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, Sandoz, Specgx Llc, Sun Pharm Inds Inc, MSN, and Teva Pharms. and is included in eighteen NDAs.
The generic ingredient in LISDEXAMFETAMINE DIMESYLATE is lisdexamfetamine dimesylate. Seventeen 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.
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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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ascent Pharms Inc | LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 217068-005 | Aug 25, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 202827-006 | Aug 25, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ascent Pharms Inc | LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 217442-005 | Aug 25, 2023 | 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 |
