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LEVOXYL Drug Profile
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» See Plans and PricingWhen do Levoxyl patents expire, and when can generic versions of Levoxyl launch?
Levoxyl is a drug marketed by King Pharms and is included in one NDA. There are three patents protecting this drug.
This drug has twenty-six patent family members in nine countries.
The generic ingredient in LEVOXYL is levothyroxine sodium. There are ten drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
US ANDA Litigation and Generic Entry Outlook for Levoxyl
A generic version of LEVOXYL was approved as levothyroxine sodium by MYLAN on June 5th, 2002.
Summary for LEVOXYL
| International Patents: | 26 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 55 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,601 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LEVOXYL |
| Drug Sales Revenues: | Drug sales revenues for LEVOXYL |
| DailyMed Link: | LEVOXYL at DailyMed |
Recent Clinical Trials for LEVOXYL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Children's Hospital of Philadelphia | N/A |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | N/A |
Pharmacology for LEVOXYL
| Drug Class | l-Thyroxine |
Paragraph IV (Patent) Challenges for LEVOXYL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LEVOXYL | TABLET;ORAL | levothyroxine sodium | 021301 |
US Patents and Regulatory Information for LEVOXYL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| King Pharms | LEVOXYL | levothyroxine sodium | TABLET;ORAL | 021301-011 | May 25, 2001 | AB1,AB3 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| King Pharms | LEVOXYL | levothyroxine sodium | TABLET;ORAL | 021301-010 | May 25, 2001 | AB1,AB3 | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| King Pharms | LEVOXYL | levothyroxine sodium | TABLET;ORAL | 021301-011 | May 25, 2001 | AB1,AB3 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| King Pharms | LEVOXYL | levothyroxine sodium | TABLET;ORAL | 021301-010 | May 25, 2001 | AB1,AB3 | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| King Pharms | LEVOXYL | levothyroxine sodium | TABLET;ORAL | 021301-001 | May 25, 2001 | AB1,AB3 | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for LEVOXYL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2002258397 | Start Trial |
| Canada | 2440190 | Start Trial |
| Mexico | PA03007338 | Start Trial |
| Canada | 2438907 | Start Trial |
| Canada | 2438641 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
