Details for Patent: 8,067,416
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Which drugs does patent 8,067,416 protect, and when does it expire?
Patent 8,067,416 protects KUVAN and is included in two NDAs.
Protection for KUVAN has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.
This patent has twenty-seven patent family members in eighteen countries.
Summary for Patent: 8,067,416
| Title: | Methods and compositions for the treatment of metabolic disorders |
| Abstract: | The present invention is directed to a novel methods and compositions for the therapeutic intervention in hyperphenylalaninemia. More specifically, the specification describes methods and compositions for treating various types of phenylketonurias using compositions comprising BH4. Combination therapies of BH4 and other therapeutic regimens are contemplated. |
| Inventor(s): | Oppenheimer; Daniel I. (Castro Valley, CA), Kakkis; Emil D. (Novato, CA), Price; Fredric D. (Bedford, NY), Dorenbaum; Alejandro (Mill Valley, CA), Moser; Rudolf (Schaffhausen, CH), Groehn; Viola (Dachsen, CH), Egger; Thomas (Kempthal, CH), Blatter; Fritz (Reinach, CH) |
| Assignee: | Merck Eprova AG (Schaffhausen, CH) Biomarin Pharmaceutical Inc. (Novato, CA) |
| Application Number: | 12/508,209 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 8,067,416 |
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Patent Claim Types: see list of patent claims | Use; Delivery; |
Drugs Protected by US Patent 8,067,416
| 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 | POWDER;ORAL | 205065-001 | Dec 19, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065-002 | Oct 27, 2015 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| 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 |
International Family Members for US Patent 8,067,416
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2004291149 | ⤷ Sign Up | |||
| Brazil | PI0416566 | ⤷ Sign Up | |||
| Canada | 2545584 | ⤷ Sign Up | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
