FOSAPREPITANT DIMEGLUMINE - Generic Drug Details
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What are the generic drug sources for fosaprepitant dimeglumine and what is the scope of patent protection?
Fosaprepitant dimeglumine
is the generic ingredient in three branded drugs marketed by Merck And Co Inc, Accord Hlthcare, Apotex, Arthur Grp, Aspiro, Baxter Hlthcare Corp, Be Pharms, Chia Tai Tianqing, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Geneyork Pharms, Lupin Ltd, MSN, Mylan Labs Ltd, Navinta Llc, Piramal Critical, Qilu Pharm Hainan, Sandoz, Teva Pharms Usa, and Steriscience, and is included in twenty-one NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Fosaprepitant dimeglumine has two patent family members in two countries.
There are eleven drug master file entries for fosaprepitant dimeglumine. Twenty-three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for FOSAPREPITANT DIMEGLUMINE
International Patents: | 2 |
US Patents: | 2 |
Tradenames: | 3 |
Applicants: | 21 |
NDAs: | 21 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 23 |
Raw Ingredient (Bulk) Api Vendors: | 125 |
Clinical Trials: | 17 |
Patent Applications: | 1,299 |
Drug Prices: | Drug price trends for FOSAPREPITANT DIMEGLUMINE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FOSAPREPITANT DIMEGLUMINE |
What excipients (inactive ingredients) are in FOSAPREPITANT DIMEGLUMINE? | FOSAPREPITANT DIMEGLUMINE excipients list |
DailyMed Link: | FOSAPREPITANT DIMEGLUMINE at DailyMed |
Recent Clinical Trials for FOSAPREPITANT DIMEGLUMINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Fujian Shengdi Pharmaceutical Co., Ltd. | Phase 3 |
Xijing Hospital | N/A |
bahria international hospital | Phase 3 |
Generic filers with tentative approvals for FOSAPREPITANT DIMEGLUMINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | UNKNOWN | UNKNOWN |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for FOSAPREPITANT DIMEGLUMINE
Drug Class | Substance P/Neurokinin-1 Receptor Antagonist |
Mechanism of Action | Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors Neurokinin 1 Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for FOSAPREPITANT DIMEGLUMINE
Paragraph IV (Patent) Challenges for FOSAPREPITANT DIMEGLUMINE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EMEND | Injection | fosaprepitant dimeglumine | 150 mg/vial | 022023 | 2 | 2012-01-25 |
US Patents and Regulatory Information for FOSAPREPITANT DIMEGLUMINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin Ltd | FOSAPREPITANT DIMEGLUMINE | fosaprepitant dimeglumine | POWDER;INTRAVENOUS | 210689-001 | Sep 5, 2019 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Mylan Labs Ltd | FOSAPREPITANT DIMEGLUMINE | fosaprepitant dimeglumine | POWDER;INTRAVENOUS | 204015-001 | Sep 5, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Steriscience | FOCINVEZ | fosaprepitant dimeglumine | SOLUTION;INTRAVENOUS | 216686-001 | Aug 22, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Chia Tai Tianqing | FOSAPREPITANT DIMEGLUMINE | fosaprepitant dimeglumine | POWDER;INTRAVENOUS | 212143-001 | Mar 3, 2021 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Eugia Pharma | FOSAPREPITANT DIMEGLUMINE | fosaprepitant dimeglumine | POWDER;INTRAVENOUS | 210625-001 | Jan 12, 2021 | AP | RX | No | No | ⤷ 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 FOSAPREPITANT DIMEGLUMINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck And Co Inc | EMEND | fosaprepitant dimeglumine | POWDER;INTRAVENOUS | 022023-001 | Jan 25, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Merck And Co Inc | EMEND | fosaprepitant dimeglumine | POWDER;INTRAVENOUS | 022023-001 | Jan 25, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Merck And Co Inc | EMEND | fosaprepitant dimeglumine | POWDER;INTRAVENOUS | 022023-002 | Nov 12, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Merck And Co Inc | EMEND | fosaprepitant dimeglumine | POWDER;INTRAVENOUS | 022023-002 | Nov 12, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Merck And Co Inc | EMEND | fosaprepitant dimeglumine | POWDER;INTRAVENOUS | 022023-002 | Nov 12, 2010 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FOSAPREPITANT DIMEGLUMINE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2019221815 | ⤷ Sign Up | |
China | 112243376 | 福沙匹坦的组合物和制备方法 (Fosaprepitant composition and preparation method thereof) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FOSAPREPITANT DIMEGLUMINE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0748320 | SPC/GB08/021 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: FOSAPREPITANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE BIS(N-METHYL-D-GLUCAMINE)SALT; REGISTERED: UK EU/1/07/437/001 20080111; UK EU/1/07/437/002 20080111 |
0748320 | 08C0019 | France | ⤷ Sign Up | PRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 20080111 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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