TAMSULOSIN HYDROCHLORIDE Drug Patent Profile
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When do Tamsulosin Hydrochloride patents expire, and what generic alternatives are available?
Tamsulosin Hydrochloride is a drug marketed by Alkem Labs Ltd, Anchen Pharms, Ascent Pharms Inc, Aurobindo Pharma Ltd, Chartwell Rx, Impax Labs, Macleods Pharms Ltd, Mylan, Sandoz, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Wockhardt, and Zydus Pharms Usa Inc. and is included in fourteen NDAs.
The generic ingredient in TAMSULOSIN HYDROCHLORIDE is tamsulosin hydrochloride. There are thirty-three drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the tamsulosin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tamsulosin Hydrochloride
A generic version of TAMSULOSIN HYDROCHLORIDE was approved as tamsulosin hydrochloride by IMPAX LABS on March 2nd, 2010.
Summary for TAMSULOSIN HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 14 |
NDAs: | 14 |
Finished Product Suppliers / Packagers: | 41 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 198 |
Patent Applications: | 1,795 |
Formulation / Manufacturing: | see details |
DailyMed Link: | TAMSULOSIN HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for TAMSULOSIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hackensack Meridian Health | N/A |
NorthShore University HealthSystem | Phase 3 |
Benha University | N/A |
Pharmacology for TAMSULOSIN HYDROCHLORIDE
Drug Class | alpha-Adrenergic Blocker |
Mechanism of Action | Adrenergic alpha-Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for TAMSULOSIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for TAMSULOSIN HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FLOMAX | Capsules | tamsulosin hydrochloride | 0.4 mg | 020579 | 1 | 2004-12-20 |
US Patents and Regulatory Information for TAMSULOSIN HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alkem Labs Ltd | TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 207405-001 | Aug 11, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Macleods Pharms Ltd | TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 204645-001 | Jan 20, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Aurobindo Pharma Ltd | TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 202433-001 | Apr 30, 2013 | 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 |