ALIMTA Drug Patent Profile
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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 are twenty-nine drug master file entries for this compound. Twenty-two 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: | 4,945 |
| 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 |


