Dextroamphetamine - Generic Drug Details
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What are the generic drug sources for dextroamphetamine and what is the scope of patent protection?
Dextroamphetamine
is the generic ingredient in seven branded drugs marketed by Noven Pharms Inc, Impax Labs Inc, Able, Actavis Elizabeth, Dr Reddys Labs Sa, Nesher Pharms, Norvium Bioscience, Specgx Llc, Strides Pharma, Teva, Glaxosmithkline, Prasco, Tris Pharma Inc, Ani Pharms, Aurolife Pharma Llc, Avanthi Inc, Azurity, Barr, Epic Pharma Llc, Halsey, Lannett, Mast Mm, Novel Labs Inc, Nuvo Pharm, Purepac Pharm, Sandoz, Vitarine, Winder Labs Llc, Shire, and Ferndale Labs, and is included in forty-one NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Dextroamphetamine has thirty-three patent family members in twelve countries.
There are eighteen drug master file entries for dextroamphetamine. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for dextroamphetamine
International Patents: | 33 |
US Patents: | 6 |
Tradenames: | 7 |
Applicants: | 30 |
NDAs: | 41 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 17 |
Clinical Trials: | 32 |
Patent Applications: | 6,647 |
Drug Prices: | Drug price trends for dextroamphetamine |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dextroamphetamine |
What excipients (inactive ingredients) are in dextroamphetamine? | dextroamphetamine excipients list |
DailyMed Link: | dextroamphetamine at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for dextroamphetamine
Generic Entry Date for dextroamphetamine*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
SYSTEM;TRANSDERMAL |
*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 dextroamphetamine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The Beckwith Institute | Phase 4 |
Eva Szigethy | Phase 4 |
Vallon Pharmaceuticals, Inc. | Phase 1 |
Generic filers with tentative approvals for DEXTROAMPHETAMINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 30MG | CAPSULE, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 25MG | CAPSULE, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 20MG | CAPSULE, EXTENDED RELEASE;ORAL |
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 dextroamphetamine
Drug Class | Central Nervous System Stimulant |
Physiological Effect | Central Nervous System Stimulation |
US Patents and Regulatory Information for dextroamphetamine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Strides Pharma | DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 205077-001 | Jun 21, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Norvium Bioscience | DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 206735-003 | Jan 27, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Impax Labs Inc | DEXEDRINE SPANSULE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 017078-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | 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 |
International Patents for dextroamphetamine
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | 200628175 | Transdermal drug delivert device including an occlusive backing | ⤷ Sign Up |
Japan | 2015535253 | アンフェタミンの組成物及びアンフェタミンを経皮送達する方法 | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2014066585 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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