticals | Phase 2 |
Pharmacology for ALIMTA
| Drug Class | Folate Analog Metabolic Inhibitor |
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Paragraph IV (Patent) Challenges for ALIMTA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ALIMTA | For Injection | pemetrexed disodium | 750 mg/vial | 021462 | 1 | 2016-10-06 |
| ALIMTA | For Injection | pemetrexed disodium | 1000 mg/vial | 021462 | 1 | 2012-06-27 |
| ALIMTA | For Injection | pemetrexed disodium | 100 mg/vial | 021462 | 1 | 2008-07-01 |
| ALIMTA | For Injection | pemetrexed disodium | 500 mg/vial | 021462 | 2 | 2008-02-04 |
US Patents and Regulatory Information for ALIMTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-002 | Sep 7, 2007 | AP | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-001 | Feb 4, 2004 | AP | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ALIMTA
See the table below for patents covering ALIMTA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 126700 | ⤷ Start Trial | |
| Australia | 640524 | ⤷ Start Trial | |
| Australia | 8457091 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ALIMTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0432677 | 91147 | Luxembourg | ⤷ Start Trial | 91147, EXPIRES: 20151210 |
| 0432677 | CA 2005 00008 | Denmark | ⤷ Start Trial | |
| 0432677 | 300181 | Netherlands | ⤷ Start Trial | 300181, 20101210, EXPIRES: 20151209 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |


