Details for Patent: RE43797
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Which drugs does patent RE43797 protect, and when does it expire?
Patent RE43797 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 fifty-nine patent family members in twenty-two countries.
Summary for Patent: RE43797
| Title: | Methods of administering tetrahydrobiopterin |
| Abstract: | The present invention is directed to treatment methods of administering tetrahydrobiopterin, including in oral dosage forms, in intravenous formulations, and with food. Also disclosed herein are biopterin assays for measuring the amount of biopterin and metabolites of biopterin in a sample. |
| Inventor(s): | Oppenheimer; Daniel I. (Castro Valley, CA), Dorenbaum; Alejandro (Mill Valley, CA), Okhamafe; Augustus O. (Concord, CA) |
| Assignee: | Biomarin Pharmaceutical Inc. (Novato, CA) |
| Application Number: | 13/299,499 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent RE43797 |
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Patent Claim Types: see list of patent claims | Use; Dosage form; |
Drugs Protected by US Patent RE43797
| 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 RE43797
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2008240259 | ⤷ Sign Up | |||
| Australia | 2008347005 | ⤷ Sign Up | |||
| Brazil | PI0809470 | ⤷ Sign Up | |||
| Brazil | PI0821970 | ⤷ Sign Up | |||
| Canada | 2682598 | ⤷ Sign Up | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
