DrugPatentWatch Database Preview
Biomarin Pharm Company Profile
What is the competitive landscape for BIOMARIN PHARM, and what generic alternatives to BIOMARIN PHARM drugs are available?
There are eleven US patents protecting BIOMARIN PHARM drugs.
There are seventy-nine patent family members on BIOMARIN PHARM drugs in twenty-four countries.
Summary for Biomarin Pharm
| International Patents: | 79 |
| US Patents: | 11 |
| Tradenames: | 1 |
| Ingredients: | 1 |
| NDAs: | 2 |
| Patent Litigation for Biomarin Pharm: | See patent lawsuits for Biomarin Pharm |
Drugs and US Patents for Biomarin Pharm
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065-001 | Dec 19, 2013 | RX | Yes | Yes | 9,216,178 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065-002 | Oct 27, 2015 | RX | Yes | No | 8,067,416*PED | ➤ Sign Up | Y | ➤ Sign Up | |||
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181-001 | Dec 13, 2007 | RX | Yes | Yes | 7,947,681*PED | ➤ Sign Up | Y | ➤ Sign Up | |||
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065-002 | Oct 27, 2015 | RX | Yes | No | 9,433,624 | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Paragraph IV (Patent) Challenges for BIOMARIN PHARM drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 100 mg | ➤ Subscribe | 2014-05-30 |
| ➤ Subscribe | Powder for Oral Solution | 500 mg/packet | ➤ Subscribe | 2016-12-20 |
| ➤ Subscribe | Powder for Oral Solution | 100 mg per packet | ➤ Subscribe | 2015-11-09 |
Non-Orange Book US Patents for Biomarin Pharm
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,475,360 | Method for dynamically providing scroll indicators | ➤ Sign Up |
| 8,324,210 | Pterin analogs | ➤ Sign Up |
| 8,344,139 | Process for preparing crystalline polymorphic forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride | ➤ Sign Up |
| 7,601,717 | Pterin analogs | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Biomarin Pharm Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Canada | 2682598 | ➤ Sign Up |
| Australia | 2005306686 | ➤ Sign Up |
| Spain | 2596827 | ➤ Sign Up |
| South Korea | 101721198 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
