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, 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 fourteen NDAs.
The generic ingredient in TAMSULOSIN HYDROCHLORIDE is tamsulosin hydrochloride. There are thirty-three drug master file entries for this compound. Forty-three 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.
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Questions you can ask:
- What is the 5 year forecast for TAMSULOSIN HYDROCHLORIDE?
- What are the global sales for TAMSULOSIN HYDROCHLORIDE?
- What is Average Wholesale Price for TAMSULOSIN HYDROCHLORIDE?
Summary for TAMSULOSIN HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 14 |
| NDAs: | 14 |
| Finished Product Suppliers / Packagers: | 42 |
| Raw Ingredient (Bulk) Api Vendors: | 109 |
| Clinical Trials: | 201 |
| Patent Applications: | 1,795 |
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Macleods Pharms Ltd | TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 204645-001 | Jan 20, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Rx | TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 211885-001 | Oct 17, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms | TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 077630-001 | Apr 27, 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 |
