Tamsulosin hydrochloride - Generic Drug Details
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What are the generic drug sources for tamsulosin hydrochloride and what is the scope of patent protection?
Tamsulosin hydrochloride
is the generic ingredient in two branded drugs marketed by Sanofi, Alkem Labs Ltd, Ascent Pharms Inc, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Impax Labs, Macleods Pharms Ltd, Norvium Bioscience, Sandoz, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Wockhardt, and Zydus Pharms Usa Inc, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.There are thirty-two drug master file entries for tamsulosin hydrochloride. Forty-three suppliers are listed for this compound.
Summary for tamsulosin hydrochloride
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 15 |
NDAs: | 15 |
Drug Master File Entries: | 32 |
Finished Product Suppliers / Packagers: | 43 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 201 |
Patent Applications: | 2,963 |
What excipients (inactive ingredients) are in tamsulosin hydrochloride? | tamsulosin hydrochloride excipients list |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Pharms | TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 077630-001 | Apr 27, 2010 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Wockhardt | TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 078938-001 | Apr 27, 2010 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Impax Labs | TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 090377-001 | Mar 2, 2010 | 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 |
Expired US Patents for tamsulosin hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sanofi | FLOMAX | tamsulosin hydrochloride | CAPSULE;ORAL | 020579-001 | Apr 15, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi | FLOMAX | tamsulosin hydrochloride | CAPSULE;ORAL | 020579-001 | Apr 15, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi | FLOMAX | tamsulosin hydrochloride | CAPSULE;ORAL | 020579-001 | Apr 15, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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