Details for Patent: 8,003,126
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Which drugs does patent 8,003,126 protect, and when does it expire?
Patent 8,003,126 protects KUVAN and is included in one NDA.
Protection for KUVAN has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.
This patent has sixteen patent family members in fourteen countries.
Summary for Patent: 8,003,126
| Title: | Stable tablet formulation |
| Abstract: | The present invention is directed to a stable solid formulations of tetrahydrobiopterin, processes for producing them, and treatment methods using such formulations. |
| Inventor(s): | Jungles; Steven (Novato, CA), Henderson; Mark (Larkspur, CA), Sluzky; Victoria (Corte Madera, CA), Baffi; Robert (Moraga, CA) |
| Assignee: | Biomarin Pharmaceutical Inc. (Novato, CA) |
| Application Number: | 10/563,418 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 8,003,126 |
|
Patent Claim Types: see list of patent claims | Formulation; Compound; Dosage form; |
Drugs Protected by US Patent 8,003,126
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181-001 | Dec 13, 2007 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
Foreign Priority and PCT Information for Patent: 8,003,126
| PCT Information | |||
| PCT Filed | November 16, 2005 | PCT Application Number: | PCT/US2005/041252 |
| PCT Publication Date: | May 26, 2006 | PCT Publication Number: | WO2006/055511 |
International Family Members for US Patent 8,003,126
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Argentina | 052238 | ⤷ Sign Up | |||
| Australia | 2005306686 | ⤷ Sign Up | |||
| Brazil | PI0517088 | ⤷ Sign Up | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
