PHOTREXA Drug Patent Profile
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Which patents cover Photrexa, and what generic alternatives are available?
Photrexa is a drug marketed by Glaukos and is included in one NDA.
The generic ingredient in PHOTREXA is riboflavin 5'-phosphate sodium. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the riboflavin 5'-phosphate sodium profile page.
Summary for PHOTREXA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 19 |
| Clinical Trials: | 2 |
| Patent Applications: | 5 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | PHOTREXA at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for PHOTREXA
Generic Entry Date for PHOTREXA*:
Constraining patent/regulatory exclusivity:
TREATMENT OF CORNEAL ECTASIA FOLLOWING REFRACTIVE SURGERY NDA:
Dosage:
SOLUTION/DROPS;OPHTHALMIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for PHOTREXA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Avedro, Inc. | Phase 4 |
| Comprehensive EyeCare of Central Ohio | Phase 4 |
| Glaukos Corporation | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for PHOTREXA
US Patents and Regulatory Information for PHOTREXA
PHOTREXA is protected by zero US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of PHOTREXA is See Plans and Pricing.
This potential generic entry date is based on TREATMENT OF CORNEAL ECTASIA FOLLOWING REFRACTIVE SURGERY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
FDA Regulatory Exclusivity protecting PHOTREXA
TREATMENT OF CORNEAL ECTASIA FOLLOWING REFRACTIVE SURGERY
Exclusivity Expiration: See Plans and Pricing
TREATMENT OF PROGRESSIVE KERATOCONUS
Exclusivity Expiration: See Plans and Pricing
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaukos | PHOTREXA | riboflavin 5'-phosphate sodium | SOLUTION/DROPS;OPHTHALMIC | 203324-001 | Apr 15, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Glaukos | PHOTREXA VISCOUS IN DEXTRAN 20% | riboflavin 5'-phosphate sodium | SOLUTION/DROPS;OPHTHALMIC | 203324-002 | Apr 15, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Glaukos | PHOTREXA | riboflavin 5'-phosphate sodium | SOLUTION/DROPS;OPHTHALMIC | 203324-001 | Apr 15, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Glaukos | PHOTREXA VISCOUS IN DEXTRAN 20% | riboflavin 5'-phosphate sodium | SOLUTION/DROPS;OPHTHALMIC | 203324-002 | Apr 15, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
