DEXLANSOPRAZOLE Drug Patent Profile
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Which patents cover Dexlansoprazole, and what generic alternatives are available?
Dexlansoprazole is a drug marketed by Mylan, Par Pharm Inc, and Twi Pharms. and is included in three NDAs.
The generic ingredient in DEXLANSOPRAZOLE is dexlansoprazole. There are seventeen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dexlansoprazole
A generic version of DEXLANSOPRAZOLE was approved as dexlansoprazole by PAR PHARM INC on April 19th, 2017.
Summary for DEXLANSOPRAZOLE
US Patents: | 0 |
Applicants: | 3 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 62 |
Clinical Trials: | 51 |
Patent Applications: | 599 |
Drug Prices: | Drug price information for DEXLANSOPRAZOLE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DEXLANSOPRAZOLE |
What excipients (inactive ingredients) are in DEXLANSOPRAZOLE? | DEXLANSOPRAZOLE excipients list |
DailyMed Link: | DEXLANSOPRAZOLE at DailyMed |
Recent Clinical Trials for DEXLANSOPRAZOLE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Karachi | Phase 1 |
SAMI Pharmaceutical, Karachi Pakistan | Phase 1 |
Taipei Veterans General Hospital, Taiwan | N/A |
Pharmacology for DEXLANSOPRAZOLE
Drug Class | Proton Pump Inhibitor |
Mechanism of Action | Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for DEXLANSOPRAZOLE
Anatomical Therapeutic Chemical (ATC) Classes for DEXLANSOPRAZOLE
Paragraph IV (Patent) Challenges for DEXLANSOPRAZOLE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
DEXILANT | Delayed-release Capsules | dexlansoprazole | 30 mg | 022287 | 1 | 2010-11-30 |
US Patents and Regulatory Information for DEXLANSOPRAZOLE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | DEXLANSOPRAZOLE | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 205205-001 | Jan 19, 2024 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Par Pharm Inc | DEXLANSOPRAZOLE | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 202294-001 | Apr 19, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan | DEXLANSOPRAZOLE | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 205205-002 | Jan 19, 2024 | 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 |