LISDEXAMFETAMINE DIMESYLATE Drug Patent Profile
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Which patents cover Lisdexamfetamine Dimesylate, and when can generic versions of Lisdexamfetamine Dimesylate launch?
Lisdexamfetamine Dimesylate is a drug marketed by Actavis Elizabeth, Alkem Labs Ltd, Amneal, Apotex, Ascent Pharms Inc, Hikma, Lannett Co Inc, Mylan, Norwich, Prinston Inc, Rhodes Pharms, Specgx Llc, Sun Pharm Inds Inc, MSN, and Teva Pharms. and is included in seventeen NDAs.
The generic ingredient in LISDEXAMFETAMINE DIMESYLATE is lisdexamfetamine dimesylate. Fifteen suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lisdexamfetamine Dimesylate
A generic version of LISDEXAMFETAMINE DIMESYLATE was approved as lisdexamfetamine dimesylate by ALKEM LABS LTD on August 25th, 2023.
Summary for LISDEXAMFETAMINE DIMESYLATE
Recent Clinical Trials for LISDEXAMFETAMINE DIMESYLATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Minnesota | Early Phase 1 |
Purdue Pharma, Canada | Phase 4 |
University of Birmingham | N/A |
Pharmacology for LISDEXAMFETAMINE DIMESYLATE
Drug Class | Central Nervous System Stimulant |
Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for LISDEXAMFETAMINE DIMESYLATE
Anatomical Therapeutic Chemical (ATC) Classes for LISDEXAMFETAMINE DIMESYLATE
Paragraph IV (Patent) Challenges for LISDEXAMFETAMINE DIMESYLATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
VYVANSE | Capsules | lisdexamfetamine dimesylate | 10 mg | 021977 | 1 | 2020-04-09 |
VYVANSE | Capsules | lisdexamfetamine dimesylate | 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg | 021977 | 6 | 2011-02-23 |
US Patents and Regulatory Information for LISDEXAMFETAMINE DIMESYLATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rhodes Pharms | LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 215330-003 | Aug 25, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Msn | LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 218306-005 | Feb 2, 2024 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Hikma | LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 202827-006 | Aug 25, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Ascent Pharms Inc | LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 217442-005 | Aug 25, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sun Pharm Inds Inc | LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 214484-003 | Aug 25, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Teva Pharms | LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 215415-006 | Aug 25, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mylan | LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 202835-001 | Aug 25, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |