DrugPatentWatch Database Preview
ALIMTA Drug Profile
When do Alimta patents expire, and what generic alternatives are available?
Alimta is a drug marketed by Lilly and is included in one NDA. There is one patent protecting this drug and four Paragraph IV challenges.
This drug has eighteen patent family members in eleven countries.
The generic ingredient in ALIMTA is pemetrexed disodium. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pemetrexed disodium profile page.
US ANDA Litigation and Generic Entry Outlook for Alimta
Alimta was eligible for patent challenges on February 4, 2008.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 24, 2022. This may change due to patent challenges or generic licensing.
There have been fifteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are three tentative approvals for the generic drug (pemetrexed disodium), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for ALIMTA
| International Patents: | 18 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 73 |
| Clinical Trials: | 178 |
| Patent Applications: | 5,903 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ALIMTA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ALIMTA |
| DailyMed Link: | ALIMTA at DailyMed |
Generic Entry Opportunity Date for ALIMTA
Generic Entry Date for ALIMTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ALIMTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| NRG Oncology | Phase 3 |
| University of Sydney | Phase 3 |
| Australasian Lung Cancer Trials Group | Phase 3 |
Recent Litigation for ALIMTA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Eli Lilly and Company v. Eagle Pharmaceuticals, Inc. | 2017-09-11 |
| ELI LILLY AND COMPANY v. APOTEX, INC. | 2017-08-21 |
| ELI LILLY AND COMPANY v. HOSPIRA, INC. | 2016-12-21 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Apotex Inc. | 2016-07-14 |
| Wockhardt Bio AG | 2016-07-08 |
| Apotex Inc. | 2016-07-01 |
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 | NDA | Submissiondate |
|---|---|---|---|---|
| ALIMTA | POWDER;INTRAVENOUS | pemetrexed disodium | 021462 | 2016-10-06 |
| ALIMTA | POWDER;INTRAVENOUS | pemetrexed disodium | 021462 | 2012-06-27 |
| ALIMTA | POWDER;INTRAVENOUS | pemetrexed disodium | 021462 | 2008-07-01 |
| ALIMTA | POWDER;INTRAVENOUS | pemetrexed disodium | 021462 | 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 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-001 | Feb 4, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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 | Start Trial | Start Trial |
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-002 | Sep 7, 2007 | Start Trial | Start Trial |
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-001 | Feb 4, 2004 | Start Trial | Start Trial |
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-001 | Feb 4, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ALIMTA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 1313508 | Start Trial |
| Cyprus | 1107649 | Start Trial |
| Japan | 2014005304 | Start Trial |
| Denmark | 1313508 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ALIMTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0432677 | 7/2005 | Austria | Start Trial | PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920 |
| 0432677 | SPC/GB05/011 | United Kingdom | Start Trial | PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
