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.
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Summary for ALIMTA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 344 |
| Patent Applications: | 6,205 |
| 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 |
|---|---|
| Regeneron Pharmaceuticals | Phase 2 |
| Regeneron Pharmaceuticals | Phase 2/Phase 3 |
| Liza Villaruz, MD | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-001 | Feb 4, 2004 | AP | RX | Yes | Yes | ⤷ 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 ALIMTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-002 | Sep 7, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-001 | Feb 4, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-001 | Feb 4, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-001 | Feb 4, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-002 | Sep 7, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-002 | Sep 7, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ALIMTA
See the table below for patents covering ALIMTA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 0505640 | ⤷ Sign Up | |
| Japan | 2017019852 | 新規な葉酸代謝拮抗薬の組み合わせ療法 (NOVEL ANTIFOLATE COMBINATION THERAPIES) | ⤷ Sign Up |
| Hungary | 218483 | Eljárás N-(pirrolo[2,3-d]pirimidin-3-il-acil)- glutaminsav-származékok és az ezeket tartalmazó gyógyszerkészítmények előállítására (PROCESS FOR THE PRODUCTION OF N-(PYRROLO[2,3-D]PYRIMIDINE-3-YL-ACYL)-GLUTAMINE-ACID DERIVATIVES AND THE PHARMACEUTICAL COMPOSITIONS CONTAINING THEM) | ⤷ Sign Up |
| Hong Kong | 1000920 | ⤷ Sign Up | |
| Hungary | 908147 | ⤷ Sign Up | |
| Japan | 5102928 | ⤷ Sign Up | |
| Cyprus | 1888 | Improved therapeutic method | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ALIMTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0432677 | 7/2005 | Austria | ⤷ Sign Up | PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920 |
| 0432677 | CA 2005 00008 | Denmark | ⤷ Sign Up | |
| 0432677 | 300181 | Netherlands | ⤷ Sign Up | 300181, 20101210, EXPIRES: 20151209 |
| 0432677 | SPC/GB05/011 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920 |
| 0432677 | 91147 | Luxembourg | ⤷ Sign Up | 91147, EXPIRES: 20151210 |
| 0432677 | C00432677/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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