Hytrin is a drug owned by Abbott Laboratories Pharmaceutical Products Div. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 29, 2013. Details of Hytrin's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5412095 | Terazosin monohydrochloride and processes and intermediate for its production |
Apr, 2013
(11 years ago) |
Expired
|
| US5294615 | Terazosin polymorph and pharmaceutical composition |
Apr, 2013
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Hytrin is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Hytrin's family patents as well as insights into ongoing legal events on those patents.
Hytrin's Family Patents
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Generic Launch
Generic Release Date:
Hytrin's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 29, 2013 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Hytrin Generic API suppliers:
Terazosin Hydrochloride is the generic name for the brand Hytrin. 11 different companies have already filed for the generic of Hytrin, with Norvium Bioscience having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Hytrin's generic
How can I launch a generic of Hytrin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Hytrin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Hytrin's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Hytrin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg, 2 mg, 5 mg and 10 mg | |||||
| 1 mg, 2 mg, 5 mg and 10 mg |
Alternative Brands for Hytrin
Hytrin which is used for treating hypertension and symptomatic benign prostatic hyperplasia., has several other brand drugs in the same treatment category and using the same active ingredient (Terazosin Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie |
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| Adhera |
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| Allergan |
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| Ani Pharms |
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| Azurity |
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| Boehringer Ingelheim |
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| Cosette |
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| Noden Pharma |
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| Novartis |
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| Upjohn |
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| Waylis Therap |
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Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Terazosin Hydrochloride. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Novitium Pharma |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Terazosin Hydrochloride, Hytrin's active ingredient. Check the complete list of approved generic manufacturers for Hytrin
About Hytrin
Hytrin is a drug owned by Abbott Laboratories Pharmaceutical Products Div. It is used for treating hypertension and symptomatic benign prostatic hyperplasia. Hytrin uses Terazosin Hydrochloride as an active ingredient. Hytrin was launched by Abbott in 1987.
Approval Date:
Hytrin was approved by FDA for market use on 07 August, 1987.
Active Ingredient:
Hytrin uses Terazosin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Terazosin Hydrochloride ingredient
Treatment:
Hytrin is used for treating hypertension and symptomatic benign prostatic hyperplasia.
Dosage:
Hytrin is available in the following dosage forms - tablet form for oral use, capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 1MG BASE | TABLET | Discontinued | ORAL |
| EQ 2MG BASE | TABLET | Discontinued | ORAL |
| EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |
| EQ 5MG BASE | TABLET | Discontinued | ORAL |
| EQ 10MG BASE | TABLET | Discontinued | ORAL |
| EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |
| EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |
| EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |