Applicant, as named in the Orange Book
Bayer Hlthcare
Part of Bayer AG
Company and ticker: cliffwatch mapping, checked against SEC EDGAR
Next listed expiry: Natazia on 30 Jan 2028. 15 products with live protection, 14 without.
Products with listed protection
| Drug | Earliest generic entry |
|---|---|
| Natazia NDA 022252 dienogest; estradiol valerate | 30 Jan 2028 patent, carve-out possible |
| Astepro Allergy NDA 213872 azelastine hydrochloride | 4 Jun 2028 patent |
| Children's Astepro Allergy NDA 213872 azelastine hydrochloride | 4 Jun 2028 patent |
| Nexavar NDA 021923 sorafenib tosylate | 10 Sep 2028 patent |
| Kyleena NDA 208224 levonorgestrel | 16 Sep 2029 patent, carve-out possible |
| Mirena NDA 021225 levonorgestrel | 16 Sep 2029 patent, carve-out possible |
| Skyla NDA 203159 levonorgestrel | 16 Sep 2029 patent, carve-out possible |
| Beyaz NDA 022532 drospirenone; ethinyl estradiol; levomefolate calcium | 17 Jul 2030 patent |
| Safyral NDA 022574 drospirenone; ethinyl estradiol; levomefolate calcium | 17 Jul 2030 patent |
| Angeliq NDA 021355 · 2 strengths drospirenone; estradiol | 22 Oct 2031 patent |
| Stivarga NDA 203085 regorafenib | 9 Jul 2032 patent |
| Adempas NDA 204819 · 5 strengths riociguat | 18 Feb 2034 patent |
| Kerendia NDA 215341 · 3 strengths finerenone | 29 Jul 2035 patent |
| Vitrakvi NDA 210861 · 2 strengths larotrectinib sulfate | 16 May 2037 patent, carve-out possible |
| Lynkuet NDA 219469 elinzanetant | 14 May 2045 patent, carve-out possible |
Recent events
- Gadavist · Generic approved · ANDA 215957, Ge HlthcareApproved 29 Jun 2026Detected 25 Oct 2026
- Angeliq · First generic approved · ANDA 218031, Novast LabsApproved 28 Oct 2025Detected 25 Oct 2026
- Angeliq · Generic approved · ANDA 218031, Novast LabsApproved 28 Oct 2025Detected 25 Oct 2026
- Gadavist · Generic approved · ANDA 219287, Viwit PharmApproved 11 Jun 2026Detected 25 Oct 2026
- Kerendia · Generic tentatively approved · ANDA 220684, Apotex IncTentative approval 27 Aug 2026Detected 25 Oct 2026
- Avelox · Generic approved · ANDA 209143, Macleods PharmsApproved 2 Mar 2026Detected 25 Oct 2026
- Climara Pro · First generic approved · ANDA 220407, Zydus PharmsApproved 19 Oct 2026Detected 25 Oct 2026
- Climara Pro · Generic approved · ANDA 220407, Zydus PharmsApproved 19 Oct 2026Detected 25 Oct 2026
- Gadavist · Generic approved · ANDA 219146, ZenaraApproved 8 Jun 2026Detected 25 Oct 2026
- Levitra · Enters 12-month window basis: patent, carve-out possibleListed date 23 Jul 2027Detected 24 Oct 2026
- Levitra · Enters 12-month window basis: patent, carve-out possibleListed date 23 Jul 2027Detected 24 Oct 2026
- Levitra · Enters 12-month window basis: patent, carve-out possibleListed date 23 Jul 2027Detected 24 Oct 2026
- Levitra · Enters 12-month window basis: patent, carve-out possibleListed date 23 Jul 2027Detected 24 Oct 2026
Products without listed protection (14)
| Drug | Earliest generic entry |
|---|---|
| Aleve Pm NDA 205352 diphenhydramine hydrochloride; naproxen sodium | open now no listed protection |
| Cipro NDA 020780 · 2 strengths ciprofloxacin | open now no listed protection |
| Cipro NDA 019537 · 2 strengths ciprofloxacin hydrochloride | open now no listed protection |
| Climara NDA 020375 · 6 strengths estradiol | open now no listed protection |
| Climara Pro NDA 021258 estradiol; levonorgestrel | open now no listed protection |
| Eovist NDA 022090 · 2 strengths gadoxetate disodium | open now no listed protection |
| Gadavist NDA 201277 · 6 strengths gadobutrol | open now no listed protection |
| Menostar NDA 021674 estradiol | open now no listed protection |
| Ultravist (Pharmacy Bulk) NDA 021425 · 2 strengths iopromide | open now no listed protection |
| Ultravist 300 NDA 020220 iopromide | open now no listed protection |
| Ultravist 370 NDA 020220 iopromide | open now no listed protection |
| Xofigo NDA 203971 radium ra-223 dichloride | open now no listed protection |
| Yasmin NDA 021098 drospirenone; ethinyl estradiol | open now no listed protection |
| Yaz NDA 021676 drospirenone; ethinyl estradiol | open now no listed protection |