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-five patent family members in twenty 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: | 25 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,604 |
| Formulation / Manufacturing: | see details |
| 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.
Patents protecting OLPRUVA
Palatable compositions including sodium phenylbutyrate and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods of treating urea cycle disorders and maple syrup urine disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A UREA CYCLE DISORDER INVOLVING DEFICIENCIES OF CARBAMYLPHOSPHATE SYNTHETASE, ORNITHINE TRANSCARBAMYLASE, OR ARGININOSUCCINIC ACID SYNTHETASE
Palatable compositions including sodium phenylbutyrate and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860-006 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860-003 | Dec 22, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860-002 | Dec 22, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ 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 |
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 |
|---|---|---|---|
| Spain | 2922749 | ⤷ Sign Up | |
| 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 | ⤷ Sign Up |
| European Patent Office | 3429559 | COMPOSITIONS AU GOÛT AGRÉABLE COMPRENANT DU PHÉNYLBUTYRATE DE SODIUM ET LEURS UTILISATIONS (PALATABLE COMPOSITIONS INCLUDING SODIUM PHENYLBUTYRATE AND USES THEREOF) | ⤷ Sign Up |
| Canada | 3017573 | COMPOSITIONS AU GOUT AGREABLE COMPRENANT DU PHENYLBUTYRATE DE SODIUM ET LEURS UTILISATIONS (PALATABLE COMPOSITIONS INCLUDING SODIUM PHENYLBUTYRATE AND USES THEREOF) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OLPRUVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2822954 | 2018/031 | Ireland | ⤷ Sign Up | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625 |
| 0788511 | SPC/GB08/036 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425 |
| 1499331 | SPC/GB13/034 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313 |
| 1175904 | 2007C/048 | Belgium | ⤷ Sign Up | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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