PEMFEXY Drug Patent Profile
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Which patents cover Pemfexy, and when can generic versions of Pemfexy launch?
Pemfexy is a drug marketed by Eagle Pharms and is included in one NDA. There are two patents protecting this drug.
This drug has seven patent family members in five countries.
The generic ingredient in PEMFEXY is pemetrexed. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pemetrexed profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Pemfexy
A generic version of PEMFEXY was approved as pemetrexed by ACTAVIS on August 21st, 2020.
Summary for PEMFEXY
International Patents: | 7 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 87 |
Clinical Trials: | 22 |
Patent Applications: | 5,239 |
Drug Prices: | Drug price information for PEMFEXY |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PEMFEXY |
What excipients (inactive ingredients) are in PEMFEXY? | PEMFEXY excipients list |
DailyMed Link: | PEMFEXY at DailyMed |
![PEMFEXY drug patent expirations Drug patent expirations by year for PEMFEXY](/p/graph/s/t/PEMFEXY-patent-expirations.png)
![Drug Prices for PEMFEXY](/p/graph/drug-price/PEMFEXY.png)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PEMFEXY
Generic Entry Date for PEMFEXY*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;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 PEMFEXY
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
NRG Oncology | Phase 3 |
Genentech, Inc. | Phase 2 |
Liza Villaruz, MD | Phase 2 |
Pharmacology for PEMFEXY
Drug Class | Folate Analog Metabolic Inhibitor |
Mechanism of Action | Folic Acid Metabolism Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for PEMFEXY
US Patents and Regulatory Information for PEMFEXY
PEMFEXY is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of PEMFEXY is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting PEMFEXY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Crystalline forms of pemetrexed diacid and manufacturing processes therefor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Eagle Pharms | PEMFEXY | pemetrexed | SOLUTION;INTRAVENOUS | 209472-001 | Feb 8, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Eagle Pharms | PEMFEXY | pemetrexed | SOLUTION;INTRAVENOUS | 209472-001 | Feb 8, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for PEMFEXY
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Eli Lilly Nederland B.V. | Alimta | pemetrexed | EMEA/H/C/000564 Malignant pleural mesotheliomaAlimta in combination with cisplatin is indicated for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma.Non-small-cell lung cancerAlimta in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology.Alimta is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.Alimta is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology. |
Authorised | no | no | no | 2004-09-20 | |
KRKA d.d. | Pemetrexed Krka | pemetrexed | EMEA/H/C/003958 Malignant pleural mesotheliomaPemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Krka in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.Pemetrexed Krka is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.Pemetrexed Krka is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. |
Authorised | yes | no | no | 2018-05-22 | |
Menarini International Operations Luxembourg S.A. | Ciambra | pemetrexed | EMEA/H/C/003788 Malignant pleural mesothelioma, , Ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma., , Non-small cell lung cancer, , Ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology., , Ciambra is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy., , Ciambra is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology., |
Authorised | yes | no | no | 2015-12-02 | |
Fresenius Kabi Deutschland GmbH | Pemetrexed Fresenius Kabi | pemetrexed | EMEA/H/C/003895 Malignant pleural mesotheliomaPemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Fresenius Kabi in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.Pemetrexed Fresenius Kabi is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Fresenius Kabi is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. |
Authorised | yes | no | no | 2016-07-22 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for PEMFEXY
When does loss-of-exclusivity occur for PEMFEXY?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Canada
Patent: 62383
Estimated Expiration: ⤷ Try a Trial
Patent: 15436
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 12193
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 1405
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 51603
Estimated Expiration: ⤷ Try a Trial
Patent: 1619161
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering PEMFEXY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2015178501 | 新規な葉酸代謝拮抗薬の組み合わせ療法 (NOVEL ANTIFOLATE COMBINATION THERAPIES) | ⤷ Try a Trial |
Taiwan | I551603 | ⤷ Try a Trial | |
Spain | 2284660 | ⤷ Try a Trial | |
European Patent Office | 1313508 | COMPOSITION COMPRENANT UN ANTIFOLATE ET UN AGENT REDUCTEUR D'ACIDE METHYLMALONIQUE (COMBINATION CONTAINING AN ANTIFOLATE AND METHYLMALONIC ACID LOWERING AGENT) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PEMFEXY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0432677 | SPC/GB05/011 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920 |
0432677 | 7/2005 | Austria | ⤷ Try a Trial | PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |