TERIPARATIDE Drug Patent Profile
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Which patents cover Teriparatide, and when can generic versions of Teriparatide launch?
Teriparatide is a drug marketed by Apotex and Teva Pharms Usa and is included in two NDAs.
The generic ingredient in TERIPARATIDE is teriparatide. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the teriparatide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Teriparatide
A generic version of TERIPARATIDE was approved as teriparatide by APOTEX on November 16th, 2023.
Summary for TERIPARATIDE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 28 |
| Clinical Trials: | 150 |
| Drug Prices: | Drug price information for TERIPARATIDE |
| What excipients (inactive ingredients) are in TERIPARATIDE? | TERIPARATIDE excipients list |
| DailyMed Link: | TERIPARATIDE at DailyMed |
Recent Clinical Trials for TERIPARATIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Peking Union Medical College Hospital | N/A |
| Hartmut Malluche, MD | Phase 4 |
| National Institute on Aging (NIA) | Phase 4 |
Pharmacology for TERIPARATIDE
| Drug Class | Parathyroid Hormone Analog |
Anatomical Therapeutic Chemical (ATC) Classes for TERIPARATIDE
Paragraph IV (Patent) Challenges for TERIPARATIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FORTEO | Injection | teriparatide | 250 mcg/mL, 2.4 mL prefilled Pen | 021318 | 1 | 2015-07-27 |
US Patents and Regulatory Information for TERIPARATIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | TERIPARATIDE | teriparatide | SOLUTION;SUBCUTANEOUS | 211097-001 | Nov 16, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms Usa | TERIPARATIDE | teriparatide | SOLUTION;SUBCUTANEOUS | 208569-001 | Nov 16, 2023 | AP | RX | 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 |
EU/EMA Drug Approvals for TERIPARATIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| STADA Arzneimittel AG | Movymia | teriparatide | EMEA/H/C/004368 Movymia is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. |
Authorised | no | yes | no | 2017-01-11 | |
| Eli Lilly Nederland B.V. | Forsteo | teriparatide | EMEA/H/C/000425 Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and nonvertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. |
Authorised | no | no | no | 2003-06-10 | |
| Gedeon Richter Plc. | Terrosa | teriparatide | EMEA/H/C/003916 Terrosa is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. |
Authorised | no | yes | no | 2017-01-04 | |
| EuroGenerics Holdings B.V. | Qutavina | teriparatide | EMEA/H/C/005388 Qutavina is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. |
Withdrawn | no | yes | no | 2020-08-27 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
