PEMFEXY Drug Patent Profile
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When do Pemfexy patents expire, 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.
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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: | 24 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PEMFEXY
*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 |
|---|---|
| SCRI Development Innovations, LLC | Phase 2 |
| Pfizer | Phase 2 |
| NRG Oncology | Phase 3 |
Pharmacology for PEMFEXY
| Drug Class | Folate Analog Metabolic Inhibitor |
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Crystalline forms of pemetrexed diacid and manufacturing processes therefor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Eagle Pharms | PEMFEXY | pemetrexed | SOLUTION;INTRAVENOUS | 209472-001 | Feb 8, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | |
| medac Gesellschaft für klinische Spezialpräparate mbH | Pemetrexed medac | pemetrexed | EMEA/H/C/003905 Malignant pleural mesothelioma Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma., , Non-small cell lung cancer Pemetrexed medac 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 medac 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 medac 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 | 2015-11-26 | |
| Actavis Group PTC ehf | Armisarte (previously Pemetrexed Actavis) | pemetrexed | EMEA/H/C/004109 Malignant pleural mesotheliomaPemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed 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 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 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 | 2016-01-18 | |
| Pfizer Europe MA EEIG | Pemetrexed Pfizer (previously Pemetrexed Hospira) | pemetrexed | EMEA/H/C/003970 Malignant pleural mesotheliomaPemetrexed Pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Pfizer 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 Pfizer 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 Pfizer 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 | 2015-11-19 | |
| >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
Patent: FORMES CRISTALLINES DU DIACIDE DE PEMETREXED ET LEURS PROCEDES DE PRODUCTION (CRYSTALLINE FORMS OF PEMETREXED DIACID AND MANUFACTURING PROCESSES THEREFOR)
Estimated Expiration: ⤷ Sign Up
Patent: 15436
Patent: FORMES CRISTALLINES DU DIACIDE DE PEMETREXED ET LEURS PROCEDES DE PRODUCTION (CRYSTALLINE FORMS OF PEMETREXED DIACID AND MANUFACTURING PROCESSES THEREFOR)
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 12193
Patent: FORMES CRISTALLINES DU DIACIDE DE PÉMÉTREXED ET LEURS PROCÉDÉS DE PRODUCTION (CRYSTALLINE FORMS OF PEMETREXED DIACID AND MANUFACTURING PROCESSES THEREFOR)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 1405
Patent: צורות גבישיות של פמטרקסד די-חומצה ושיטות להכנתן (Crystalline forms of pemetrexed diacid and manufacturing processes therefor)
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 51603
Estimated Expiration: ⤷ Sign Up
Patent: 1619161
Patent: Crystalline forms of pemetrexed diacid and manufacture processes therefor
Estimated Expiration: ⤷ Sign Up
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 | 2014005304 | NOVEL ANTIFOLATE COMBINATION THERAPIES | ⤷ Sign Up |
| Japan | 2015178501 | 新規な葉酸代謝拮抗薬の組み合わせ療法 (NOVEL ANTIFOLATE COMBINATION THERAPIES) | ⤷ Sign Up |
| Japan | 5102928 | ⤷ Sign Up | |
| Austria | 359823 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 0202093 | ⤷ 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 |
| World Intellectual Property Organization (WIPO) | 2016068796 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920 |
| 0432677 | 7/2005 | Austria | ⤷ Sign Up | 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 |
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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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