OLPRUVA Drug Patent Profile
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When do Olpruva patents expire, and when can generic versions of Olpruva launch?
Olpruva is a drug marketed by Acer and is included in one NDA. There are three patents protecting this drug.
This drug has twenty-nine patent family members in twenty-one countries.
The generic ingredient in OLPRUVA is sodium phenylbutyrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Olpruva
A generic version of OLPRUVA was approved as sodium phenylbutyrate by SIGMAPHARM LABS LLC on March 22nd, 2013.
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Summary for OLPRUVA
International Patents: | 29 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 97 |
Clinical Trials: | 1 |
Patent Applications: | 1,712 |
Drug Prices: | Drug price information for OLPRUVA |
What excipients (inactive ingredients) are in OLPRUVA? | OLPRUVA excipients list |
DailyMed Link: | OLPRUVA at DailyMed |


Recent Clinical Trials for OLPRUVA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Jerry Vockley, MD, PhD | Phase 2 |
Acer Therapeutics Inc. | Phase 2 |
US Patents and Regulatory Information for OLPRUVA
OLPRUVA is protected by three US patents.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860-001 | Dec 22, 2022 | RX | Yes | No | 11,202,767 | ⤷ Try for Free | ⤷ Try for Free | ||||
Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860-006 | Dec 22, 2022 | RX | Yes | No | 11,154,521 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860-003 | Dec 22, 2022 | RX | Yes | No | 11,202,767 | ⤷ Try for Free | ⤷ Try for Free | ||||
Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860-002 | Dec 22, 2022 | RX | Yes | No | 11,202,767 | ⤷ Try for Free | ⤷ Try for Free | ||||
Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860-004 | Dec 22, 2022 | RX | Yes | Yes | 11,433,041 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860-003 | Dec 22, 2022 | RX | Yes | No | 11,154,521 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for OLPRUVA
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Eurocept International B. V. | Pheburane | sodium phenylbutyrate | EMEA/H/C/002500 Treatment of chronic management of urea-cycle disorders. |
Authorised | no | no | no | 2013-07-30 | |
Immedica Pharma AB | Ammonaps | sodium phenylbutyrate | EMEA/H/C/000219 Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase.It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy. |
Authorised | no | no | no | 1999-12-07 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for OLPRUVA
See the table below for patents covering OLPRUVA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2019509345 | フェニル酪酸ナトリウムを含む口当たりの良い組成物及びその使用 | ⤷ Try for Free |
Israel | 261777 | הרכבים טעימים הכוללים נתרן פנילביוטירייט ושימושים עבורם (Palatable compositions including sodium phenylbutyrate and uses thereof) | ⤷ Try for Free |
Denmark | 3429559 | ⤷ Try for Free | |
Japan | 2022106927 | フェニル酪酸ナトリウムを含む口当たりの良い組成物及びその使用 | ⤷ Try for Free |
South Korea | 102690703 | ⤷ Try for Free | |
Lithuania | 3429559 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OLPRUVA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1856135 | SPC/GB20/016 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTERED: UK EU/1/19/1405 (NI) 20200113; UK PLGB 12930/0022 20200113; UK PLGB 12930/0023 20200113 |
0480717 | SPC/GB98/025 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115 |
0579826 | SPC/GB02/042 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422 |
3141251 | SPC/GB20/075 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS: POLYETHYLENE GLYCOL 3350, SODIUM SULPH; REGISTERED: IS IS/1/17/063/01 20171016; UK PL 20011/0040 20171016 |
0290047 | SPC/GB97/078 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522 |
2932970 | SPC/GB18/041 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for OLPRUVA
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