HYDROXYPROGESTERONE CAPROATE Drug Patent Profile
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When do Hydroxyprogesterone Caproate patents expire, and when can generic versions of Hydroxyprogesterone Caproate launch?
Hydroxyprogesterone Caproate is a drug marketed by Allergan, Epic Pharma Llc, Aspen Global Inc, and Eugia Pharma. and is included in four NDAs.
The generic ingredient in HYDROXYPROGESTERONE CAPROATE is hydroxyprogesterone caproate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydroxyprogesterone caproate profile page.
Summary for HYDROXYPROGESTERONE CAPROATE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 30 |
| Patent Applications: | 5,401 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for HYDROXYPROGESTERONE CAPROATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for HYDROXYPROGESTERONE CAPROATE |
| What excipients (inactive ingredients) are in HYDROXYPROGESTERONE CAPROATE? | HYDROXYPROGESTERONE CAPROATE excipients list |
| DailyMed Link: | HYDROXYPROGESTERONE CAPROATE at DailyMed |
Recent Clinical Trials for HYDROXYPROGESTERONE CAPROATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bezmialem Vakif University | N/A |
| Assiut University | Phase 4 |
| Aswan University Hospital | N/A |
Pharmacology for HYDROXYPROGESTERONE CAPROATE
| Drug Class | Progestin |
Anatomical Therapeutic Chemical (ATC) Classes for HYDROXYPROGESTERONE CAPROATE
Paragraph IV (Patent) Challenges for HYDROXYPROGESTERONE CAPROATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MAKENA (AUTOINJECTOR) | Injection (Auto- injector) | hydroxyprogesterone caproate | 275 mg/1.1 mL | 021945 | 1 | 2020-09-28 |
US Patents and Regulatory Information for HYDROXYPROGESTERONE CAPROATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan | HYDROXYPROGESTERONE CAPROATE | hydroxyprogesterone caproate | INJECTABLE;INJECTION | 017439-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aspen Global Inc | HYDROXYPROGESTERONE CAPROATE | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 200271-001 | Aug 24, 2015 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Allergan | HYDROXYPROGESTERONE CAPROATE | hydroxyprogesterone caproate | INJECTABLE;INJECTION | 017439-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Epic Pharma Llc | HYDROXYPROGESTERONE CAPROATE | hydroxyprogesterone caproate | INJECTABLE;INJECTION | 018004-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Eugia Pharma | HYDROXYPROGESTERONE CAPROATE | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 211142-001 | May 9, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
