APREPITANT Drug Patent Profile
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When do Aprepitant patents expire, and when can generic versions of Aprepitant launch?
Aprepitant is a drug marketed by Glenmark Speclt, Sandoz, and Torrent. and is included in three NDAs.
The generic ingredient in APREPITANT is aprepitant. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aprepitant profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Aprepitant
A generic version of APREPITANT was approved as aprepitant by SANDOZ on September 24th, 2012.
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Questions you can ask:
- What is the 5 year forecast for APREPITANT?
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- What is Average Wholesale Price for APREPITANT?
Summary for APREPITANT
Recent Clinical Trials for APREPITANT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hubei Cancer Hospital | N/A |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Phase 4 |
| Guangxi Medical University | Phase 3 |
Pharmacology for APREPITANT
Anatomical Therapeutic Chemical (ATC) Classes for APREPITANT
Paragraph IV (Patent) Challenges for APREPITANT
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| APONVIE | Intravenous Emulsion | aprepitant | 32 mg/4.4 mL | 216457 | 1 | 2023-11-07 |
| CINVANTI | Intravenous Emulsion | aprepitant | 130 mg/18 mL | 209296 | 1 | 2022-04-29 |
| EMEND | for Oral Suspension | aprepitant | 125 mg/Kit | 207865 | 1 | 2016-11-23 |
| EMEND | Capsule | aprepitant | 40 mg, 80 mg and 125 mg | 021549 | 1 | 2008-11-03 |
US Patents and Regulatory Information for APREPITANT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glenmark Speclt | APREPITANT | aprepitant | CAPSULE;ORAL | 207777-001 | Oct 12, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Torrent | APREPITANT | aprepitant | CAPSULE;ORAL | 211835-001 | Oct 21, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | APREPITANT | aprepitant | CAPSULE;ORAL | 090999-001 | Sep 24, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Torrent | APREPITANT | aprepitant | CAPSULE;ORAL | 211835-002 | Oct 21, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glenmark Speclt | APREPITANT | aprepitant | CAPSULE;ORAL | 207777-002 | Oct 12, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glenmark Speclt | APREPITANT | aprepitant | CAPSULE;ORAL | 207777-003 | Oct 12, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | APREPITANT | aprepitant | CAPSULE;ORAL | 090999-003 | Sep 24, 2012 | AB | 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 |
EU/EMA Drug Approvals for APREPITANT
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Merck Sharp & Dohme B.V. | Emend | aprepitant | EMEA/H/C/000527 Emend 40 mg hard capsules is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.Emend is also available as 80 mg and 125 mg hard capsules for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12 (see separate Summary of Product Characteristics).Emend is also available as 165 mg hard capsules for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.Emend is also available as powder for oral suspension for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in children, toddlers and infants from the age of 6 months to less than 12 years.Emend 80 mg, 125 mg, 165 mg hard capsules and Emend powder for oral suspension are given as part of combination therapy. |
Authorised | no | no | no | 2003-11-11 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
